Exparel Infiltration in Anterior Cruciate Ligament Reconstruction

NCT ID: NCT02606448

Last Updated: 2023-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-11-30

Brief Summary

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.

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.

Conditions

Pain

Keywords

pain control; patient satisfaction; liposomal bupivacaine; Anterior cruciate ligament reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Femoral Nerve Block

Patients in this group received preoperative ultrasound guided femoral nerve blocks by senior anesthesiologist using ropivicaine.

Group Type: ACTIVE_COMPARATOR

Femoral nerve block

Intervention Type: PROCEDURE

Pre-operative femoral nerve block

Ropivacaine

Intervention Type: DRUG

Ropivicaine was used in all femoral nerve blocks

Liposomal Bupivacaine

Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.

Group Type: EXPERIMENTAL

Liposomal bupivacaine

Intervention Type: DRUG

Local infiltration of liposomal bupivacaine

Interventions

Liposomal bupivacaine

Local infiltration of liposomal bupivacaine

Intervention Type: DRUG

Femoral nerve block

Pre-operative femoral nerve block

Intervention Type: PROCEDURE

Ropivacaine

Ropivicaine was used in all femoral nerve blocks

Intervention Type: DRUG

Other Intervention Names

Exparel

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Charles S Day

Sub Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

EXP-ACL

Identifier Type: -

Identifier Source: org_study_id