Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study (MOBILE)

June 4, 2026 updated by: McMaster University

Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Primary Hip Arthroplasty

Total hip arthroplasty is amongst the most painful procedures postoperatively, and pain management can be a challenge. Different measures have been introduced to manage severe postoperative pain in these patients. Previous studies have investigated gabapentin in acute postoperative pain and demonstrated reduced postoperative pain, postoperative morphine consumption, morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct has yet to be investigated for total joint arthroplasty patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was submitted to Health Canada and has received the letter of no objection. A randomized, double-blind, placebo-controlled trial will be conducted. The randomization scheme will be prepared and done by the pharmacy department at McMaster University. Ninety patients undergoing primary hip arthroplasty will be recruited from the preoperative clinic. Forty-five patients in each population will be allocated to a gabapentin group and the other forty-five patients will be allocated to a placebo group.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Hamilton Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • participants aged 19-90
  • elective single joint, primary total hip arthroplasty
  • use of PCA with morphine for postoperative pain control has been discussed and agreed upon between patient and anesthetist

Exclusion Criteria:

  • bilateral total hip arthroplasty
  • revision hip arthroplasty
  • underlying diseases of epilepsy, seizure, or chronic pain syndrome
  • active gastrointestinal bleeding within the last 6 months
  • history of non-steroidal anti-inflammatory drug (NSAID) induced asthma
  • known or suspected history of drug or alcohol abuse
  • participate currently takes gabapentin or pregabalin for any reason
  • participant currently takes pain medication that is more potency than codeine or oxycodone (morphine, hydromorphone, meperidine, methadone, fentanyl, including any long acting narcotics)
  • known allergy to study medications: gabapentin, morphine, NSAID, acetaminophen
  • unable to tolerate morphine
  • liver impairments
  • kidney impairment or calculated creatinine clearance by Cockcroft-Gault formula is <=60ml/min
  • pregnancy or breast-feeding
  • participant currently receives associated worker's compensation benefits (WSIB)
  • participant unable or unwilling to give written or informed consent
  • unable to use PCA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Half the patients will be randomized to placebo
Other Names:
  • Sugar pill
Experimental: Gabapentin
600mg of gabapentin will be given orally two hours preoperatively and 200mg for 3 times a day after surgery for three days.
Drug: Gabapentin
600mg gabapentin given 2 hrs preoperatively and 200mg three times a day after surgery for 3 days
Other Names:
  • Neurontin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of morphine consumption
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: Two years
Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness
Two years
Pain scores
Time Frame: Two years
Pain score at rest in PACU, POD1, POD2, POD3 Pain score upon passive movement in PACU, POD1, POD2, POD3 Pain score with weighbearing on POD1, POD2, POD3
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Manyat Nantha-Aree, MD, Hamilton Health Sciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 27, 2009

First Posted (Estimated)

April 28, 2009

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-215-THR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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