RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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)

Quick Facts

Study Start:2023-09-08
Study Completion:2024-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05900427

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.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject ages 18-90 years old
  2. * Male or Female subjects
  3. * Weight ≥ 60 kg.
  4. * Must be able to consent in English
  1. * Ages: \<18 and \>90
  2. * Weight \< 60 kg
  3. * Multiple surgeries during one hospital stay
  4. * Emergency surgery
  5. * Allergy or any contraindication to local anesthetics used in trial.
  6. * Pregnancy
  7. * Contraindicated for use of liposomal bupivacaine
  8. * Severe liver/kidney disease
  9. * Defined as a diagnosis of end-stage renal disease (ESRD) defined as being on dialysis
  10. * Subject who received another local anesthetic block prior to the interscalene block.
  11. * Unable to consent in English

Contacts and Locations

Study Contact

Johnny K Lee, MD
CONTACT
847-570-2760
JLee8@northshore.org

Principal Investigator

Johnny K Lee, MD
PRINCIPAL_INVESTIGATOR
NorthShore University HealthSystem

Study Locations (Sites)

NorthShore University HealthSystem
Skokie, Illinois, 60076
United States

Collaborators and Investigators

Sponsor: Johnny K. Lee

  • Johnny K Lee, MD, PRINCIPAL_INVESTIGATOR, NorthShore University HealthSystem

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-08
Study Completion Date2024-10-01

Study Record Updates

Study Start Date2023-09-08
Study Completion Date2024-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Total Shoulder Arthroplasty
  • Reverse Total Shoulder Arthroplasty