Management of Postoperative Pain After Total Knee Replacement.

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Knee Replacement Arthroplasty
• Intervention / Treatment: Drug: Nerve Block; Drug: Periarticular Injection

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nerve Block; Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.	Drug: Nerve Block; Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.; Other Names: Naropin
Active Comparator: Periarticular Injection; Injection combination prior to skin closure.	Drug: Periarticular Injection; 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.; Other Names: Naropin; Toradol; Adrenalin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mark J. Spangehl, M.D.
• Investigators: Principal Investigator: Mark J Spangehl, M.D., Mayo Clinic

Publications and helpful links

General Publications

• Spangehl MJ, Clarke HD, Hentz JG, Misra L, Blocher JL, Seamans DP. The Chitranjan Ranawat Award: Periarticular injections and femoral & sciatic blocks provide similar pain relief after TKA: a randomized clinical trial. Clin Orthop Relat Res. 2015 Jan;473(1):45-53. doi: 10.1007/s11999-014-3603-0.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 14, 2010
• First Submitted That Met QC Criteria: July 14, 2010
• First Posted (Estimate): July 15, 2010

Study Record Updates

• Last Update Posted (Estimate): November 5, 2014
• Last Update Submitted That Met QC Criteria: November 3, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 10-003312; UL1TR000135 (U.S. NIH Grant/Contract)