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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Postoperative Pain Total Hip Replacement
Intervention	Drug: Gabapentin Other: Placebo
Phase	N/A
Sponsor	Hamilton Health Sciences Corporation
Responsible Party	McMaster University
ClinicalTrials.gov Identifier	NCT00889148
First Received	April 27, 2009
Last Updated	February 28, 2011
Last verified	April 2009

Tracking Information[ + expand ][ + ]

First Received Date	April 27, 2009
Last Updated Date	February 28, 2011
Start Date	October 2007
Estimated Primary Completion Date	February 2011
Current Primary Outcome Measures	Amount of morphine consumption [Time Frame: Two years] [Designated as safety issue: No]
Current Secondary Outcome Measures	Side effects [Time Frame: Two years] [Designated as safety issue: No]Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness Pain scores [Time Frame: Two years] [Designated as safety issue: No]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

Descriptive Information[ + expand ][ + ]

Brief Title	Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study
Official Title	Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Primary Hip Arthroplasty
Brief 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.
Detailed 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.
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	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 Names: NeurontinOther: Placebo Half the patients will be randomized to placebo Other Names: Sugar pill
Study Arm (s)	Experimental: Gabapentin 600mg of gabapentin will be given orally two hours preoperatively and 200mg for 3 times a day after surgery for three days. Placebo Comparator: Placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	103
Estimated Completion Date	February 2011
Estimated Primary Completion Date	February 2011
Eligibility Criteria	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
Gender	Both
Ages	19 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Canada

Administrative Information[ + expand ][ + ]

NCT Number	NCT00889148
Other Study ID Numbers	07-215-THR
Has Data Monitoring Committee	No
Information Provided By	McMaster University
Study Sponsor	Hamilton Health Sciences Corporation
Collaborators	Not Provided
Investigators	Principal Investigator: Manyat Nantha-Aree, MD Hamilton Health Sciences Corporation
Verification Date	April 2009

Locations[ + expand ][ + ]