Management of Postoperative Pain After Total Knee Replacement.

Mark J. Spangehl, M.D.160 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Postoperative Pain Knee Replacement Arthroplasty

Interventions

Nerve BlockDRUG

Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.

Periarticular InjectionDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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).

Time frame: Afternoon on post-operative Day 1, approximately 14:00

Secondary Outcomes

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).

Time frame: Afternoon on post-operative Day 1, approximately 14:00

Narcotic Use

Use of additional narcotic medications (as needed), measured in morphine equivalents.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 6 weeks postoperative

Data from ClinicalTrials.gov

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