Clinical Research Directory

Effects of Intraoperative Warming Methods on Hematologic Inflammatory Indices in Laparoscopic Cholecystectomy

Perioperative hypothermia is a frequent and preventable complication that may cause adverse outcomes such as increased blood loss, impaired coagulation, and delayed recovery. Various active warming techniques are used to maintain normothermia during anesthesia; however, their comparative effects on systemic inflammatory responses remain unclear. This randomized controlled clinical trial aims to evaluate the effects of different intraoperative warming methods on hematologic inflammatory indices - including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII) - in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. A total of eligible adult patients will be randomly assigned into four groups according to the intraoperative warming method applied: Control Group: No active warming applied. Forced-Air Warming (FAW) Group: Warming blanket system used throughout surgery. Fluid Warming (FW) Group: Intravenous fluids warmed to maintain normothermia. Combined Warming (FAW + FW) Group: Both forced-air and fluid warming applied simultaneously. Core body temperature and perioperative data will be recorded. Venous blood samples will be obtained preoperatively and 24 hours postoperatively to calculate inflammatory indices. The primary objective is to determine whether active intraoperative warming techniques modulate postoperative inflammatory markers compared to no warming. Secondary outcomes include intraoperative temperature trends, recovery times, and the incidence of hypothermia-related complications. The results are expected to identify the most effective warming strategy to minimize inflammation and optimize postoperative recovery in laparoscopic procedures.

Subcostal TAP Block Versus Combined Subcostal TAP and Recto-Intercostal Fascial Plane Block for Analgesia After Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is commonly associated with moderate postoperative pain, particularly during the early postoperative period. Inadequate postoperative analgesia may negatively affect patient comfort and recovery, increase opioid consumption, and contribute to opioid-related adverse effects. Therefore, effective multimodal analgesic strategies are of considerable importance in patients undergoing laparoscopic cholecystectomy. Subcostal transversus abdominis plane (TAP) block is a regional anesthesia technique used to provide analgesia for upper abdominal surgery. However, its analgesic coverage may be insufficient in some patients because of the complex innervation of the upper abdominal wall. The recto-intercostal fascial plane block has been described as a fascial plane block targeting the anterior branches of the thoracoabdominal nerves and may provide additional analgesic benefit when combined with subcostal TAP block. This study aims to compare the postoperative analgesic efficacy of bilateral subcostal TAP block alone with that of bilateral subcostal TAP block combined with recto-intercostal fascial plane block in patients undergoing elective laparoscopic cholecystectomy.

The Effect of White Noise on Sleep, Quality of Recovery, and Satisfaction in Patients Undergoing Laparoscopic Cholecystectomy

This randomized controlled trial aims to evaluate the effect of white noise on sleep, recovery quality, and satisfaction in patients undergoing laparoscopic cholecystectomy. In the postoperative period, patients encounter numerous physical and psychological stressors, such as pain, difficulty adapting to the hospital environment, immobilization, environmental noise, frequent nursing interventions, individual characteristics, and illness-related anxieties. These factors disrupt sleep patterns; a decline in sleep quality can negatively affect tissue healing, immune function, pain control, psychological well-being, and the overall recovery process. Consequently, patient satisfaction with the care process may also decrease. Although pharmacological methods are commonly used to manage postoperative insomnia, they are not always sufficiently effective and carry various limitations, such as sedation, drug interactions, and other adverse effects. Therefore, interest has grown in recent years regarding non-pharmacological interventions that are safe, cost-effective, easy to implement, and carry a low risk of side effects. White noise, one such intervention, can create a more favorable sleep environment by masking irregular environmental sounds, promote relaxation, and has the potential to improve sleep quality.

The Effect of Guided Imagery in Laparoscopic Cholecystectomy

This clinical trial examines the effects of guided imagery in adults recovering from laparoscopic gallbladder surgery. The study focuses on pain levels, vital signs, and the quality of recovery after surgery. The study addresses the following questions: * Do participants who receive guided imagery experience different levels of pain after surgery? * Do participants' vital signs change after guided imagery? * Does the quality of recovery differ between participants who receive guided imagery and those who do not? Participants are followed in two groups. One group receives an 18-minute guided imagery session in addition to standard care, while the other group receives standard care only. The results from the two groups are compared to assess the possible effects of guided imagery. During the study, participants' pain levels and vital signs are measured at planned time points. Their quality of recovery after surgery is also assessed.

Effect of Preoperative Melatonin on Quality of Recovery After Elective Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is one of the most commonly performed abdominal surgical procedures worldwide. Although the widespread implementation of Enhanced Recovery after Surgery (ERAS) protocols has improved perioperative outcomes, many patients continue to experience postoperative pain, sleep disturbance, anxiety, nausea, and fatigue, symptoms that collectively impair overall quality of recovery (QoR). Melatonin, an endogenous hormone that regulates circadian rhythm, also possesses anxiolytic, analgesic, antioxidant, and anti-inflammatory properties, positioning it as a valuable perioperative adjunct. However, most previous studies have evaluated melatonin primarily for isolated outcomes such as sleep quality or anxiety. Its effect on comprehensive postoperative recovery, assessed using validated patient-reported outcome instruments, remains insufficiently explored, particularly in laparoscopic cholecystectomy populations and in South Asian clinical settings. This prospective, randomized, double-blind, placebo-controlled trial (the MEL-REC trial) aims to evaluate the effect of preoperative oral melatonin on postoperative quality of recovery in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia. The study will be conducted in the Department of Anaesthesiology at Combined Military Hospital (CMH), Dhaka, Bangladesh, over a total study period of 18 months (January 2026 to June 2027), with patient recruitment planned for 8 months (May to December 2026) after taking approval from institutional review board. Eighty four adult patients aged 18-60 years with American Society of Anesthesiologists (ASA) physical status I-II will be randomly allocated in a 1:1 ratio into two equal groups (n = 42 per group) using computer-generated permuted block randomization with centralized pharmacy based allocation concealment. The melatonin group (Group M) will receive oral melatonin 6 mg administered 60 minutes before induction of anaesthesia and the placebo group (Group P) will receive an identical placebo tablet under the same conditions. Neither the participants, the treating anaesthesiologist, the outcome assessor, nor the data analyst will be aware of group allocation until database lock. All patients will receive a standardized anaesthesia and perioperative management protocol, including standardized postoperative analgesia. The primary outcome will be postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) score at 24 ± 2 hours after surgery. Secondary outcomes include postoperative sleep quality measured by the Richards-Campbell Sleep Questionnaire, change in preoperative anxiety (delta-VAS-A score), total opioid consumption during the first 24 hours expressed as intravenous morphine milligram equivalents, incidence of postoperative nausea and vomiting, and time to first rescue analgesic request. All postoperative outcomes will be assessed by a trained research assistant blinded to group allocation. Based on the available evidence, it is anticipated that patients receiving preoperative melatonin will demonstrate higher QoR-15 scores at 24 hours after surgery compared with the placebo group. The melatonin group is also expected to have improved postoperative sleep quality, reduced opioid consumption, and a greater reduction in preoperative anxiety. If a clinically meaningful benefit is confirmed, given its well established safety profile, low cost, and ease of oral administration, preoperative melatonin may represent a practical perioperative adjunct that can be readily incorporated into ERAS protocols for laparoscopic cholecystectomy. The trial will be prospectively registered in the Bangladesh Medical Research Council (BMRC) clinical trial registry or clinicaltrials.gov prior to recruitment.

RIPB Versus EOIPB for Pain Control After Laparoscopic Cholecystectomy

This prospective observational study aims to compare the effects of bilateral ultrasound-guided recto-intercostal plane block(RIPB) and bilateral ultrasound-guided external oblique intercostal plane block(EOIPB) on postoperative analgesia in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Both blocks are performed after anesthesia induction as part of routine preemptive multimodal analgesia practice. Patients who receive bilateral recto-intercostal plane block will be included in the RIPB group, and patients who receive bilateral external oblique intercostal plane block will be included in the EOIPB group. The primary outcome is cumulative intravenous tramadol consumption via patient-controlled analgesia during the first 24 postoperative hours. Secondary outcomes include postoperative pain scores at rest and during activity, rescue analgesic requirement, postoperative nausea and vomiting, time to mobilization, length of hospital stay, quality of recovery assessed using the Quality of Recovery-15 questionnaire, and block-related complications.

ESP vs. EXORA Blocks for Analgesia in Laparoscopic Cholecystectomy

Patients undergoing laparoscopic cholecystectomy may experience moderate to severe postoperative pain. Effective postoperative analgesia enhances patient comfort and accelerates recovery. This study aims to compare the effects of Erector Spinae Plane (ESP) and External Oblique and Rectus Abdominis Plane (EXORA) blocks on postoperative pain management and analgesic consumption. The study is designed as a prospective, randomized, double-blind trial. Patients will be randomly assigned to groups, and both practitioners and evaluators will be blinded to group assignments. Our hypothesis is that the EXORA block will provide superior analgesia and require less analgesic consumption compared to the ESP block. The results will be assessed in terms of postoperative pain management, patient comfort, and additional analgesic requirements.

AI and Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Today, the majority of gallbladder removals surgeries are done using minimally invasive techniques through small cuts to help patients recover faster. However, these procedures are technically more challenging because surgeons have a restricted view of the patient's anatomy, which can increase the risk of serious complications. Artificial intelligence (AI) tools have been developed to guide surgeons during surgery and help them make safer decisions that reduce the risk of injury to the patient. This study will use a randomized controlled trial to compare outcomes between surgeries with AI assistance and standard procedures without AI. Primary Objective: To determine whether the AI improves surgeons' ability to achieve the Critical View of Safety, a key step for safe gallbladder removal, compared to standard procedures. Secondary Objectives: * Determine whether the AI helps the surgeon perform more safe dissections compared to the standard procedures. * Collect surgeon feedback on the use of AI during the procedure

Subcostal TAP Block and EEG Dynamics in Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is a commonly performed minimally invasive surgical procedure. Despite its minimally invasive nature, surgical stimulation and pneumoperitoneum may cause pain-related physiological and neurophysiological responses during general anesthesia. This prospective observational study will evaluate patients undergoing laparoscopic cholecystectomy under general anesthesia. Patients will be observed according to the analgesic technique selected by the attending anesthesiologist as part of routine clinical care: intravenous remifentanil alone or remifentanil combined with an ultrasound-guided subcostal transversus abdominis plane (TAP) block. The study will examine the relationship between the use of subcostal TAP block and intraoperative analgesic requirements, Bispectral Index (BIS) values, electroencephalographic (EEG) dynamics, and burst suppression. Postoperative pain scores, additional analgesic requirements, quality of recovery, mobilization time, length of hospital stay, and patient satisfaction will also be evaluated.

Esketamine Combined With Magnesium Sulfate for Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy (LC), although minimally invasive, is frequently associated with postoperative fatigue syndrome (POFS), which can delay recovery and prolong convalescence. Esketamine, an NMDA receptor antagonist, has demonstrated potential benefits in reducing postoperative fatigue and pain through central sensitization blockade and anti-inflammatory effects. Magnesium sulfate, another NMDA receptor antagonist and physiological calcium channel blocker, offers complementary analgesic, anti-inflammatory, and cardiovascular-modulating properties. This randomized, double-blind, 2 × 2 factorial trial aims to evaluate the independent and combined effects of perioperative esketamine and magnesium sulfate on postoperative fatigue, recovery quality, pain, and intraoperative hemodynamics in patients undergoing LC, with the goal of identifying an effective and safe strategy to accelerate early postoperative rehabilitation.

ERAS (Enhanced Recovery After Surgery) and Multimodal Analgesia in Laparoscopic Cholecystectomy

This clinical study aims to evaluate the effects of multimodal analgesia management administered within an ERAS (Enhanced Recovery After Surgery) protocol on postoperative pain, length of hospital stay, early complications, and additional opioid requirements in patients undergoing laparoscopic cholecystectomy. The key questions addressed are: * Does ERAS-based multimodal analgesia reduce postoperative pain? * Does it shorten the hospital stay and lower early complication rates? * What is its potential to reduce the need for additional opioids? Participants: * Prospective Group: Patients managed with an ERAS multimodal analgesia protocol (including paracetamol, NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), and local wound infiltration analgesics) between April and July 2025. * Retrospective Group: Patient records from 2024 who were treated with a routine analgesia protocol. BThe study was planned with the actual number of patients who met the selection criteria within the predefined time frames. Consequently, a total of 63 patients were analyzed, with 30 patients in the prospective ERAS group and 33 patients in the retrospective control group.

Low-Flow Sevoflurane and Desflurane Anesthesia in Laparoscopic Cholecystectomy

Several studies have demonstrated that inhalational anesthetic agents such as desflurane and sevoflurane may cause varying degrees of postoperative sore throat, hoarseness, and cough in orotracheally intubated patients. However, data evaluating these outcomes under low-flow anesthesia conditions remain limited and insufficient. This single-center, prospective, randomized controlled study will be conducted in patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I-II, who are scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia and who provide written informed consent to participate in the study. The primary objective of the study is to compare the effects of low-flow desflurane and low-flow sevoflurane anesthesia on the incidence and severity of postoperative sore throat. The secondary outcomes include the evaluation of postoperative hoarseness and cough, the incidence of postoperative nausea and vomiting (PONV), and the total consumption of inhalational anesthetic agents.

ANI-Guided Anesthetic Desflurane Consumption

General anesthesia requires precise titration of inhaled anesthetics like desflurane and opioids like remifentanil to balance sedation, analgesia, and hemodynamic stability. The Analgesia/Nociception Index (ANI), derived from heart rate variability (HRV), quantifies parasympathetic tone to assess nociception-antinociception balance on a 0-100 scale, with lower values indicating nociceptive stress. ANI analyzes high-frequency HRV components, reflecting parasympathetic inhibition during painful stimuli, making it a reliable indicator of intraoperative nociception. Studies validate the utility of ANI in detecting nociceptive events during laparoscopic surgery. ANI-guided opioid titration reduces opioid consumption and stabilizes hemodynamics, enhancing perioperative outcomes.

Ultrasound-Guided Regional Blocks for Postoperative Analgesia After Laparoscopic Cholecystectomy

Ultrasound (US)-guided recto-intercostal fascial plane block (RIFPB) is a recently described abdominal wall block performed by injecting local anesthetic between the rectus abdominis muscle and the costal cartilage of the 7th rib. Due to the cranial attachment of the rectus muscle, this technique provides effective analgesia to the sternal, epigastric, and upper-mid abdominal regions, corresponding to the T6-T10/11 dermatomal levels. RIFPB may be used as an adjunct technique for thoracic procedures or as a standalone block for abdominal surgery. Ultrasound-guided transversus abdominis plane block (TAPB) is performed by injecting local anesthetic into the fascial plane between the internal oblique and transversus abdominis muscles. TAPB provides sensory blockade of the anterolateral abdominal wall at the T6-L1 dermatomal levels and is widely used for postoperative analgesia following abdominal surgeries, including laparoscopic cholecystectomy. This study aims to compare the effectiveness of US-guided RIFPB and TAPB on postoperative pain control after laparoscopic cholecystectomy.

Comparison of Ultrasound-Guided Erector Spinae Plane Block and Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Study

This study compared two ultrasound-guided regional anesthesia techniques for pain relief after laparoscopic gallbladder surgery: the modified thoracoabdominal nerve block through a perichondrial approach and the erector spinae plane block. Adults undergoing elective laparoscopic cholecystectomy under general anesthesia were randomly assigned to receive one of these two nerve blocks on both sides of the body before awakening from anesthesia. Both techniques used bupivacaine as the local anesthetic. After surgery, pain intensity, tramadol consumption, need for additional pain medication, nausea and vomiting, antiemetic use, and block-related complications were assessed during the first 24 postoperative hours. The main objective was to determine whether the two techniques differed in their ability to reduce postoperative tramadol consumption and provide effective pain relief.

ICOUGH Bundle and Postoperative Pain and Nausea After Laparoscopic Cholecystectomy

This study will use a randomized controlled experimental research design. The population of the study will consist of all adult patients who undergo laparoscopic cholecystectomy at the General Surgery Clinic of Atatürk University Research Hospital between December 2024 and September 2025. The data will be collected using a Descriptive Information Form and the Visual Analogue Scale. The research has received institutional approval and ethics committee approval. The study will be conducted with collaboration from healthcare professionals in the clinic after they have been informed. Patients who meet the inclusion criteria will be invited to participate in the study after being approached one day before surgery. Oral and written consent will be obtained from those who volunteer and agree to participate. The data will be analyzed using SPSS for Windows 22 software.

Intraperitoneal Dexmedetomidine Versus Magnesium as Adjuvants to Bupivacaine in Laparoscopic Cholecystectomy

Although both dexmedetomidine and magnesium sulphate have been individually evaluated as adjuvants to local anesthetics, direct comparisons between the two agents in intraperitoneal instillation during laparoscopic cholecystectomy remain limited. Understanding their relative efficacy and safety could provide valuable guidance for optimizing perioperative analgesia in these patients.

Mechanical Power During Different Ventilation Modes in Laparoscopic Surgery

This study investigates how different breathing machine (ventilator) settings affect the energy delivered to the lungs during surgery. Mechanical power is a measure of this energy, and high levels can sometimes lead to lung irritation. In clinical practice, a mode called Pressure-Regulated Volume Control (PRVC) is often used because it lowers the "peak" pressure in the airways, which is generally thought to be safer. However, doctors have noticed that even though the peak pressure goes down in PRVC mode, the total mechanical power displayed on the monitor might actually increase compared to the standard Volume-Controlled Ventilation (VCV) mode. In this study, patients undergoing gallbladder surgery will be monitored using both ventilation modes in a random order. The researchers will compare the machine-calculated mechanical power for both modes to see if the perceived benefit of lower peak pressure in PRVC actually results in lower overall energy transfer to the lungs.

Opioid-based Versus Opioid-free Anaesthesia for Laparoscopic Cholecystectomy

This is a prospective, randomized, parallel-group, double-blinded clinical trial. The study is approved by the DUHS institutional review board (IRB) and the trial will be registered at clinical trial registry. The participants of the study will be invited once they receive full trial information from the surgeons or the anesthetists during their pre-assessment visits. The study participants will join only for up to one day after the surgery (Post-operative day-1). The intervention consists of administration of dexmedetomidine infusion in opioid free anesthesia (OFA) group versus Nalbuphine IV bolus in opioid-based anesthesia (OA) group, five minutes before induction of anesthesia. For maintenance in OFA group dexmedetomidine infusion is to be continued whereas in OA group Nalbuphine IV bolus doses will be administered. Once the surgery is completed and after extubation and emergence from anesthesia, all the participants will be transferred to PACU from where they will be in turn discharged to the ward once they will fulfil the recovery discharge criteria. A multi-modal analgesia regimen along with a prophylactic antiemetic medication will be prescribed postoperatively to all the patients in the ward according to the standard protocol of the department.

EOIB for Pain After Laparoscopic Cholecystectomy

This prospective, randomized, controlled, assessor-blinded trial will evaluate whether bilateral ultrasound-guided external oblique intercostal block (EOIB) reduces postoperative opioid consumption and improves recovery after laparoscopic cholecystectomy, compared with no block.

External Oblique Intercostal Block (EOICB) for Laparoscopic Cholecystectomy

This single-center, prospective, randomized controlled trial aims to compare the effects of paravertebral block (PVB), external oblique intercostal (EOI) block, and intravenous patient-controlled analgesia (PCA) with tramadol on postoperative pain and opioid consumption in patients undergoing elective laparoscopic cholecystectomy. The primary endpoint is total tramadol consumption within 24 hours postoperatively. Secondary outcomes include pain scores, additional analgesic use, incidence of nausea/vomiting, mobilization time, and length of hospital stay.

Pre-incisional Infiltration With Ropivacaine Plus Diprospan for Relieving Postoperative Pain After Laparoscopic Surgery

Incisional infiltration is the simplest, safest, and most effective anesthesia method for preventing incision pain after laparoscopic surgery, but even using long-acting local anesthetics, the effectiveness of postoperative analgesia can only last for a relatively short period of time. Studies have shown that up to 80% of patients experience postoperative pain following laparoscopic surgery due to inflammation caused by surgical incisions and surrounding tissues, necessitating pharmacological relief. Inflammatory mediators released from the soft tissues around laparoscopic incisions not only significantly alters the chemical microenvironment at the peripheral terminals of nociceptors, directly inducing pain, but also sensitizes afferent fibers, contributing to peripheral sensitization. Numerous studies have shown that glucocorticoids not only can achieve anti-inflammatory and analgesic effects by inhibiting inflammatory cytokines and inflammatory responses but also can prolong the duration of action of local anesthetics. Preemptive incisional infiltration using local anesthetics with corticosteroids which have potent local anti-inflammatory properties may play a key role in preventing or reducing postoperative pain. The objective of this trial is to determine whether preemptive incisional infiltration with ropivacaine plus diprospan is superior to ropivacaine alone in relieving postoperative pain for adults undergoing laparoscopic surgery. The investigators also compare the effects of the two intervention measures on postoperative pain management, patient safety, and recovery quality.

Pre-incisional Infiltration With Ropivacaine Plus Triamcinolone for Relieving Postoperative Pain After Laparoscopic Surgery

Incisional infiltration is the simplest, safest, and most effective anesthesia method for preventing incision pain after laparoscopic surgery, but even using long-acting local anesthetics, the effectiveness of postoperative analgesia can only last for a relatively short period of time. Studies have shown that up to 80% of patients experience postoperative pain following laparoscopic surgery due to inflammation caused by surgical incisions and surrounding tissues, necessitating pharmacological relief. Inflammatory mediators released from the soft tissues around laparoscopic incisions not only significantly alters the chemical microenvironment at the peripheral terminals of nociceptors, directly inducing pain, but also sensitizes afferent fibers, contributing to peripheral sensitization. Preemptive incisional infiltration using local anesthetics with corticosteroids which have potent local anti-inflammatory properties may play a key role in preventing or reducing postoperative pain. The objective of this trial is to determine whether preemptive incisional infiltration with ropivacaine plus triamcinolone is superior to ropivacaine alone in relieving postoperative pain for adults undergoing laparoscopic surgery. We also compare the effects of the two intervention measures on postoperative pain management, patient safety, and recovery quality.

The Efficacy and Safety of Loxoprofen Sodium Patch in Relieving Postoperative Pain After Laparoscopic Surgery

Studies have shown that up to 80% of patients experience postoperative pain following laparoscopic surgery due to inflammation caused by surgical incisions and surrounding tissues, necessitating pharmacological relief. Inflammatory mediators released from the soft tissues around laparoscopic incisions not only significantly alters the chemical microenvironment at the peripheral terminals of nociceptors, directly inducing pain, but also sensitizes afferent fibers, contributing to peripheral sensitization. The investigators conducted a multicenter, prospective, randomized controlled clinical study to explore the use of Loxoprofen Sodium Patch for preoperative local incision analgesia in laparoscopic surgery patients. The investigators aim to observe whether this method can effectively alleviate postoperative incision pain, reduce the dosage of postoperative analgesics and the side effects caused using postoperative analgesics, improve patient satisfaction, and provide new ideas for postoperative analgesia in laparoscopic surgery patients, promoting rapid recovery after laparoscopic surgery.