Clinical Trials Logo

Clinical Trial Summary

Pain management after gynecological surgeries is essential for early mobilization of the patient, decrease postoperative complication and hospital stay. The use of opioids is associated with adverse effects such as nausea, vomiting, ileus, pruritus, sedation and respiratory depression. Previous studies stated that pregabalin has been used to reduce pre-operative anxiety, acute postoperative pain, postoperative opioid requirements, postoperative nausea, vomiting and postoperative delirium. The most effective dose of pregabalin to relief postoperative pain with least side effect is still under trial. In this study we will compare between two different doses of pregabalin when given as oral premedication in patients undergoing gynecological surgeries under spinal anesthesia regarding postoperative pain in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects.


Clinical Trial Description

Postoperative pain, nausea and vomiting continue to be one of the most common and unpleasant complications after surgery. The traditional pain treatment with opioids alone is not adequate any more. To optimize pain treatment and postoperative outcome, new analgesics and new combination of already existing analgesics are searched for. Pain after gynecological surgery usually severe. Uncontrolled acute post-operative pain is associated with dissatisfaction, post-operative complications and considered as a strong risk factor for development of chronic pain. An enhanced recovery pathway for gynecological surgery must include a strategy to effectively control post-operative pain and allow attainment of other Enhanced Recovery After Surgery (ERAS) targets such as early mobilization and return to oral diet whilst reducing the need for opiates. Beyond increasing the risk of developing opioid use disorder, perioperative opioid consumption may produce undesirable side effects such as nausea, vomiting, constipation, ileus, pruritus, altered mental status, urinary retention, respiratory complications and increased length of hospital stay. While many of these side effects are frustrating to patient in the immediate postoperative period, the most dangerous effects are those that affect the respiratory system such as opioid-induced respiratory depression (ORD) which consider as a significant cause of brain damage and death in the postoperative period. Opioid reduction strategies prove useful for decreasing total opioid dose and, in turn, their associated adverse effects. Such strategies may include adjuvant non opioid analgesics such as α-2 agonists, gabapentinoids and N-methyl-D-aspartate receptor agonists as well as local, regional or neuraxial anesthesia and modification of surgical technique where possible for operative patients. Pregabalin is a new synthetic molecule and a structural derivative of the inhibitory neurotransmitter gamma-amino butyric acid. It is a α2-δ ligand that has analgesic, anticonvulsant, anxiolytic and sleep-modulating activities. Pregabalin binds potently to the α2-δ subunit of calcium channels, resulting in a reduction in the release of several neurotransmitters including glutamate, noradrenaline, serotonin, dopamine and substance P. Pregabalin could reduce the hyperexcitability of dorsal horn neurons induced by tissue damage; therefore it may be useful in the postsurgical pain prevention. In 2015, a meta-analysis published in British Medical Journal (BMJ) suggested that pregabalin could improve postoperative analgesia and opioid-related adverse effects namely, vomiting and visual disturbances after surgery. However, the use of the pregabalin for acute postoperative pain is still under trial though widely reported. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04708353
Study type Interventional
Source Zagazig University
Contact Asmaa M Galal, MD
Phone 01271550089
Email asmaa_galal79@yahoo.com
Status Recruiting
Phase N/A
Start date August 20, 2020
Completion date November 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05509244 - Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Laparoscopic Gynecology Surgery N/A
Recruiting NCT04963751 - ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling N/A
Recruiting NCT05125692 - Vaginal Repair of Post Cesarean Istmocele N/A
Active, not recruiting NCT04171297 - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Completed NCT06011928 - MOPEXE and RE in Treating Dysmenorrhea N/A
Not yet recruiting NCT05974995 - Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer N/A
Completed NCT04839263 - Fast-track in Minimally Invasive Gynaecology N/A
Completed NCT04498208 - Immune Modulation by Enhanced vs Standard Prehabilitation Program Before Major Surgery N/A
Completed NCT04642118 - Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery N/A
Completed NCT03820115 - Elastic Abdominal Binder After Open Abdominal Surgery for Benign Gynecologic Conditions N/A
Recruiting NCT03327506 - Preoperative Hypnosis Versus Premedication in Gynecological Surgery Phase 4
Recruiting NCT02957500 - To Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) N/A
Completed NCT02476799 - Analgesic Effects of US Bilateral Rectus Sheath Block for Laparoscopic GY Surgery N/A
Recruiting NCT06425484 - The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation. N/A
Completed NCT02450084 - Ultrasound-guided Bilateral Rectus Sheath Block for Robotic Single-port Gynecologic Surgery N/A
Completed NCT03916445 - Resilience and Quality of Life in Patients With Gynaecological Carcinomas and Chronic Gynaecological Diseases
Completed NCT05325619 - Evaluation of the Rate of Consultations in Gynecological Emergencies Under "Non-urgent" Management
Not yet recruiting NCT05781581 - A Retrospective Cohort Study for Main Postoperative Complications After SARS-CoV-2 Infection
Recruiting NCT03427840 - Superior Hypogastric Plexus Blockade in Laparoscopic Hysterectomy
Completed NCT03884244 - Postoperative Chewing Gum and Gynecological Laparoscopic Surgery N/A