Overview

This trial is active, not recruiting.

Conditions osteoarthritis, pain
Treatments exparel, femoral nerve block bupivacaine, toradol, morphine sulfate
Phase phase 3
Sponsor The New England Baptist Hospital
Start date January 2014
End date February 2017
Trial size 312 participants
Trial identifier NCT02473198, 463360

Summary

The main objective of the study is to determine if intrarticular injection with liposomal bupivicaine (Exparel) provides better postoperative pain relief and functional outcome following total knee replacement (TKR) than the current standard New England Baptist Hospital regimen of femoral nerve block combined with intraarticular injection of a standard bupivicaine solution.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
In group1 (standard group) all patients receive the standard current perioperative pain management protocol for TKR. The patient will then undergo an ultrasound guided femoral nerve block with bupivacaine 0.25% 20 cc. Intraoperatively prior to cementing of the TKR, patients will also receive a local anesthetic injection of a mixture of 30cc 0.25% bupivicaine with epinephrine, 30mg of toradol and 10 mg of morphine sulfate into the posterior capsule of the knee joint. Postoperatively patients will receive narcotic pain medication on a PRN basis.
femoral nerve block bupivacaine Bupivacaine
The patient will then undergo an ultrasound guided femoral nerve block in the preoperative area with bupivacaine 0.25% 20 cc. All patients will undergo unilateral TKR using a medial parapatellar approach. Intraoperatively prior to cementing of the TKR, patients will also receive a local anesthetic injection of a mixture of 30cc 0.25% bupivicaine with epinephrine, 30mg of toradol and 10 mg of morphine sulfate into the posterior capsule of the knee joint.
(Experimental)
Group 2 will receive standard perioperative pain management for TKR; will undergo placebo femoral nerve block under ultrasound guidance with normal saline (NS) 20 cc. Following femoral bone cuts they will receive local anesthetic injection mixture of 30cc 0.25% bupivicaine with epinephrine 20 cc of preservative free normal saline, 30mg of toradol and 10 mg of morphine sulfate into the periarticular tissues including periosteum, joint capsule and posterior capsule of the knee joint and collateral ligaments and subcutaneous tissues. Prior to cementing prosthesis, a second injection with mixture of 20mL 1.3% Exparel and 40mL normal saline solution will be injected into the same tissues, joint capsules and collateral ligaments.
exparel Bupivacaine liposome injectable suspension
Prior to cementing of the prosthesis (minimum 20 minutes later), injection with mixture of 40 mL normal saline solution and 20mL 1.3% Exparel.
toradol Sprix
The patient will then undergo an ultrasound guided femoral nerve block in the preoperative area with bupivacaine 0.25% 20 cc. All patients will undergo unilateral TKR using a medial parapatellar approach. Intraoperatively prior to cementing of the TKR, patients will also receive a local anesthetic injection of a mixture of 30cc 0.25% bupivicaine with epinephrine, 30mg of toradol and 10 mg of morphine sulfate into the posterior capsule of the knee joint.
morphine sulfate Astramorph PF
The patient will then undergo an ultrasound guided femoral nerve block in the preoperative area with bupivacaine 0.25% 20 cc. All patients will undergo unilateral TKR using a medial parapatellar approach. Intraoperatively prior to cementing of the TKR, patients will also receive a local anesthetic injection of a mixture of 30cc 0.25% bupivicaine with epinephrine, 30mg of toradol and 10 mg of morphine sulfate into the posterior capsule of the knee joint.

Primary Outcomes

Measure
Pain Relief measured by VAS Questionnaire
time frame: One Year

Secondary Outcomes

Measure
Functional Ability measured by the KSS Questionnaire Score
time frame: One Year

Eligibility Criteria

Male or female participants from 18 years up to 73 years old.

Inclusion Criteria: • Patients between the ages of 18 - 73 who are undergoing primary, unilateral, Total Knee Replacement at the New England Baptist Hospital in Boston, Massachusetts are eligible to participate. Exclusion Criteria: - Patients with Revision or Complex Total Knee Replacements and are under the age of 18, or over the age of 73 will be excluded. - Patients with an ASA 4 level will be excluded. - Patients with a Body Mass Index of less than 20, and over 40, will be excluded. - Patients taking preoperative narcotics, patients with extreme sensitivity or allergy to narcotics or local anesthetics, and patients using opioid medications for at least 3 months leading up to surgery, will also be excluded.

Additional Information

Official title A Prospective Randomized Trial Comparing Femoral Nerve Black to Intraoperative Local Anesthetic Injection of Liposomal Bupivacaine (Exparel) in Total Knee Replacement
Principal investigator Carl Talmo, MD
Description A prospective, single blind study comparing femoral nerve blockade and intraarticular posterior capsular injection to interarticular injection of bupivicaine and liposomal bupivicaine (Exparel) alone.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by The New England Baptist Hospital.