Liposomal Bupivacaine in Total Shoulder Arthroplasty

Pain Clinical Trial

— EXP-TSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02570022
• Other study ID #: LB-TSA
• Status: Recruiting
• Phase: Phase 4
• First received: October 5, 2015
• Last updated: February 20, 2016
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: February 2016
• Source: Henry Ford Health System
• Contact: Kelechi r okoroha, m.d.
• Phone: 8324239895
• Email: kokoroh1[@]hfhs.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Liposomal bupivacaine
Local infiltration of liposomal bupivacaine

Procedure:
• Inter-scalene nerve block
Pre-operative inter-scalene nerve block

Drug:
• Ropivacaine
Ropivicaine was used for the inter-scalene nerve block.

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain levels	Patients recorded pain levels every four hours using VAS scales for four days post operatively	four days postoperatively	No
Secondary	morphine equivalents	Patients recorded opioid intake for four days postoperatively	four days postoperatively	No