Overview

This trial is active, not recruiting.

Condition post operative pain
Treatments placebo, pregabalin
Phase phase 4
Sponsor Mahidol University
Start date November 2014
End date May 2016
Trial size 125 participants
Trial identifier NCT02285010, Si594/2014

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
placebo
Placebo in capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
(Active Comparator)
Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
pregabalin Lyrica
Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.

Primary Outcomes

Measure
Post Operative Morphine Consumption
time frame: 24 hours

Secondary Outcomes

Measure
Time to first analgesia
time frame: 24 hours
Pain Scores on the Visual Analog Scale
time frame: 24 hours
Numbers of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: 24 hours
Patient satisfaction
time frame: 24 hours

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

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
Principal investigator Taniga Kiatchai, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Mahidol University.