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Clinical Trials/NCT02285010
NCT02285010
Completed
Phase 4

Effects of Pre-operative Oral Pregabalin on Post Operative Morphine Consumption After Abdominal Hysterectomy With/Without Salpingo-oophorectomy Under Spinal Anesthesia With Intrathecal Morphine

Mahidol University1 site in 1 country125 target enrollmentNovember 2014

Overview

Phase
Phase 4
Intervention
placebo
Conditions
Post Operative Pain
Sponsor
Mahidol University
Enrollment
125
Locations
1
Primary Endpoint
Post Operative Morphine Consumption
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
August 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ASA classification 1-2 undergoing abdominal hysterectomy with/without salpingo-oophorectomy under spinal anesthesia with intrathecal morphine
  • Patient can use patient-controlled analgesia (IV PCA)

Exclusion Criteria

  • History of drug allergy to gabapentinoid and related drug
  • History of regular analgesic drug use, psychiatric drug usage, drug abuse, alcohol addiction or chronic pain patient
  • Renal disease (Creatinine Clearance \< 60), Liver disease, Seizure disorder and Psychiatric disorder

Arms & Interventions

Placebo

Placebo in capsule is prescribed to the patient 60 min prior to the surgery.

Intervention: placebo

Pregabalin

Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.

Intervention: Pregabalin

Outcomes

Primary Outcomes

Post Operative Morphine Consumption

Time Frame: 6, 12, and 24 hours after operation

Cumulative morphine consumption in the first 24 hours is recorded from IV PCA

Secondary Outcomes

  • Time to First Analgesia(24 hours)
  • Pain Scores on the Visual Analog Scale(24 hours)
  • Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability(24 hours)
  • Number of Patients Evaluating Their Satisfaction(24 hours)

Study Sites (1)

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