Clinical Research Directory

Thoracic Surgery Intercostal Block Trial With Liposomal vs. Hydrochloride Bupivacaine

This randomized controlled trial evaluates the analgesic effects of liposomal bupivacaine compared to bupivacaine hydrochloride in intercostal nerve block for patients undergoing thoracoscopic lung surgery. Postoperative pain remains a significant issue in thoracic procedures, often leading to complications like pneumonia or delayed recovery. The investigators hypothesize that liposomal bupivacaine, with its extended-release properties, will provide superior pain relief beyond 24 hours compared to standard bupivacaine or no block. Participants will be randomized 1:1:1 to liposomal bupivacaine group , bupivacaine hydrochloride group , or control group . Primary outcome is the area under the curve of pain scores from 25-72 hours post-surgery. Secondary outcomes include opioid consumption, recovery quality (QoR-15), and other complications.

Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery

This study aimed to evaluate the effectiveness of serratus posterior superior intercostal plane (SPSIP) block in managing postoperative pain in patients undergoing arthroscopic shoulder surgery.

SPS Block vs. Surgical Intercostal Block for Chronic Pain After Thoracoscopic Surgery

This study aims to evaluate the efficacy of ultrasound-guided Serratus Posterior Superior (SPS) block compared to surgeon-administered intercostal blockade in preventing chronic pain at 3, 6, and 12 months following Video-Assisted Thoracoscopic Surgery (VATS).

Effect of Dexmedetomidine Versus Dexamethasone as Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block on Postoperative Analgesia in Myasthenic Patients Undergoing Thoracoscopic Thymectomy

This current comparative study involved 54 patients undergoing thoracoscopic thymectomy who were distributed randomly into three equal groups to receive ultrasound (US)-guided ESPB using 20 ml bupivacaine 0.25% (group B) , 20 ml bupivacaine 0.25% with 8 mg dexamethasone (group BS), 20 ml bupivacaine 0.25% with dexmedetomidine 1mcg/kg (group BM). The time till the first postoperative rescue analgesic requested was the primary outcome. The secondary outcomes included the postoperative pain scores and analgesic consumption.

Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries

Tourniquet, a compressing device, otherwise its use in intravenous regional anesthesia, is commonly used in particular orthopedic surgeries. From the previous documented effectiveness and safety of intravenous (IV) administration of ketorolac in the circulatory-isolated limb as a part of intravenous regional anesthesia; we hypothesized that in orthopedic surgeries done with tourniquet, intravenous (IV) administration of ketorolac after tourniquet inflation, will act as intravenous regional analgesia. So, it will prolong the postoperative analgesic duration as a primary outcome.

REctus Sheath Trial

Regional anesthesia techniques (or nerve blocks) are used to provide sensory blockade over the abdominal wall. The most established technique is thoracic epidural. This provides bilateral spread but is also associated with neuraxial complications, which has led to a decrease in clinical usage. The rectus sheath block (RSB) is an established regional anesthesia technique used to provide somatic analgesia to the midline anterior abdominal wall by depositing local anesthetic in the posterior rectus sheath, thereby targeting the terminal anterior branches of the lower thoracic intercostal nerves. The conventional approach involves placing the ultrasound (US) probe transversely across the rectus abdominis muscle and advancing the needle in-plane either lateral-to-medial or medial-to-lateral. While this technique achieves spread within the sheath, the cephalocaudal distribution of local anesthetic may be suboptimal, potentially limiting the extent of dermatomal coverage. A longitudinal probe orientation, with needle insertion from cephalad to caudad, may theoretically facilitate a more extensive cranio-caudal spread by aligning the injection axis with the anatomical fascial plane of the posterior rectus sheath. However, the relative efficacy of these two approaches has not been investigated in a controlled, comparative setting. Thus, this randomized, single-blinded trial aims to evaluate the dermatomal sensory distribution and ultrasound-assessed local anesthetic spread achieved by the transverse versus longitudinal in-plane approaches to ultrasound-guided RSB in healthy adult volunteers. To compare the dermatomal sensory block distribution, investigators will use dermatomal mapping with pinprick, and cold.

PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301)

The goal of this clinical trial is to evaluate the analgesic activity of PF614 (an oral oxycodone prodrug extended-release analgesic) for control of postsurgical pain in subjects scheduled for abdominoplasty surgery. The main question to be answered is: • To assess the analgesic efficacy of PF614 compared to placebo in subjects with moderate to severe pain following abdominoplasty. Participants will be asked to take oral blinded doses of study medication at about one hour before surgery starts, and then every 12 hours after surgery for up to 4 days. Participants will be asked to: * Rate their pain on a 0-10 numerical rating scale (NRS) at various timepoints up to 5 days following surgery; * Tell us about the need for rescue medication if they continue to have moderate-to-severe pain; * Tell us about any side effects or adverse effects that they may experience to help us understand the safety and tolerability of the test medications; * Provide periodic blood samples to help us understand how much study drug is in their system. Participants will stay in a clinic setting and be monitored for safety for 5 days following surgery. We anticipate that participants will be discharged on Day 5, pending medical review, and then keep a diary to record study-related pain and adverse effects for an additional 2-4 days after discharge.

Meloxicam in Mohs Micrographic Surgery

The goal of this clinical trial is to explore alternative methods of postoperative pain control in Mohs micrographic surgery. The main aims are: * To provide more information to the Mohs surgery community regarding postoperative pain control. * Reducing pain improves the overall comfort and well-being of patients, leading to a better post-operative experience. * To provide patients with an alternative and potentially superior NSAID for pain control (compared to standard-of-care ibuprofen). Researchers will compare 1) a single of dose Meloxicam 7.5 mg, followed by acetaminophen 500 mg; 2) a single dose of Meloxicam 15 mg, followed by acetaminophen 500 mg; 3) a single dose of acetaminophen 500 mg, followed by alternating ibuprofen 200 mg and acetaminophen 500 mg to see which better moderate pain control and patient satisfaction. Participants will be asked to complete pain and patient satisfaction surveys.

Nalbuphine Timing Effects on Hemodynamics and Analgesia in Elderly Patients

In total knee arthroplasty (TKA), the use of a tourniquet and controlled hypotension is common. However, ischemia-reperfusion injury induced by the tourniquet and inappropriate controlled hypotension can lead to cardiac and cerebral damage in patients. Consequently, maintaining hemodynamic stability, ensuring adequate cerebral perfusion, and achieving controlled blood pressure during the perioperative period are critical factors influencing patient outcomes. Postoperatively, patients typically experience moderate to severe pain. Severe postoperative pain can result in prolonged hospital stays, increased readmission rates, elevated opioid consumption, and associated nausea and vomiting. Therefore, exploring effective multimodal postoperative pain management strategies is essential. Nalbuphine, an opioid analgesic acting as a full kappa-receptor agonist and a partial mu-receptor antagonist, is considered to provide analgesic efficacy equivalent to morphine while potentially offering advantages in maintaining hemodynamic stability. This study aims to investigate the effects of administering equivalent doses of nalbuphine at different perioperative time points on analgesia and hemodynamics in elderly patients undergoing knee arthroplasty.

EOI Block in Otoplasty With Rib Cartilage Graft

This randomized controlled trial aims to evaluate the effect of ultrasound-guided external oblique intercostal (EOI) fascial plane block on postoperative pain control and recovery in pediatric patients undergoing otoplasty with rib cartilage graft under general anesthesia. Participants aged 13 to 18 years will be randomly assigned to receive either EOI block with 0.2% ropivacaine or no block. Primary outcome is total opioid consumption within 24 hours after surgery. Secondary outcomes include NRS pain scores, incentive spirometry performance, incidence of atelectasis, and patient satisfaction.

Effects of Pericapsular Nerve Group Block on Postoperative Recovery for Total Hip Arthroplasty

The hypothesis of this study is that patients who undergo PENG block in before Total Hip Artroplasthy (THA) surgery with spinal anesthesia will have reduced postoperative pain scores, less need for opioid analgesics and earlier mobilisation.

REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss

The purpose of this research study is to learn how two different supportive programs may help women feel better after surgery. This study will measure if one type of supportive program is more useful than the other for improving wellbeing after surgery.

Effect of Virtual Reality on Patient Outcomes and Satisfaction in Total Knee Replacement

This study aims to evaluate the effectiveness of virtual reality (VR) in managing preoperative anxiety and postoperative pain in patients undergoing total knee replacement. Investigators will assess the impact of preoperative VR training on anxiety levels, explore the effectiveness of relaxing and distracting VR videos for pain management after surgery, and determine the optimal timing for VR application by comparing different VR intervention times. Our goal is to identify how VR can improve both the emotional and physical recovery process for patients undergoing knee replacement surgery.

Erector Spinae Plane Block Versus Iliohypogastric/Ilioinguinal Nerve Block for Post-Hysterctomy Pain Relief

The goal of this clinical trial is to compare the degree of pain relief between two techniques of regional anesthesia given to ladies undergoing hysterectomy under general anesthesia. One group of patients will have a local anesthetic injected between muscle layers in their back (ultrasound guided Erector Spinae plane Block). The other group will have a local anesthetic injected around specific nerves in their abdomen (ultrasound guided Ilio-hypogastric / ilio-inguinal nerve block ). Researchers will compare the duration of postoperative pain relief , the degree of pain relief and any possible side effects of either techniques.

Minimally Invasive Esophagectomy Pain Control Trial

A pilot randomized controlled trial comparing intercostal nerve blocks, cryo-ablation plus intercostal nerve blocks, and serratus plane catheter plus intercostal nerve blocks in patients undergoing esophagectomies with minimally invasive thoracic approaches.

Determining the Optimal Dose of Intrathecal Morphine for Post-Cesarean Analgesia

Using spinal or epidural anesthesia (known as neuraxial blocks) is the gold standard for pain control during childbirth, especially in cesarean sections (C-sections). However, many women experience moderate to severe pain after a C-section, which can affect both their physical and emotional well-being, and even impact their ability to care for their newborn. Unfortunately, this pain is often not treated effectively, which can lead to increased sensitivity to pain or even chronic postoperative pain. One effective way to manage this pain is by giving opioids directly into the spinal fluid (subarachnoid space). This method allows doctors to use much smaller doses than would be needed if the same medication were given through a vein, which also helps avoid many of the common side effects of opioids like respiratory depression, nausea, pruritus, and constipation. Common opioids used in this setting include fentanyl, sufentanil, and morphine. These drugs behave differently depending on their chemical properties. For example, drugs that are more fat-soluble work faster, while those that are less fat-soluble tend to last longer. Morphine, which is less fat-soluble than the others, provides strong and long-lasting pain relief. When injected spinally, its effect can last 18-24 hours, with the pain relief starting 1-2 hours after the injection. Its performance is comparable to that of epidural anesthesia or nerve blocks. Researchers have studied a wide range of spinal morphine doses (from 20 to 500 micrograms) to find the most effective and safest dose. Most of these studies are small or use set doses without clear reasoning. Recently, a method called sequential allocation has become popular for finding the best dose more accurately. About the Study This research aims to find the ideal dose of spinal morphine when it's given with a fixed amount of fentanyl and varying doses of ropivacaine (a local anesthetic) during spinal anesthesia for C-section in healthy full-term parturients. The goal is to find the dose that provides adequate analgesia (pain score under 3 out of 10) for at least 12 hours after surgery. This is a prospective, non-randomized, double-blind study. The study follows ethical standards and all participants sign an informed consent form. Two anesthesiologists are involved in each case: one handles the spinal injection and dose decision (based on the previous patient's response), while the other monitors the patient and collects the data without knowing the dose used. Anesthetic Technique Spinal anesthesia is done using standard procedures. A very fine needle (25 or 27 gauge) is used to inject a mixture of fentanyl (15 mcg), a variable dose of ropivacaine (based on somatometrics), and a variable dose of morphine (based on the algorithm). The mixture is injected slowly (1 ml every 10 seconds), with the needle facing toward the head. After surgery, all women receive additional pain medications like paracetamol and NSAIDs as part of a multimodal pain relief approach. How the Morphine Dose is Decided The dose of morphine changes based on whether the previous participant had effective pain relief. Pain relief is considered successful if the pain score stays at or below 3 (on a 0-10 scale) for at least 12 hours after the spinal injection. For the first woman in the study, the starting dose is chosen based on published research. Then: * If the previous participant had good pain control (NRS ≤3 for 12 hours), the dose for the next woman is reduced by 20 micrograms. * If pain control was poor (NRS \>3 within the first 12 hours), the dose is increased by 40 micrograms. This up-and-down adjustment continues for each new participant.

Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries

This is a double-arm randomized control trial evaluating the impact of preoperative opioid-free analgesia on time to trial of void in ambulatory urogynecologic surgeries. The investigators hypothesize that receipt of acetaminophen, celecoxib and gabapentin preoperatively versus acetaminophen alone will reduce the time to trial of void in patients undergoing same-day minor urogynecologic procedures.

Electrical Stimulation for Erector Spinae Plane Catheter Insertion

The erector spinae plane (ESP) block has been studied for analgesia in shoulder surgery as a phrenic nerve-sparing alternative. However, successful ESP catheter placement appears multifactorial, with failure mechanisms including lamination, plane collapse, or catheter overcoiling. Electrical stimulation (ES) is a common technique used in regional anesthesia to detect possible intraneural placement. ES of the erector spinae muscle complex may objectively guide proper interfascial catheter placement and improve local anesthetic spread. The primary goal of this study is to establish if ESP catheter placement with the addition of ES to ultrasound (US) guidance facilitates accurate catheter placement. This study will further characterize postoperative analgesia and the incidence of brachial plexus stimulation for patients who receive ES-assisted ESP catheter placement.

Effect of Transauricular Vagus Nerve Stimulation on Postoperative Pain Management in Video Assisted Thoracic Surgery

Transcutaneous auricular vagus nerve stimulation (taVNS) is a novel pain management technique that has gained popularity in recent years due to its non-invasive nature and ease of operation. Current literature has substantiated its efficacy in managing pain syndromes and chronic pain. However, there is a paucity of evidence regarding its effectiveness in treating acute postoperative pain. This project aims to explore the efficacy of taVNS in postoperative pain management, with a focus on video-assisted thoracic surgery(VATS). The investigators have designed a double-blind, single-center, randomized controlled clinical trial, planning to enroll 116 patients scheduled to undergo VATS(including segmentectomy or lobectomy) under general anesthesia at Peking Union Medical College Hospital. Participants will be divided into an intervention group (receiving taVNS) and a sham intervention group (receiving sham-taVNS), and will undergo a 2-hour intervention on the first postoperative day. The primary outcome is the pain relief rate, defined as a reduction of 15mm or 30% in the VAS (1-100mm) score immediately before and after the intervention on the first postoperative day. Secondary outcomes include: the proportion of patients with inadequate analgesia within three days after intervention; the difference in VAS scores immediately before and after the intervention on the first postoperative day; the incidence of opioid-related and taVNS-related side effects from the first to the third postoperative day after intervention; the number of effective and ineffective PCA presses (if used) from the first to the third postoperative day after intervention; the specifics and frequency of additional analgesic measures taken by patients from the first to the third postoperative day after intervention; the difference in RCSQ scores on the night of surgery and the night after intervention; and the probability of patients experiencing surgery-related pain three months after surgery. Follow-up period for this study will be three months after surgery.

The Correlation Between Intraoperative End Tidal Carbon Dioxide, Perfusion Index and Pulse Variability Index on Postoperative Nausea Vomiting and Pain

Postoperative pain, which is frequently encountered in laparoscopic operations, has been examined in different studies with end tidal CO2 (end tidal carbon dioxide), total insufflated gas amount and PI (Perfusion index) parameters. PONV (postoperative nausea and vomiting), which is encountered more frequently than pain in the postoperative period, has been examined in relation to end tidal CO2. In this study, it was aimed to evaluate the development of postoperative pain and PONV, which affect recovery and patient comfort, by comparing the relationship between end tidal CO2, PI and PVI (Pulse variability index).

Analgesic and Anti-inflamatory Effect of Vit. B

Vitamin C, also known as ascorbic acid, is a potent reducing agent and antioxidant that plays a crucial role in various metabolic processes.Vitamin B complex, a group of eight essential B vitamins, plays a crucial role in cellular metabolism, energy production, and maintaining nervous system health. There are few available studies on the effects of vitamin B injection on plasma inflammatory markers and its adjuvant analgesic effect along with the routine multimodal analgesia. Considering limited research and existing controversies in this field, the aim of present study is to evaluate the effects of preoperative and intraoperative vitamin B12 administration compared to vitamin C when used as a component of the multimodal analgesic technique in patients undergoing laparoscopic cholecystectomy.

Effectiveness of Fentanyl-Added TAP Block in Laparoscopic Cholecystectomy

The aim of this study is to evaluate the effectiveness of adding fentanyl to the TAP block in laparoscopic cholecystectomy cases. It is hypothesized that the addition of fentanyl to the TAP block will enhance the quality of postoperative analgesia and prolong the duration of blockade compared to the TAP block performed with bupivacaine alone. The study aims to determine the most effective approach by comparing these two treatment methods with a control group.

The Effect of Adding an IPACK Block to the Adductor Canal Block on Total Knee Arthroplasty Surgery

Total knee arthroplasty (TKA) is a frequently performed major orthopedic surgery, where most patients experience severe postoperative pain. Pain-related delays in patient mobilization can lead to thromboembolism, deep vein thrombosis, surgical site infection, and increased risk of hospital-acquired infections due to prolonged hospital stay. Optimal postoperative knee analgesia is crucial not only for patient comfort and satisfaction but also for accelerating mobilization, functional recovery, and discharge from the hospital. To facilitate early ambulation and superior performance, multimodal analgesia and motor-sparing blocks are increasingly utilized

Incidence of Chronic Pain After Thoracic Surgery

Thoracotomy and video-assisted thoracic surgery procedures are frequently performed in thoracic surgery. It is widely accepted that thoracotomy causes severe acute pain. This prolongs the discharge time of the patients, and increases the frequency of postoperative pulmonary complications and postoperative morbidity. Postoperative acute pain may cause chronic thoracotomy pain in the later period, and may adversely affect the quality of life of the patients. Video-assisted thoracic surgery (VATS) has become the standard procedure in minor and major lung surgeries. Postoperative pain is seen in patients undergoing VATS, although it is not as severe as after thoracotomy. As in thoracotomy, this affects the postoperative pulmonary complications and the discharge time of the patients. Likewise, this pain can cause chronic pain. In this study, it was aimed to analyze the symptoms of chronic pain in the 3rd and 6th months postoperatively in patients who had undergone thoracic surgery.