Morphine Consumption in Joint Replacement Patients, With... | NCT01307202

Studies
Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment

NCT01307202

Sponsor

McMaster University

Status

Completed

Last Update Posted

Jun 10, 2026Actual

Enrollment

101Actual

Phase

Not Applicable

Conditions

Post Operative Pain
Total Knee 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 2007Actual

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Feb 28, 2011

First Submission Date that Met QC Criteria

Mar 1, 2011

First Posted Date

Mar 2, 2011Estimated

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 8, 2026

Last Update Posted Date

Jun 10, 2026Actual

Name	Class
St. Joseph's Healthcare Hamilton	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 knee 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 int hese patients. Previous studies have investigated gabapentin in acute postoperative pain and demonstrated reducted pain, postoperative morphine consumption, morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct has yet to be investigated in total joint arthroplasty patients.

Detailed Description

The study was submitted to Health Canada and received the letter of no objection. A randomized, double-blind, placebo-controlled study. The randomization scheme will be prepared and will be done by the pharmacy department at McMaster University. Ninety patients undergoing primary knee 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 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

101Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gabapentin	Experimental	Gabapentin 600 mg will be given per oral two hours preoperatively and 200 mg three times daily after surgery (600 mg/day).	Drug: Gabapentin
Placebo	Placebo Comparator	Placebo will match the the gabapentin pill and will be given orally.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gabapentin	Drug	600mg of Gabapentin will be given orally preoperatively and 200mg for 3 times a day after surgery for 3 days	Gabapentin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of morphine consumption		2 years

Secondary Outcomes

Measure	Description	Time Frame
Side effects	Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

bilateral total knee arthroplasty
revision knee arthroplasty
underlying disease 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
participant 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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25772701	Derived	Paul JE, Nantha-Aree M, Buckley N, Shahzad U, Cheng J, Thabane L, Tidy A, DeBeer J, Winemaker M, Wismer D, Punthakee D, Avram V. Randomized controlled trial of gabapentin as an adjunct to perioperative analgesia in total hip arthroplasty patients. Can J Anaesth. 2015 May;62(5):476-84. doi: 10.1007/s12630-014-0310-y. Epub 2015 Mar 14.
23479393

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

ID	Term
D000077206	Gabapentin
D000073893	Sugars

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