Effect of Pregabalin on Post Operative Pain in Abdominal Hysterectomy Under Spinal Anesthesia With Intrathecal Morphine

Phase 4

Completed

• Conditions: Post Operative Pain
• Interventions: Drug: placebo; Drug: Pregabalin

• Registration Number: NCT02285010
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study First Submitted: 2014-10-31
• Study Start: 2014-11
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-06
• Primary Completion: 2016-01
• Study Completion: 2016-08
• Results First Submitted: 2017-10-15
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-27
• Last Update Submitted: 2018-11-27
• Results First Posted: 2019-03-15
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
Pregabalin	Pregabalin	Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.

Primary Outcome Measures

Name	Time	Method
Post Operative Morphine Consumption	6, 12, and 24 hours after operation	Cumulative morphine consumption in the first 24 hours is recorded from IV PCA

Secondary Outcome Measures

Name	Time	Method
Time to First Analgesia	24 hours	Time to first analgesia is recorded from IV PCA.
Pain Scores on the Visual Analog Scale	24 hours	Pain score is evaluated by nurses using Numerical Rating Scale (NRS); Minimum score 0 (no pain), Maximum score 10 (worst imaginable pain), lower scores mean a better outcome
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability	24 hours	Measure sedation score by evaluate and observe; measure pruritus, PONV, dizziness, visual disturbance using questionnaire
Number of Patients Evaluating Their Satisfaction	24 hours	Using four-point scale to evaluate patient satisfaction. Patients indicated if their satisfaction was Unsatisfied, Less Satisfied, Moderately Satisfied, or Good Satisfied.

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkoknoi, Bangkok, Thailand