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

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

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 Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: placebo; Drug: Pregabalin

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 Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo in capsule is prescribed to the patient 60 min prior to the surgery.	Drug: 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; Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.	Drug: Pregabalin; 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.; Other Names: Lyrica

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Analgesia	Time to first analgesia is recorded from IV PCA.	24 hours
Pain Scores on the Visual Analog Scale	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	24 hours
Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability	Measure sedation score by evaluate and observe; measure pruritus, PONV, dizziness, visual disturbance using questionnaire	24 hours
Number of Patients Evaluating Their Satisfaction	Using four-point scale to evaluate patient satisfaction. Patients indicated if their satisfaction was Unsatisfied, Less Satisfied, Moderately Satisfied, or Good Satisfied.	24 hours

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Taniga Kiatchai, MD, Mahidol University

Publications and helpful links

General 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. No abstract available.
• 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. No abstract available.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: October 31, 2014
• First Submitted That Met QC Criteria: November 4, 2014
• First Posted (Estimate): November 6, 2014

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: pregabalin; abdominal hysterectomy; postoperative pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: Si594/2014