Effect of Local Anesthetic Concentration on Rebound Pain: A Randomized Control Study (RPRCT)

August 20, 2025 updated by: Leon Grinman, University of Virginia
Randomized control study that compares different concentrations of local anesthetic to investigate whether a lower concentration of local anesthetic would contribute to lower rebound pain scores at 24 hours post op in patients undergoing anatomic or reverse total shoulder arthroplasty.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

168

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Total shoulder replacement patients (anatomic and reverse)
  • Adult patients (greater than or equal to 18 years)
  • Any gender
  • Any race

Exclusion Criteria:

  • - Chronic Pain diagnoses including:
  • substance/opioid use disorder
  • complex regional pain syndromes
  • fibromyalgia
  • Daily persistent opioid use spanning 3 months prior to surgery date
  • Allergy to local anesthetics or NSAIDS
  • Respiratory pathologies including:
  • CPAP- non-compliant / untreated obstructive sleep apnea
  • COPD
  • Restrictive lung disease (pulmonary fibrosis, interstitial pneumonia, etc)
  • Contralateral diaphragm dysfunction
  • BMI > 40
  • Ipsilateral extremity pre-existing nerve injury
  • GFR < 60
  • NSAID contraindications
  • Inability to follow up
  • Revision surgery
  • Patients requesting block as primary (avoidance of general anesthesia)
  • Need or request for brachial plexus catheter or liposomal bupivacaine
  • Vulnerable populations (pregnancy, incarceration, etc)
  • non-English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Concentrated
Standard management of higher percent local anesthetic: 0.5% Bupivacaine
Drug: Bupivacaine
We are comparing two concentrations of the same drug: 10 ml of 0.5% and 20 ml of 0.25%; We will use the same milligram dose (50 mg).
Experimental: Dilute
More dilute local : 0.25% Bupivacaine
Drug: Bupivacaine
We are comparing two concentrations of the same drug: 10 ml of 0.5% and 20 ml of 0.25%; We will use the same milligram dose (50 mg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Max NRS Pain Score at 24 hours
Time Frame: 24 hours after intervention; will also be assessed at 48 and 72 hours, though these are not the primary outcome for the study.
Patients will be Assessed 24 hours after intervention for a pain score between 0 and 10, 10 being the worst pain imaginable.
24 hours after intervention; will also be assessed at 48 and 72 hours, though these are not the primary outcome for the study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qor15 score questionnaire.
Time Frame: 24, 48 and 72 hours.
Patient will answer QoR15 questionnaire
24, 48 and 72 hours.
Lowest NRS pain score
Time Frame: 24, 48, 72 hours
Patient will be assessed for lowest NRS pain scores
24, 48, 72 hours
Opioid Use
Time Frame: Assessed at 72 hours
Total doses used will be converted to MMEs.
Assessed at 72 hours
Sensory Block Duration
Time Frame: Assessed at 24 hours.
We will ask the patient how long they felt the nerve block was effective, in terms of hours.
Assessed at 24 hours.
Presence of dyspnea/shortness of breath
Time Frame: Assessed at 24 hours.
We will ask the patient if they ever had trouble breathing or shortness of breath during the duration of the block.
Assessed at 24 hours.
Presence of Nausea or Vomiting
Time Frame: 24, 48, 72 hours
We will ask the patient if there was any incidence of nausea or vomiting.
24, 48, 72 hours
Presence of persistent paresthesia
Time Frame: 24, 48, and 72 hours.
We will ask the patient if there is any presence of persistent paresthesia.
24, 48, and 72 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Leon N Grinman, DO, UVA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

August 20, 2025

First Submitted That Met QC Criteria

August 20, 2025

First Posted (Estimated)

August 28, 2025

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 302714

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The details of the IPD Plan are unknown at this time, but it will likely be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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