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

NCT01307202 | Completed

• 1 other identifier: 07-215-TKR
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Operative Pain; Total Knee Replacement

Keywords

knee; arthroplasty; postoperative pain; gabapentin

Outcome Measures

Primary Outcomes (1)

• Amount of morphine consumption

  2 years

Secondary Outcomes (1)

• Side effects

  2 years

Study Arms (2)

Gabapentin

EXPERIMENTAL

Gabapentin 600 mg will be given per oral two hours preoperatively and 200 mg three times daily after surgery (600 mg/day).

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

Placebo will match the the gabapentin pill and will be given orally.

Drug: Placebo

Interventions

Gabapentin DRUG

600mg of Gabapentin will be given orally preoperatively and 200mg for 3 times a day after surgery for 3 days

Also known as: Neurontin

Gabapentin

Placebo DRUG

Placebo will match the the gabapentin pill and will be given orally.

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (2)

• Paul JE, Nantha-Aree M, Buckley N, Shahzad U, Cheng J, Thabane L, Tidy A, DeBeer J, Winemaker M, Wismer D, Punthakee D, Avram V. Randomized controlled trial of gabapentin as an adjunct to perioperative analgesia in total hip arthroplasty patients. Can J Anaesth. 2015 May;62(5):476-84. doi: 10.1007/s12630-014-0310-y. Epub 2015 Mar 14.

  PMID: 25772701 DERIVED

• Paul JE, Nantha-Aree M, Buckley N, Cheng J, Thabane L, Tidy A, DeBeer J, Winemaker M, Wismer D, Punthakee D, Avram V. Gabapentin does not improve multimodal analgesia outcomes for total knee arthroplasty: a randomized controlled trial. Can J Anaesth. 2013 May;60(5):423-31. doi: 10.1007/s12630-013-9902-1. Epub 2013 Mar 12.

  PMID: 23479393 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin; Sugars

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Carbohydrates

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 2, 2011
• Study Start: October 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: November 20, 2014

Record last verified: 2014-11

Locations

CA (1)