Recruiting

Local Anesthetic

Sponsor:

University of Virginia

Code:

NCT07146685

Conditions

Rebound Pain

Shoulder Arthroplasty

Interscalene Block

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine

Study Details

Brief summary:

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.

Conditions

Rebound Pain

Shoulder Arthroplasty

Interscalene Block

Study ID

NCT07146685

Start date

May 13, 2026

Status verified date

Sep, 2026

Completion date

Jan 28, 2029

Anticipated

Primary completion date

Jan 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Concentrated

Standard management of higher percent local anesthetic: 0.5% Bupivacaine

experimental: Dilute

More dilute local : 0.25% Bupivacaine

Interventions

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).

Primary outcome measure

  • Max NRS Pain Score at 24 hours [ Time Frame: 24 hours after intervention ]

Central Contacts and Locations

Central contacts

Leon N Grinman, DO

434-924-3627Lngrinman@gmail.com

Brett Elmore, MD

434-924-3627elmorbr@gmail.com

Locations

UVA Health

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Leon N Grinman, DO

434-924-3627Lngrinman@gmail.com

More Information

Sponsor

University of Virginia

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • local anesthetics
  • rebound pain
  • brachial plexus
  • shoulder arthroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-09-09.