Management of Postoperative Pain After Total Knee Replacement.

Phase 4

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Periarticular Injection	Periarticular Injection	Injection combination prior to skin closure.
Nerve Block	Nerve Block	Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.

Primary Outcome Measures

Name	Time	Method
Post-Operative Pain	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 Outcome Measures

Name	Time	Method
Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)	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).
Narcotic Use	Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2	Use of additional narcotic medications (as needed), measured in morphine equivalents.
Straight-leg Raise	Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon	Post-operative quadriceps function was measured by the number of participants who could perform a straight-leg raise.
Length of Stay in Hospital	Approximately 2 days after surgery	Length of stay data were calculated from the medical record.
Number of Subjects Who Experienced Neurological Changes Postoperatively	6 weeks postoperative	Participants were questioned at the 6 weeks follow-up visit regarding any neurological changes that were not present preoperatively.