DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 analgesia

Pain 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017