Clinical trial NCT01307202: Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment
Official title: Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Total Knee Replacement
Keywords: knee
arthroplasty
postoperative pain
gabapentin
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2011-03-02
Enrollment: 101
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Amount of morphine consumption
timeFrame: 2 years
Secondary outcomes:
measure: Side effects
timeFrame: 2 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Manyat Nantha-Aree, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.