Prospective Randomized Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Postoperative Pain After Total Knee Replacement.
Overview
- Phase
- Phase 4
- Intervention
- Nerve Block
- Conditions
- Postoperative Pain
- Sponsor
- Mark J. Spangehl, M.D.
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Post-Operative Pain
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to compare two methods of postoperative pain management in patients undergoing total knee replacement.
Detailed Description
Patients undergoing total knee replacement will be assigned at random to receive one of two methods of postoperative pain management. Patients assigned to nerve block will receive regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block. Patients assigned to periarticular injection will receive periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Additionally, all patients will be given a standardized combination of oral analgesic medications preoperatively and postoperatively. All patients will receive a posterior stabilized total knee replacement through an medial parapatellar approach.
Investigators
Mark J. Spangehl, M.D.
Associate Professor of Orthopedics
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Unilateral primary total knee replacement.
- •Weight 50-125 kg.
- •Age 18-79 years.
- •Intact neurological exam to the surgical lower extremity.
- •Cognitively intact with ability to sign informed consent.
Exclusion Criteria
- •Renal insufficiency with creatinine \>1.5 mg/dL.
- •Allergy to medication used in the study.
- •Using narcotic medication prior to surgery (morphine equivalents \>=20 mg/day for \>7 days.)
- •Prior open knee surgery with regional anesthesia or periarticular injection for post-operative pain management.
Arms & Interventions
Nerve Block
Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.
Intervention: Nerve Block
Periarticular Injection
Injection combination prior to skin closure.
Intervention: Periarticular Injection
Outcomes
Primary Outcomes
Post-Operative Pain
Time Frame: Afternoon on post-operative Day 1, approximately 14:00
Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).
Secondary Outcomes
- Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)(Afternoon on post-operative Day 1, approximately 14:00)
- Narcotic Use(Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2)
- Straight-leg Raise(Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon)
- Length of Stay in Hospital(Approximately 2 days after surgery)
- Number of Subjects Who Experienced Neurological Changes Postoperatively(6 weeks postoperative)