Treatment for Pain, Postoperative

Phase-Based Estimates
3
Effectiveness
3
Safety
Mayo Clinic in Rochester, Rochester, MN
Pain, Postoperative+1 More
Eligibility
18+
All Sexes
Eligible conditions
Pain, Postoperative

Study Summary

This study is evaluating whether a single injection of liposomal bupivacaine is as effective as a continuous interscalene nerve block for pain control after primary total shoulder arthroplasty.

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Eligible Conditions

  • Pain, Postoperative
  • Brachial Plexus Blocks

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes and 2 secondary outcomes in patients with Pain, Postoperative. Measurement will happen over the course of Post-Operative Day 1.

Post-Operative Day 1
Change in pain intensity scores
Opioid consumption
Day 7
Overall benefit of analgesic score (OBAS)
Quality of recovery score (QoR)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

continuous interscalene nerve blockade

This trial requires 88 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

continuous interscalene nerve blockade
Drug
Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.
liposomal bupivacaine single-shot interscalene blockade
Drug
Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to post-operative day 7
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to post-operative day 7 for reporting.

Who is running the study

Principal Investigator
J. K. P. D.
Jason K. Panchamia D.O., Principal Investigator
Mayo Clinic

Closest Location

Mayo Clinic in Rochester - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
Patients presenting for unilateral primary total shoulder arthroplasty (includes anatomic and reverse total shoulder arthroplasty).
Patients 18 years of age and older
Able to provide informed consent for him or herself

Patient Q&A Section

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Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Pain, Postoperative by sharing your contact details with the study coordinator.