CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 125 enrolled
Drug / intervention
placebo +1 moredrug
Likely dose
placebo 15 mLfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02285010
NCT02285010Phase 4Completed

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 University·interventional·Posted Nov 6, 2014·Updated Mar 15, 2019

In Brief

A Phase 4 clinical trial evaluating placebo and Pregabalin for Post Operative Pain. Completed, enrolled 125 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesThailand
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 6, 2014
Enrollment StartNov 1, 2014
Primary CompletionJan 1, 2016
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.7 years ago

Interventions

placebodrug

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.

Pregabalindrug

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.