Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study

Postoperative Pain Clinical Trial

— MOBILE  

Official title:

Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Primary Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889148
• Other study ID #: 07-215-THR
• Status: Completed
• Phase: N/A
• First received: April 27, 2009
• Last updated: February 28, 2011
• Start date: October 2007
• Est. completion date: February 2011

Study information

• Verified date: April 2009
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Total hip 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 in these patients. Previous studies have investigated gabapentin in acute postoperative pain and demonstrated reduced postoperative pain, postoperative morphine consumption, morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct has yet to be investigated for total joint arthroplasty patients.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• 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 hip arthroplasty

• use of PCA with morphine for postoperative pain control has been discussed and agreed upon between patient and anesthetist

Exclusion Criteria:

• bilateral total hip arthroplasty

• revision hip arthroplasty

• underlying diseases 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

• participate 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
• Postoperative Pain
• Total Hip Replacement

Intervention

Drug:
• Gabapentin
600mg gabapentin given 2 hrs preoperatively and 200mg three times a day after surgery for 3 days

Other:
• Placebo
Half the patients will be randomized to placebo

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of morphine consumption		Two years	No
Secondary	Side effects	Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness	Two years	No
Secondary	Pain scores	Pain score at rest in PACU, POD1, POD2, POD3 Pain score upon passive movement in PACU, POD1, POD2, POD3 Pain score with weighbearing on POD1, POD2, POD3	Two years	No