CClinicalTrials.gg
CompletedNCT01307202TKRUpdated Jun 10, 2026

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

An interventional study of Gabapentin and Placebo in Post Operative Pain and Total Knee Replacement, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 19 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by McMaster University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 4 months after the study started (first participant enrolled Oct 2007, registered Feb 2011).
Phase
Not applicable
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
19 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Post Operative Pain
  • Total Knee Replacement

Browse trials for

Keywords

  • knee
  • arthroplasty
  • postoperative pain
  • gabapentin
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 101 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
101 participants (actual)

Study arms

  • Experimental
    Gabapentin

    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 comparator
    Placebo

    Placebo will match the the gabapentin pill and will be given orally.

    Drug: Placebo

Interventions

  • DrugGabapentin

    600mg of Gabapentin will be given orally preoperatively and 200mg for 3 times a day after surgery for 3 days

    Also known as: Neurontin

  • DrugPlacebo

    Placebo will match the the gabapentin pill and will be given orally.

    Also known as: Sugar pill

06

What researchers measure

Primary outcomes

  1. Amount of morphine consumption

    Time frame: 2 years

Secondary outcomes

  1. Side effects

    Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness

    Time frame: 2 years

07

Study locations

1 site
  • Hamilton Health Sciences
    Hamilton, Ontario L8N 3Z5, Canada
08

References and documents

Publications

  • 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. PubMed 25772701 ↗
  • Paul JE, Nantha-Aree M, Buckley N, Cheng J, Thabane L, Tidy A, DeBeer J, Winemaker M, Wismer D, Punthakee D, Avram V. Gabapentin does not improve multimodal analgesia outcomes for total knee arthroplasty: a randomized controlled trial. Can J Anaesth. 2013 May;60(5):423-31. doi: 10.1007/s12630-013-9902-1. Epub 2013 Mar 12. PubMed 23479393 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01307202
Lead sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton
Responsible party
Sponsor
First posted
Mar 2, 2011
Start date
Oct 2007
Primary completion
Feb 2011
Completion
Feb 2011
Last update
Jun 10, 2026

Study contacts

Manyat Nantha-Aree, MD
principal investigator · Hamilton Health Sciences Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion