RECRUITING

Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients

Description

The purpose of this trial is to compare the difference in the proportion of patients with tolerable pain scores, VAS pain scores, quality of recovery and opioid use in milligram equivalents (at 24, 48, 72, 96 and 120 hours postoperatively) in patients undergoing shoulder arthroplasty who receive interscalene blocks with or without Liposomal Bupivacaine. This is a prospective randomized, double-blinded, controlled trial that will enroll 130 subjects undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty. Participants who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either 36 mL of 0.5% bupivacaine (PB group) or 10 mL of liposomal bupivacaine and 20 mL of 0.25 % bupivacaine and 6 mL of saline (LB group).

Study Overview

Study Details

Study overview

The purpose of this trial is to compare the difference in the proportion of patients with tolerable pain scores, VAS pain scores, quality of recovery and opioid use in milligram equivalents (at 24, 48, 72, 96 and 120 hours postoperatively) in patients undergoing shoulder arthroplasty who receive interscalene blocks with or without Liposomal Bupivacaine. This is a prospective randomized, double-blinded, controlled trial that will enroll 130 subjects undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty. Participants who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either 36 mL of 0.5% bupivacaine (PB group) or 10 mL of liposomal bupivacaine and 20 mL of 0.25 % bupivacaine and 6 mL of saline (LB group).

A Double-Blind Randomized Comparison Trial of Postoperative Pain in Patients Undergoing Total Shoulder Arthroplasty Who Receive Interscalene Blocks With or Without Liposomal Bupivacaine (PoPTSAWoW Trial)

Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients

Condition
Total Shoulder Arthroplasty
Intervention / Treatment

-

Contacts and Locations

Skokie

NorthShore University HealthSystem, Skokie, Illinois, United States, 60076

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Subject ages 18-90 years old
  • * Male or Female subjects
  • * Weight ≥ 60 kg.
  • * Must be able to consent in English
  • * Ages: \<18 and \>90
  • * Weight \< 60 kg
  • * Multiple surgeries during one hospital stay
  • * Emergency surgery
  • * Allergy or any contraindication to local anesthetics used in trial.
  • * Pregnancy
  • * Contraindicated for use of liposomal bupivacaine
  • * Severe liver/kidney disease
  • * Defined as a diagnosis of end-stage renal disease (ESRD) defined as being on dialysis
  • * Subject who received another local anesthetic block prior to the interscalene block.
  • * Unable to consent in English

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Johnny K. Lee,

Johnny K Lee, MD, PRINCIPAL_INVESTIGATOR, NorthShore University HealthSystem

Study Record Dates

2024-10-01