The Volume-concentration Relationship of Analgesic Efficacy With Intra-capsular Local Anesthetic in Total Knee Arthroplasty: a Randomized, Double-blind, Cross-over Trial.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- postoperative pain
Study Overview
Brief Summary
In a randomized, double-blind, cross-over trial, 48 patients scheduled for total knee arthroplasty with placement of an intracapsular catheter will be randomized to receive bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL) or low volume/high concentration (10 mL, 10 mg/mL) 6 and 24 hours postoperatively, and pain will be assessed at rest and with mobilization for 2 hours after injections.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Scheduled for total knee arthroplasty
- •Able to give informed oral and written consent to participate
Exclusion Criteria
- •Treatment with opioids or steroids, rheumatoid arthritis or other immunological diseases
- •History of stroke or any neurological or psychiatric disease potentially influencing pain perception (e.g. depression, diabetic neuropathy etc.)
- •Allergies to any of the drugs administered.
Arms & Interventions
low volume local anesthetic
bolus injection of local anesthetic in low volume/high concentration (10 mL, 10 mg/mL)
Intervention: 10 mL ropivacaine 10 mg/mL (Drug)
high volume local anesthetic
bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL)
Intervention: 20 mL ropivacaine 5 mg/mL (Drug)
Outcomes
Primary Outcomes
postoperative pain
Time Frame: 32 hours postoperative
Secondary Outcomes
No secondary outcomes reported