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Completed

NCT Number: NCT01307202

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

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.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Total Knee Replacement

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

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

Other names: Neurontin

Placebo

Drug

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

Other names: Sugar pill

Primary outcomes

  1. Amount of morphine consumption

    Time frame: 2 years

Secondary outcomes

  1. Side effects

    Time frame: 2 years

    Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • St. Joseph's Healthcare Hamilton

Registry information

Official study title

Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Total Knee Arthroplasty

Acronym: TKR

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Mar 2, 2011
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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