Morphine COnsumption in Joint Replacement Patients, With... | NCT00889148

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

NCT00889148

Sponsor

McMaster University

Status

Completed

Last Update Posted

Jun 8, 2026Actual

Enrollment

103Actual

Phase

Not Applicable

Conditions

Postoperative Pain
Total Hip Replacement

Interventions

Gabapentin
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Apr 27, 2009

First Submission Date that Met QC Criteria

Apr 27, 2009

First Posted Date

Apr 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2026

Last Update Posted Date

Jun 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gabapentin	Experimental	600mg of gabapentin will be given orally two hours preoperatively and 200mg for 3 times a day after surgery for three days.	Drug: Gabapentin
Placebo	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gabapentin	Drug	600mg gabapentin given 2 hrs preoperatively and 200mg three times a day after surgery for 3 days	Gabapentin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of morphine consumption		Two years

Secondary Outcomes

Measure	Description	Time Frame
Side effects	Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness	Two years
Pain scores	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Manyat Nantha-Aree, MD	Hamilton Health Sciences Corporation	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hamilton Health Sciences		Hamilton	Ontario	L8N 3Z5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D000588	Amines
D009930	Organic Chemicals
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates

ID	Term
D000077206	Gabapentin
D000073893	Sugars