Clinical Research Directory

Precision Pain Management - A Randomized Clinical Trial Assessing the Efficacy of Suzetrigine on Postoperative Analgesia Among Surgical Patients at Higher Risk for Persistent Postoperative Opioid Use (POU)

The purpose of the study is to investigate the efficacy of suzetrigine for treatment of acute postoperative pain among surgical patients identified as high risk for persistent postoperative opioid use (POU). Using a validated artificial intelligence predictive model (termed SurgNet-POU) developed by the PI, electronic health record (EHR) data will be queried from all prospective surgical patients undergoing orthopedic surgery and inputted into the model to predict risk of POU (defined as requiring opioids ≥ 3 months after surgery). Those identified as high risk by the SurgNet-POU will be eligible candidates for this study. Suzetrigine (Vertex Pharmaceuticals) is an FDA-approved non-opioid oral analgesic that acts as a selective Nav1.8 sodium channel blocker. It has been shown to have efficacy in post-surgical pain and has compared favorably to placebo and similar to some opioids, without the risk of addiction or other adverse events related to opioids. Consented participants will be randomized to one of two arms: (1) standard care (termed standard care) defined as usual prescribing outpatient opioid analgesic protocols per surgical team; versus (2) standard care combined with 14-day regimen of suzetrigine. Those randomized to the suzetrigine arm will receive 100mg suzetrigine PO \~ 1-2 hours prior to surgery and take 50mg po twice a day for 14 days postoperatively. The primary outcome will be total opioid consumption over 14 days postoperatively. Secondary outcomes include average, highest and lowest pain scores at 7, 14, 30, and 90 days after surgery; and opioid consumption at 7, 30, and 90 days after surgery.

SPSIP Block for Pain Control After Breast Reduction Surgery

The goal of this clinical trial is to learn whether an ultrasound-guided serratus posterior superior intercostal plane block (SPSIP block) can lower the need for opioid pain medicine after breast reduction surgery. The main question it aims to answer is: Does adding an SPSIP block to standard anesthesia and pain treatment lower opioid use during the first 24 hours after surgery? Researchers will compare participants who receive standard anesthesia and pain treatment with participants who receive standard anesthesia and pain treatment plus an SPSIP block. Participants will: * Have planned bilateral breast reduction surgery under general anesthesia * Be randomly assigned to the SPSIP block group or the control group * Receive standard local anesthetic infiltration during surgery and standard pain treatment after surgery * Have their pain score and pain medicine use recorded during the first 24 hours after surgery * Be followed for safety and complications for 30 days after surgery

Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery

Urologic surgery has advanced with new technologies to allow less invasive management of common afflictions such as kidney stones, these procedures are notoriously painful as the ureter must be dilated to accommodate any instruments, and a ureteral stent is often left following surgery to allow for adequate healing. Unfortunately, stents are poorly tolerated by a significant number of patients, with up to 100% complaining of bothersome pain and 10% of patients with unplanned healthcare visits. Further complicating kidney stone management is the frequency of concurrent chronic kidney disease (CKD) or acute kidney injury (AKI) that prohibits many patients from taking NSAIDs which limits pain management options. There is now a push to treat these patients with multimodal analgesia to provide better care and reduce opioid use. Suzetrigine is a new a first-in-class selective inhibitor of the NaV1.8 sodium channel that functions as a non-opioid analgesic developed to treat acute pain and neuropathic pain. This study assesses the addition of suzetrigine to standard-of-care multimodal analgesia. We hypothesize a demonstrated decrease in opioid use, decrease Emergency Room visits within 30 days, decrease the number of unplanned care encounters.

Opioid Education Ventral Hernia Repair

The goal of this study is to learn if opioid education before surgery affects prescribed opioid use after surgery in participants who are undergoing a ventral hernia repair. The main question it aims to answer is, does opioid education before surgery lower the number of opioid pills taken during recovery after a ventral hernia repair? Researchers will compare participants who watch an opioid education video before surgery to participants who watch a ventral hernia repair education video before surgery to see if those who watch an opioid education video take less prescribed opioid pills during recovery. Participants will watch a roughly 2-minute video in office the day their ventral hernia repair is scheduled, watch the same video the day of their surgery and be asked to report how many prescription opioid pills they took during recovery and return any left-over prescription opioid pills for disposal at their 1 month follow up appointment.

Suzetrigine in Total Hip Arthroplasty

Total hip and knee joint replacements are among the most common and painful orthopedic procedures performed worldwide, often requiring intensive analgesia to support early ambulation and recovery. Despite widespread use of multimodal regimens, many patients still rely on opioids, which can cause sedation, nausea, constipation, and long-term dependency. Evaluating Suzetrigine in this high-need population may improve recovery trajectories, reduce opioid consumption, and support enhanced recovery protocols. Given the growing surgical volume and the emphasis on opioid-sparing strategies, rigorous investigation of Suzetrigine's efficacy in joint replacement is of high clinical value. In this study, patients undergoing primary total hip replacement will be randomized to receive either Suzetrigine or placebo for seven days, with the loading dose administered prior to surgery. The primary outcome is cumulative 48-hour opioid consumption in oral morphine equivalents starting from entry into the post-anesthesia care unit (PACU).

Postoperative Opioid Consumption of Serratus Posterior Superior Intercostal Plane Block Versus Thoracic Paravertebral Block

Previous studies found that paravertebral and thoracic epidural continuous infusions of opioid-free local anaesthetic were found to be comparable, but paravertebral analgesia (PVA) was associated with less respiratory complications and hypotension. The newly emerging Serratus posterior superior intercostal plane block (SPSIPB) provided excellent analgesia in most studies that have focused on video-assissted thoracoscopic surgery (VATS) and breast surgery. The aim of this clinical trial is to achieve better high quality pain control with less opioid consumption either by Serratus Posterior Superior Intercostal Plane Block (SPSIPB) or Thoracic Paravertebral Block after Open thoracotomy. This study will assess and compare the analgesic efficacy of both blocks to reduce opioid consumption, the efficacy of both blocks on postoperative respiratory functions after open thoracotomy. The main question it aims to answer is: Is there a difference between Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Thoracic Paravertebral block following open thoracotomy as regard postoperative opioid consumption, postoperative pain score, and postoperative respiratory functions? All patients will take a single dose of local anesthesia either through serratus posterior superior intercostal plane block (SPSIPB) or thoracic paravertebral block and the end of open thoracotomy then total opiod consumption willbe recorded after 24 hours postoperatively.

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

This prospective, interventional, open-label, phase 3 randomized study evaluates a multimodal analgesia discharge pathway to reduce automatic opioid prescribing following routine robotic-assisted laparoscopic prostatectomy (RALP). Patients are counseled on post-operative pain management and then may opt into or out of the study with randomization to discharge prescriptions including (A) multimodal plan with additional automatic opioid prescription or (B) multimodal plan alone and instruction to call phone line to request opioid prescription if pain management is insufficient. Additionally, a cohort of historical controls prior to implementation of the study is also prospectively assessed as a pre-study baseline. The primary outcome is postoperative opioid consumption. Secondary outcomes include bowel function recovery, unplanned care encounters including emergency department visits or postoperative phone calls, and same-day discharge rates.

Rectus Sheath Block Versus Transversus Abdominis Plane Block for Analgesia in Laparoscopic Bariatric Surgery

This randomized controlled trial aims to compare the analgesic efficacy of rectus sheath block (RSB) and transversus abdominis plane block (TAPB) in patients undergoing laparoscopic bariatric surgery. Both techniques are regional anesthesia methods used as part of multimodal analgesia to reduce postoperative pain and opioid requirements. Eligible participants will be randomly assigned to receive either a RSB or a TAPB after general anesthesia. Postoperative pain scores, opioid consumption, recovery outcomes, area of sensory loss, time to first rescue analgesia, and block-related adverse events will be assessed and compared between the two groups. This study will help determine which regional anesthesia technique provides more effective postoperative analgesia for laparoscopic bariatric surgery

Comparison of Pain Relief Methods for Hip Surgery: A Study on Two Different Nerve Block Techniques

This prospective randomized comparative study aims to compare the analgesic efficacy of pericapsular nerve group block (PENG) and lumbar erector spinae plane block (L-ESP) groups to relieve postoperative pain in participants over the age of 18 undergoing total hip arthroplasty under spinal anesthesia. The main question it aims to answer is: To demonstrate whether PENG block or L-ESP block is more effective in postoperative analgesia in patients undergoing total hip arthroplasty surgery based on pain scores, opioid consumption, and patient satisfaction. Total hip arthroplasties cause severe pain with movement in the postoperative period. After surgery, the movements of the participants are severely restricted, which increases the possibility of complications. In this study, the participants' pain status, VAS score, opioid consumption through patient-controlled analgesia, and patient satisfaction will be measured with a questionnaire for 24 hours at predetermined time points and then compared. Both types of blocks have pain-relieving effects. This study will only investigate which one is more effective in reducing pain, and there will be no deficiency in relieving the pain of the participants.

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.

Suzetrigine for Opioid-Free Recovery After Cesarean Delivery

The goal of this clinical trial is to determine whether suzetrigine increases the proportion of patients who remain completely opioid-free from completion of surgery through 72 hours after cesarean delivery. The main question it aims to answer is: Does adjunctive suzetrigine, when added to a standardized multimodal postoperative analgesic regimen, increase the proportion of patients who remain opioid-free during the first 72 hours after cesarean delivery? Researchers will compare suzetrigine to a placebo (a look-alike substance that contains no drug) to evaluate this outcome. Participants will: * Receive either suzetrigine or placebo after cesarean delivery * Receive standard postoperative pain management, including acetaminophen, nonsteroidal anti-inflammatory drugs, and neuraxial morphine * Have opioid medications available as needed for breakthrough pain * Be followed during hospitalization and after discharge to assess pain, recovery, and medication use

Effects of S-ketamine on Perioperative Opioid Consumption

This study is a triple-blind randomized controlled trial conducted at a tertiary care hospital in Brussels. It investigates whether a single dose of S-ketamine can reduce opioid (morphine) consumption in the first 24 hours after elective laparoscopic gynecological surgery in relatively healthy adult patients (ASA 1-2). The goal is to assess S-ketamine's effectiveness within a standardized postoperative pain management protocol.

Preoperative Opioid Tapering Before Spine Surgery

This is a pilot study in which patients taking opioids chronically who are scheduled for spine surgery at least 4 weeks in advance will be randomly assigned to one of two groups: opioid tapering with education alone or opioid tapering with education plus cognitive behavioral therapy (CBT). The primary objective is to determine the proportion of each group that is successful in achieving their opioid tapering goals by the time of surgery.

The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery

The goal of this single-center, pragmatic, randomized, blinded, placebo-controlled trial is to evaluate the impact of intravenous (IV) lidocaine within the existing Enhanced Recovery After Surgery (ERAS)program on outcomes in patients after major non-cardiac surgery. The main questions the trial aims to answer are: The primary hypothesis is that utilization of IV lidocaine as part of a perioperative multimodal pain regimen will result in a reduction in hospital Case Mix Index-Adjusted Resource Length of Stay (CARLOS). The secondary hypotheses are that lidocaine infusion will result in a reduction in total inpatient opioid consumption (oral morphine milligram equivalents, oMMEs) and pain scores, and improved surgical outcomes (including return of bowel function, ileus, nausea, rapid responses called, surgical site infections, and ICU transfers), while also having minimal incidence of side effects (including double/blurry vision, tinnitus, sedation, and adverse events requiring early cessation).

Evaluation of the Postoperative Efficacy of Bilateral Lumbar Erector Spinae Plane Block (ESPB) in Patients Undergoing Lumbar Disc Herniation Repair Surgery

This prospective observational study aims to evaluate the efficacy of bilateral lumbar erector spinae plane (ESP) block in providing effective postoperative analgesia and its potential impact on early mobilization and length of hospital stay in patients undergoing surgical repair of lumbar disc herniation. Regional anesthesia techniques, particularly erector spinae plane blocks, have become an integral component of multimodal analgesia strategies in postoperative pain management. The ESP block has demonstrated effective analgesia across a wide spectrum of thoracic and abdominal surgeries and is increasingly utilized due to its ease of application and safety profile. By implementing multimodal analgesic techniques, this study seeks to achieve effective pain control, reduce opioid consumption and associated complications, facilitate early mobilization, decrease hospital length of stay, and enhance patient comfort.

Dexmedetomidine as an Adjuvant to Bupivacaine for Ultrasound-Guided External Oblique Intercostal Block

Effect of Adding Dexmedetomidine as Adjuvant toBupivacaine in Ultrasound Guided ExternalOblique Intercostal Plane Block in UpperAbdominal Cancer Surgery.

Intravenous Acetaminophen to Reduce Post-operative Opioid Consumption

Acetaminophen (Tylenol) is a commonly used medication after surgery to control pain. Tablets for oral use and suppositories for rectal use are the most frequently employed forms of acetaminophen after surgery. Intravenous (IV) acetaminophen is widely used in several countries but is not a standard medication for the adult population in Canada. It is mainly considered when it is impossible to take medication in tablet or suppository form. Opioids (Morphine, Hydromorphone, Oxycodone, etc.) are another class of medications commonly used after surgery for pain management. While they are generally very effective and stronger than acetaminophen or other pain relievers (e.g., ibuprofen/Advil), reducing their use is preferable, as they can cause various side effects such as nausea, dizziness, and dependence. IV acetaminophen may help control pain while also reducing opioid consumption. However, there are few high-quality scientific studies proving the benefits of IV acetaminophen compared to other forms, such as tablets or suppositories. Acetaminophen has been available in Canada for many years and has already been recommended for use in Quebec by the Institut national d'excellence en santé et services sociaux (INESSS) under certain conditions. This study aims to validate its benefits with clear data.