Postoperative Pain, Total Hip Replacement
Conditions
Keywords
hip, arthroplasty, postoperative pain, gabapentin
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.
Interventions
DRUGGabapentin
600mg gabapentin given 2 hrs preoperatively and 200mg three times a day after surgery for 3 days
OTHERPlacebo
Half the patients will be randomized to placebo
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of morphine consumption | Two years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | Two years | Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness |
| Pain scores | Two years | 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 |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORManyat Nantha-Aree, MD
Hamilton Health Sciences Corporation
Outcome results
None listed