Effect of Pregabalin on Post Operative Pain in Abdominal Hysterectomy Under Spinal Anesthesia With Intrathecal Morphine
Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Operative Pain
Intervention: placebo (Drug); Pregabalin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Mahidol University Official(s) and/or principal investigator(s): Taniga Kiatchai, MD, Principal Investigator, Affiliation: Mahidol University
Overall contact: Taniga Kiatchai, MD, Phone: 66(81) 814-0790, Email: taniga@gmail.com
Summary
This study aims to compare the effect of pre-operative oral pregabalin on post operative
morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.
Clinical Details
Official title: Effects of Pre-operative Oral Pregabalin on Post Operative Morphine Consumption After Abdominal Hysterectomy With/Without Salpingo-oophorectomy Under Spinal Anesthesia With Intrathecal Morphine
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Post Operative Morphine Consumption
Secondary outcome: Time to first analgesiaPain Scores on the Visual Analog Scale Numbers of Participants with Adverse Events as a Measure of Safety and Tolerability Patient satisfaction
Detailed description:
The participants are randomized into two groups by computer randomization. The patient
undergo spinal anesthesia with 0. 5% Heavy bupivacaine with morphine 0. 2 mg. IV PCA morphine
is initiate in the post-anesthetic care unit. We compare post operative morphine
consumption in the first 24 hours, time to first analgesia, adverse event, and patient
satisfaction.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. ASA classification 1-2 undergoing abdominal hysterectomy with/without
salpingo-oophorectomy under spinal anesthesia with intrathecal morphine
2. Patient can use patient-controlled analgesia (IV PCA)
Exclusion Criteria:
1. History of drug allergy to gabapentinoid and related drug
2. History of regular analgesic drug use, psychiatric drug usage, drug abuse, alcohol
addiction or chronic pain patient
3. Renal disease (Creatinine Clearance < 60), Liver disease, Seizure disorder and
Psychiatric disorder
Locations and Contacts
Taniga Kiatchai, MD, Phone: 66(81) 814-0790, Email: taniga@gmail.com
Faculty of Medicine Siriraj Hospital, Bangkoknoi, Bangkok 10700, Thailand; Recruiting Taniga Kiatchai, MD, Phone: 66(2)4197990, Email: taniga@gmail.com
Additional Information
Related publications: Schmidt PC, Ruchelli G, Mackey SC, Carroll IR. Perioperative gabapentinoids: choice of agent, dose, timing, and effects on chronic postsurgical pain. Anesthesiology. 2013 Nov;119(5):1215-21. doi: 10.1097/ALN.0b013e3182a9a896. Review. Sahgal N, Banerjee A. Efficacy of pregabalin in acute postoperative pain: a meta-analysis. Br J Anaesth. 2011 Aug;107(2):274; author reply 275. doi: 10.1093/bja/aer207. Engelman E, Cateloy F. Efficacy and safety of perioperative pregabalin for post-operative pain: a meta-analysis of randomized-controlled trials. Acta Anaesthesiol Scand. 2011 Sep;55(8):927-43. doi: 10.1111/j.1399-6576.2011.02471.x. Epub 2011 Jun 27. Review.
Starting date: November 2014
Last updated: November 24, 2014
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