Exparel Infiltration in Anterior Cruciate Ligament Reconstruction

Liposomal Bupivacaine Versus Femoral Nerve Block for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial

This is a randomized, single blinded, standard of care controlled clinical trial. All adult patients over sixteen desiring anterior cruciate ligament reconstruction will be eligible. The study compares pain control and opioid consumption in patients undergoing ACL reconstruction between patients receiving liposomal bupivacaine and those who underwent a preoperative femoral nerve block.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Procedure: Femoral nerve block; Drug: Liposomal bupivacaine; Drug: Ropivacaine

Detailed Description

Study Design: A randomized single blinded standard of care controlled clinical trial comparing pain management interventions. All patients over age sixteen and scheduled for primary or revision anterior cruciate ligament reconstruction (ACL) a single fellowship trained sports surgeons will be eligible for inclusion. Patients will be excluded if their medical history presents known allergies or intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug abuse, and pregnancy. Secondary exclusion criterion is an intact ACL.

Liposomal Bupivacaine has a refrigerated shelf life of one month in our facility. Patients will be sequentially recruited into the randomization process. Liposomal Bupivacaine will be held by the Henry Ford hospital pharmacy up to one month prior to planned anterior cruciate ligament reconstruction in anticipation of surgery on eligible patients. The sterile solutions will be delivered to and kept by the inpatient clinical pharmacy until the date of surgery and delivered to the operating room at the beginning of a surgical case. The current dose of Liposomal Bupivacaine has been chosen based on previously published data of local infiltrative analgesia with Liposomal Bupivacaine and one published study on Liposomal Bupivacaine efficacy.

The week prior to surgery, patients will be randomized to receive Local infiltration anesthesia (LIA) with Liposomal Bupivacaine, or Femoral nerve block (FNB) using a computer generated sequence. The results of randomization will be securely delivered to the anesthesiologist and the surgeon the week prior. The anesthesiologist will view the assigned group to determine if a preoperative FNB will be given. Depending on the randomization group either an Liposomal Bupivacaine solution will be delivered to the operating room for local infiltration or the anesthesiologist will perform a preoperative FNB.

Patients in the Liposomal Bupivacaine group will receive LIA with 10cc(133mg) of Liposomal Bupivacaine solution dissolved in 20cc of sterile saline after harvest of the hamstring graft or patella tendon graft. The solution will be applied to the wound bed, graft site, and periosteum. The solution will be left unperturbed for five minutes. Thereafter the solution will be suctioned from the wound and the knee joint. Incisions will be closed in typical fashion and the wound dressed.The tourniquet will be deflated.

Patient in the FNB will receive postoperative ultrasound guided FNB. Experienced anesthesiologists will apply all FNBs in this study.

Following the procedure pain will be accessed subjectively through visual analog scale and numeric rating scale pain scores, pain diaries given to the patient to record at home, pain summary scores at follow up visits and objectively through narcotic pain requirement. A blind observer will also access outcomes.

Planned Data Analysis:

Means and standard deviations, as well as medians and interquartile ranges will be computed for pain scores.These outcomes will be compared by Wilcoxon rank sum tests. The amount of pain medication and pain scores will be compared by Wilcoxon rank sum tests.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients over the age of 16 scheduled for primary or revision anterior cruciate ligament reconstruction by one fellowship trained sports surgeon will be eligible for inclusion

Exclusion Criteria:

• Patients will be excluded if their medical history presents known allergies or intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug abuse, and pregnancy. Secondary exclusion criterion is an intact ACL

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Femoral Nerve Block; Patients in this group received preoperative ultrasound guided femoral nerve blocks by senior anesthesiologist using ropivicaine.	Procedure: Femoral nerve block; Pre-operative femoral nerve block; Drug: Ropivacaine; Ropivicaine was used in all femoral nerve blocks
Experimental: Liposomal Bupivacaine; Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.	Drug: Liposomal bupivacaine; Local infiltration of liposomal bupivacaine; Other Names: Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain levels	Patients recorded pain lvls every four hours using VAS scales for four days post operatively	4 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine equivalents	Patients recorded opioid intake for four days postoperatively	4 days postoperatively

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: November 15, 2015
• First Posted (Estimated): November 17, 2015

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: patient satisfaction; liposomal bupivacaine; pain control; Anterior cruciate ligament reconstruction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine
• Other Study ID Numbers: EXP-ACL