Management of Postoperative Pain After Total Knee Replacement.

Study Overview
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Brief Summary
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The purpose of this study is to compare two methods of postoperative pain management in patients undergoing total knee replacement.

Detailed Description
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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.

Official Title
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Prospective Randomized Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Postoperative Pain After Total Knee Replacement.

Conditions
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Postoperative Pain, Knee Replacement Arthroplasty

Intervention / Treatment
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* Drug: Nerve Block
* Drug: Periarticular Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nerve Block<br>Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. | Drug: Nerve Block<br>* Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.<br>* Other names: Naropin;|
| Active Comparator: Periarticular Injection<br>Injection combination prior to skin closure. | Drug: Periarticular Injection<br>* Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.<br>* Other names: Toradol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Operative Pain | Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain). | Afternoon on post-operative Day 1, approximately 14:00 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment) | Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain). | Afternoon on post-operative Day 1, approximately 14:00 | 
| Narcotic Use | Use of additional narcotic medications (as needed), measured in morphine equivalents. | Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2 | 
| Straight-leg Raise | Post-operative quadriceps function was measured by the number of participants who could perform a straight-leg raise. | Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon | 
| Length of Stay in Hospital | Length of stay data were calculated from the medical record. | Approximately 2 days after surgery | 
| Number of Subjects Who Experienced Neurological Changes Postoperatively | Participants were questioned at the 6 weeks follow-up visit regarding any neurological changes that were not present preoperatively. | 6 weeks postoperative |