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

NCT02285010 | Completed Phase 4 Results

• 1 other identifier: Si594/2014
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

pregabalin; postoperative pain; abdominal hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Pregabalin

ACTIVE COMPARATOR

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

Drug: Pregabalin

Interventions

placebo DRUG

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.

Placebo

Pregabalin DRUG

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.

Also known as: Lyrica

Pregabalin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (3)

• 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.

  PMID: 24051389 BACKGROUND

• 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.

  PMID: 21757554 BACKGROUND

• 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.

  PMID: 21707548 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

1. Did not perform intention-to-treat analysis. When the treatment plan was changed, the patient was withdrawn from the study. 2. Single dose pre-operation instead of multi-dose post-operation. 3. Homogeneity of population

Results Point of Contact

• Title: Dr.Taniga Kiatchai
• Organization: Mahidol University

taniga@gmail.com

+66-2-419-7990

Study Officials

• Taniga Kiatchai, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 6, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 15, 2019
• Results First Posted: March 15, 2019

Record last verified: 2018-11

Locations

TH (1)