Clinical Research Directory

Transversalis Fascia Plane Block Versus Low-Dose Intrathecal Morphine for Open Inguinal Hernia Repair

Open inguinal hernia repair is commonly associated with early postoperative pain, which may delay mobilization, reduce patient satisfaction, and increase opioid consumption. Low-dose intrathecal morphine may provide prolonged postoperative analgesia after spinal anesthesia; however, it may also be associated with opioid-related adverse effects such as nausea, vomiting, pruritus, urinary retention, sedation, and respiratory depression. The transversalis fascia plane block is an ultrasound-guided fascial plane block that targets the sensory innervation of the lower abdominal wall, particularly the T12-L1 dermatomal region and the ilioinguinal and iliohypogastric nerve distribution. Although TFP block has been evaluated in lower abdominal procedures, direct comparison with low-dose intrathecal morphine in open inguinal hernia repair is limited. This prospective, randomized, controlled, assessor-blinded trial aims to compare ultrasound-guided TFP block with low-dose intrathecal morphine in adult patients undergoing elective unilateral open inguinal hernia repair under spinal anesthesia. The primary outcome is total rescue opioid consumption during the first 24 postoperative hours. Secondary outcomes include pain scores at rest and with movement, time to first rescue analgesia, opioid-related adverse effects, quality of recovery, patient satisfaction, mobilization time, readiness for discharge, block success, sensory block distribution, and block-related complications.

Virtual Reality and Cryotherapy for Postoperative Pain and Anxiety After Cesarean Section

This randomized controlled trial aims to evaluate the effectiveness of virtual reality and cryotherapy, used separately and in combination, in reducing postoperative pain and anxiety among women undergoing cesarean section under spinal anesthesia. Participants will be randomly assigned to one of three intervention groups or a control group according to the study design. Postoperative pain and anxiety will be assessed using validated measurement tools at predetermined time points after surgery. The findings of this study may provide evidence for safe, non-pharmacological interventions to improve postoperative recovery and patient comfort following cesarean section.

Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Analgesia in Orthopedic Surgery

This clinical trial is a multiple-center, randomized, double-blind, placebo- and active-controlled parallel-group Phase II/III clinical trial, to evaluate the efficacy and safety of HL-1186 Tablets for Postoperative Analgesia in Orthopedic Surgery.

The Effect of Superficial Cervical Block Application on Postoperative Opioid Consumption in Patients Undergoing Anterior Cervical Discectomy Surgery

This randomized controlled trial aims to evaluate the effect of superficial cervical block on postoperative opioid consumption in patients undergoing anterior cervical discectomy surgery. Postoperative pain significantly impacts recovery and patient comfort in this type of surgery, where symptoms such as swallowing difficulties, occipito-cervical pain, and positional discomfort are common. While opioids are effective for pain control, their side effects, such as nausea, vomiting, and respiratory depression, may lead to complications, especially in cervical surgeries with potential airway risks. Superficial cervical block is a simple and safe regional anesthesia technique proven effective in managing pain after thyroid and carotid surgeries. However, its potential benefits in anterior cervical discectomy surgeries have not been extensively studied. Our hypothesis is that superficial cervical block can reduce postoperative opioid use and provide effective pain management for these patients. Additionally, investigators aim to compare opioid-related side effects and postoperative pain scores between groups with and without the block.

Sex Hormones, Postoperative Pain and Opioid Use

Aim 1- To identify relationships between sex hormone levels and postoperative pain and opioid use. Aim 2: To determine whether the effects of testosterone on postoperative pain and opioid use are mediated by immune factors

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.

SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients

SPINE-RISK VE is a prospective multicenter cohort study designed to develop and internally validate a multimodal preoperative predictive model for Failed Back Surgery Syndrome (FBSS), now classified as Persistent Spinal Pain Syndrome Type 2 (PSPS-T2) per ICD-11 (code MG30.51), in Venezuelan adults patients undergoing elective lumbar spine surgery. The model integrates three variable domains obtainable from routine preoperative evaluation at zero additional cost to the patient: (1) inflammatory laboratory biomarkers (C-reactive protein \[CRP\], neutrophil-to-lymphocyte ratio \[NLR\], albumin, glycated hemoglobin \[HbA1c\], erythrocyte sedimentation rate \[ESR\]); (2) preoperative lumbar magnetic resonance imaging (MRI) findings (Modic changes, Pfirrmann disc degeneration grade, foraminal stenosis, number of surgical levels, spondylolisthesis); and (3) validated psychosocial instruments (Patient Health Questionnaire-9 \[PHQ-9\], Pain Catastrophizing Scale \[PCS\], smoking status, benzodiazepine use, prior lumbar surgery). Analysis proceeds in two phases: Phase 1 applies multivariable logistic regression with Least Absolute Shrinkage and Selection Operator (LASSO) variable selection to generate a printable clinical nomogram; Phase 2 applies a random forest machine learning algorithm with 10-fold cross-validation. Model reporting follows Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis plus Artificial Intelligence (TRIPOD+AI) guidelines. SPINE-RISK VE aims to produce the first validated multimodal predictive model for PSPS-T2/FBSS was developed in a Latin American surgical cohort, providing neurosurgeons with an evidence-based preoperative risk stratification tool applicable without Additional technological infrastructure.

Use of a Vibration Tool for Postoperative Pain Control in Distal Radius Fractures

The purpose of this research study is to determine if using a vibration tool improves pain control after surgical treatment of distal radius fracture. Additionally, the investigators would like to determine if this tool has any impact on consumption of pain medications postoperatively.

Injection Site in Ultrasound-Guided Interscalene Block for Shoulder Arthroscopy

Ultrasound-guided interscalene block is commonly used for postoperative analgesia in patients undergoing shoulder arthroscopy. The location of local anesthetic injection may influence both block efficacy and the incidence of block-related complications. This randomized, double-blind clinical trial compares two different injection sites around the C5-C7 nerve roots using the same local anesthetic dose and volume. The study will assess block success, postoperative analgesia, opioid consumption, diaphragmatic function, and procedure-related complications.

The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery

In adult patients undergoing cardiac surgery, does adding an sPIP block to standard care compared to standard care alone result in a smaller decrease in PFTs?

Study of QL Analgesic Response and Extent

A total of 14-18 healthy volunteers will be included. There will be three different procedure days, separated by at least one week. On each visit, the subjects will receive a QL block, according to the randomization process. Each volunteer will undergo pre-procedure screening on the first visit. The blocks will be performed on the same side, by the same anesthesiologist, with at least one week between each block. An anterior QL block will be administered on one day, a posterior QL block on another, and a lateral QL block on the third. The order will be randomized, and both the subject and the research team member assessing the block will be blinded. To compare the dermatomal sensory block distribution, the investigators will use detailed mapping with pinprick, cold, and heat stimuli. A handheld dynamometric assessment of lower extremity strength. The testing will be performed 60 to 90 minutes after performance of the blocks.

Postoperative VR for Recovery After Bariatric Surgery

The objective of this study is to investigate whether the addition of immersive virtual reality (VR) in the immediate postoperative period to an enhanced recovery after surgery (ERAS) protocol could improve postoperative recovery from bariatric surgery.

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.

Efficacy of Preventive Ketamine on Postoperative Pain

* Although bariatric surgery is mainly performed laparoscopically, analgesic optimization is still essential to reduce complications and to improve the patients' comfort. In laparoscopic sleeve gastrectomy, the intraoperative peritoneal instillation of bupivacaine hydrochloride (30 ml, 0.25%) was known to be safe and effective in reducing postoperative pain, nausea, and vomiting. * Furthermore, usage of ketamine both as a pre and post-operative pain management is well established. Ketamine can be used solely or in combination with other co-adjuvant drugs, increasing their efficacy. Many therapeutic properties of ketamine have been attributed to its antagonism mechanism to N-Methyl-D-aspartate receptors.

Clinical Pharmacist-Led Perioperative Pain Management in Orthopedic Surgery: An Effectiveness Evaluation

This study aims to evaluate the effectiveness of a clinical pharmacist-led perioperative pain management model in orthopedic surgery. It is a randomized controlled trial involving patients undergoing major orthopedic procedures. Participants will be assigned to either a standard care group or an intervention group receiving comprehensive pharmaceutical care, including preoperative medication reconciliation, intraoperative monitoring, and postoperative analgesic optimization. The primary outcome is the incidence of moderate-to-severe postoperative pain. Secondary outcomes include opioid consumption, adverse drug reactions, and patient satisfaction. This study seeks to establish an evidence-based protocol for optimizing pain management in orthopedic settings.

QIPB vs SI-FICB for Postoperative Analgesia After Total Hip Arthroplasty

Total hip arthroplasty (THA) causes moderate-to-severe postoperative pain. The PROSPECT guideline recommends the supra-inguinal fascia iliaca compartment block (SI-FICB) for THA, whereas evidence for newer quadratus-lumborum-family blocks is limited. The quadro-iliac plane block (QIPB) is a recently described fascial plane block, and no study has compared QIPB with SI-FICB head-to-head in any surgical context. In this prospective, double-blind, patients undergoing elective THA who receive one of the two routinely used preoperative blocks (SI-FICB or QIPB, chosen by the attending anesthesiologist as part of routine care) are systematically observed and compared. The primary objective is to assess whether the postoperative analgesic efficacy of QIPB is non-inferior to SI-FICB, using the resting NRS pain score at 6 hours postoperatively as the primary endpoint (non-inferiority margin Δ = 1.3).

Feasibility of Breathwork Intervention With Older Adults After Knee Surgery

Postoperative complications after surgical procedures, including following total knee arthroplasty (TKA), have a negative impact on the health and well-being of surgical patients. Older adults (≥65 years) are particularly vulnerable to postoperative complications and their associated morbidities due to the biological aging process. Older adults comprise nearly half of surgical patients worldwide, and this number is expected to increase in the next 10-20 years as the aging population continues to grow. TKA is the most common procedure undergone by older adults, and the rate of TKA procedures is also expected to rise. Despite perioperative guidelines and protocols to prevent postoperative complications, the prevalence of postoperative complications following TKA is approximately 12%. Given these statistics, millions of older adults undergoing TKA may be at risk for postoperative complications and their associated morbidities in the coming decades. Therefore, additional interventions are needed to combat postoperative complications in this population. The body's natural response to surgery, also known as the surgical stress response (SSR), contributes to postoperative complications through complex mechanisms involving the autonomic nervous system (ANS). Increased sympathetic nervous system (SNS) activity, or the body's fight-or-flight response, causes dysregulation in feedback systems that regulate the stress response, potentially leading to poorer outcomes. Interventions, such as breathwork, that induce the parasympathetic nervous system (PNS), or the body's rest-and-digest response, have been shown to balance the ANS, regulate stress biology, and improve outcomes. This study will examine the feasibility of adding a breathwork intervention (Box Breathing), compared to an attention control, to standard perioperative care for older adults undergoing TKA. This study will also examine the proof of concept that Box Breathing, compared to an attention control, may help regulate the SSR by assessing an objective measure of stress-related biology, diurnal cortisol rhythm, and gathering self-report information on pain, anxiety, depression, and quality of recovery following TKA.

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.

Rectointercostal Plane Block (RICPB) for Laparoscopic Cholecystectomy

This prospective randomized controlled trial is designed to evaluate the analgesic efficacy of ultrasound-guided rectointercostal plane block (RICPB) in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomized to receive unilateral right-sided RICPB at the end of surgery. Postoperative opioid consumption, Numeric Rating Scale (NRS) pain scores, and postoperative complications will be assessed to determine the effectiveness of RICPB in postoperative pain management.

A Study of TLC590 for Postsurgical Pain Following Bunionectomy

This is a Phase 3, randomized, double-blind, comparator- and placebo-controlled study to evaluate analgesic efficacy and safety of TLC590 via local infiltration in adult subjects following bunionectomy.

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.

The Perioperative Pain Self-Management Program Trial

This study will trial the impact of teaching surgical patients a pain self-management approach to compliment medical post-surgical pain management.

Pain Control After Aortic EndoaneurYsmEctomy (POPEYE)

Open abdominal aortic aneurysm repair (OR-AAA) is an operation associated with high morbidity, and has 30-day mortality rates of between 4 and 14%. Post-operative pain management represents a primary anesthetic focus. A better analgesia, in addition to being desirable for the patient, can potentially reduce complications associated with postoperative pain and ensure faster functional recovery. The modern concept of multimodal analgesia involves the association of multiple drugs and/or analgesic techniques to maximize the quality of analgesia and reduce the side effects of the individual methods. In this context, the addition of epidural analgesia (EA) to the intravenous administration of "traditional" analgesic drugs has assumed the role of gold standard in many surgeries, including OR-AAA. Over time, EA has proven to be a better analgesic technique than the use of intravenous opioids alone, however there is much uncertainty regarding its ability to reduce complications, morbidity and mortality of patients. For some time, efforts to research effective, less invasive and safe anesthetic alternatives, have been directed towards the development of multimodal analgesia protocols with the aim of reducing complications and ensuring faster recovery. New approaches to post-operative pain management are emerging, including rectus sheat block (RSB). Currently there is no evidence regarding the effectiveness of RSB in pain control after OR-AAA. In this context, the study aims to compare two different post-operative pain management protocols, with the aim of verifying whether the use of RSB can guarantee a non-inferior level of analgesia with reduction of complications compared to AE.

Interscalene Block Versus Infraspinatus-Teres Minor Interfascial Plane Block for Shoulder Arthroscopy

This prospective randomized controlled study aims to compare the effects of interscalene block, infraspinatus-teres minor interfascial plane block, and a control group on postoperative analgesia and diaphragmatic function in patients undergoing shoulder arthroscopy. A total of 120 patients will be enrolled and allocated into three groups. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and diaphragmatic function will be evaluated and compared among the groups. The study seeks to determine whether the infraspinatus-teres minor interfascial plane block can provide effective postoperative analgesia with less impact on diaphragmatic function compared with interscalene block.