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

Primary Purpose

Postoperative Pain, Total Hip Replacement

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring hip, arthroplasty, postoperative pain, gabapentin

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamilton Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gabapentin

Placebo

Arm Description

600mg of gabapentin will be given orally two hours preoperatively and 200mg for 3 times a day after surgery for three days.

Outcomes

Primary Outcome Measures

Amount of morphine consumption

Secondary Outcome Measures

Side effects
Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness
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

Full Information

First Posted
April 27, 2009
Last Updated
February 28, 2011
Sponsor
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00889148
Brief Title
Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study
Acronym
MOBILE
Official Title
Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Primary Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Total Hip Replacement
Keywords
hip, arthroplasty, postoperative pain, gabapentin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
600mg of gabapentin will be given orally two hours preoperatively and 200mg for 3 times a day after surgery for three days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin
Intervention Description
600mg gabapentin given 2 hrs preoperatively and 200mg three times a day after surgery for 3 days
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Half the patients will be randomized to placebo
Primary Outcome Measure Information:
Title
Amount of morphine consumption
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Side effects
Description
Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness
Time Frame
Two years
Title
Pain scores
Description
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
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manyat Nantha-Aree, MD
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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