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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307202
• Other study ID #: 07-215-TKR
• Status: Completed
• Phase: N/A
• First received: February 28, 2011
• Last updated: November 19, 2014
• Start date: October 2007
• Est. completion date: February 2011

Study information

• Verified date: November 2014
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain
• Total Knee Replacement

Intervention

Drug:
• Gabapentin
600mg of Gabapentin will be given orally preoperatively and 200mg for 3 times a day after surgery for 3 days
• Placebo
Placebo will match the the gabapentin pill and will be given orally.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of morphine consumption		2 years	No
Secondary	Side effects	Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness	2 years	No