NCT00889148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 2, 2011

Status Verified

April 1, 2009

Enrollment Period

3.3 years

First QC Date

April 27, 2009

Last Update Submit

February 28, 2011

Conditions

Postoperative PainTotal Hip Replacement

Keywords

hiparthroplastypostoperative paingabapentin

Outcome Measures

Primary Outcomes (1)

  • Amount of morphine consumption

    Two years

Secondary Outcomes (2)

  • Side effects

    Two years

  • Pain scores

    Two years

Study Arms (2)

Gabapentin

EXPERIMENTAL

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

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

GabapentinDRUG

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

Also known as: Neurontin
Gabapentin
PlaceboOTHER

Half the patients will be randomized to placebo

Also known as: Sugar pill
Placebo

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

GabapentinSugars

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and ProteinsCarbohydrates

Study Officials

  • Manyat Nantha-Aree, MD

    Hamilton Health Sciences Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 28, 2009

Study Start

October 1, 2007

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 2, 2011

Record last verified: 2009-04

Locations

CA(1)