Liposomal Bupivacaine in Total Shoulder Arthroplasty (EXP-TSA)

Liposomal Bupivacaine Versus Interscalene Nerve Block for Pain Control After Shoulder Arthroplasty: A Prospective Randomized Trial

This is a randomized, single blinded, standard of care controlled clinical trial. All adult patients over eighteen desiring shoulder arthroplasty will be eligible. The study compares pain control and opioid consumption in patients undergoing shoulder arthroplasty between patients receiving liposomal bupivacaine and those who underwent a preoperative inter-scalene nerve block.

Study Overview

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

Detailed Description

Study Design: A randomized single blinded standard of care controlled clinical trial comparing pain management interventions. All patients over age eighteen and scheduled for primary shoulder arthroplasty (SA) a three fellowship trained 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.

Liposomal Bupivacaine has a refrigerated shelf life of one month the investigational 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 shoulder arthroplasty 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 Inter-scalene nerve block (INB) 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 INB 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 INB.

Patients in the Liposomal Bupivacaine group will receive LIA with 10cc(133mg) of Liposomal Bupivacaine solution dissolved in 20cc of sterile saline before wound closure. The solution will be applied to the wound bed, muscles, and periosteum. The solution will be left unperturbed for five minutes. Thereafter the solution will be suctioned from the wound and the shoulder joint. Incisions will be closed in typical fashion and the wound dressed.The tourniquet will be deflated.

Patients in the INB will receive postoperative ultrasound guided INB. Experienced anesthesiologists will apply all INBs 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): 57
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients over the age of 18 scheduled for primary shoulder arthroplasty by three fellowship trained surgeons 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.

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
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
Active Comparator: Inter-scalene nerve block; Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.	Procedure: Inter-scalene nerve block; Pre-operative inter-scalene nerve block; Other Names: Naropin; Drug: Ropivacaine; Ropivicaine was used for the inter-scalene nerve block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Levels	Patients recorded pain levels every four hours using Visual analog scales for four days post operatively. Average daily pain was calculated for each patient. Range of the visual analog scale was 0-10, where 0 indicated a lower amount of pain and 10 indicated higher amount of pain.	four days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine Equivalents	Patients recorded opioid intake for four days postoperatively. Patients average daily morphine consumption was determined by averaging total patients daily morphine consumption by the number of patients.	four days postoperatively

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: October 6, 2015
• First Posted (Estimate): October 7, 2015

Study Record Updates

• Last Update Posted (Estimate): October 13, 2016
• Last Update Submitted That Met QC Criteria: August 17, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: exparel; liposomal bupivacaine; Pain control; shoulder arthroplasty
• 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: LB-TSA