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

NCT07146685 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 302714
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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

Keywords

local anesthetics; rebound pain; brachial plexus; shoulder arthroscopy

Outcome Measures

Primary Outcomes (1)

• Max NRS Pain Score at 24 hours

  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 Outcomes (7)

• Qor15 score questionnaire.

  24, 48 and 72 hours.

• Lowest NRS pain score

  24, 48, 72 hours

• Opioid Use

  Assessed at 72 hours

• Sensory Block Duration

  Assessed at 24 hours.

• Presence of dyspnea/shortness of breath

  Assessed at 24 hours.

Study Arms (2)

Concentrated

ACTIVE COMPARATOR

Standard management of higher percent local anesthetic: 0.5% Bupivacaine

Drug: Bupivacaine

Dilute

EXPERIMENTAL

More dilute local : 0.25% Bupivacaine

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

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).

Concentrated; Dilute

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

UVA Health

Charlottesville, Virginia, 22903, United States

Location

Related Publications (8)

• Al-Kaisy A, McGuire G, Chan VW, Bruin G, Peng P, Miniaci A, Perlas A. Analgesic effect of interscalene block using low-dose bupivacaine for outpatient arthroscopic shoulder surgery. Reg Anesth Pain Med. 1998 Sep-Oct;23(5):469-73.

  PMID: 9773699 BACKGROUND

• Fredrickson MJ, Abeysekera A, White R. Randomized study of the effect of local anesthetic volume and concentration on the duration of peripheral nerve blockade. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):495-501. doi: 10.1097/AAP.0b013e3182580fd0.

  PMID: 22664978 BACKGROUND

• Lee HJ, Woo JH, Chae JS, Kim YJ, Shin SJ. Intravenous Versus Perineural Dexamethasone for Reducing Rebound Pain After Interscalene Brachial Plexus Block: A Randomized Controlled Trial. J Korean Med Sci. 2023 Jun 19;38(24):e183. doi: 10.3346/jkms.2023.38.e183.

  PMID: 37337808 BACKGROUND

• Woo JH, Lee HJ, Oh HW, Lee JW, Baik HJ, Kim YJ. Perineural dexamethasone reduces rebound pain after ropivacaine single injection interscalene block for arthroscopic shoulder surgery: a randomized controlled trial. Reg Anesth Pain Med. 2021 Nov;46(11):965-970. doi: 10.1136/rapm-2021-102795. Epub 2021 Sep 17.

  PMID: 34535548 BACKGROUND

• Uppal V, Barry G, Ke JXC, Kwofie MK, Trenholm A, Khan M, Shephard A, Retter S, Shanthanna H. Reducing rebound pain severity after arthroscopic shoulder surgery under general anesthesia and interscalene block: a two-centre randomized controlled trial of pre-emptive opioid treatment compared with placebo. Can J Anaesth. 2024 Jun;71(6):773-783. doi: 10.1007/s12630-023-02594-0. Epub 2023 Oct 13.

  PMID: 37833472 BACKGROUND

• Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31.

  PMID: 33390261 BACKGROUND

• Abdallah FW, Halpern SH, Aoyama K, Brull R. Will the Real Benefits of Single-Shot Interscalene Block Please Stand Up? A Systematic Review and Meta-Analysis. Anesth Analg. 2015 May;120(5):1114-1129. doi: 10.1213/ANE.0000000000000688.

  PMID: 25822923 BACKGROUND

• Lavand'homme P. Rebound pain after regional anesthesia in the ambulatory patient. Curr Opin Anaesthesiol. 2018 Dec;31(6):679-684. doi: 10.1097/ACO.0000000000000651.

  PMID: 30124544 BACKGROUND

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Leon N Grinman, DO

  UVA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leon N Grinman, DO

CONTACT

434-924-3627; Lngrinman@gmail.com

Brett Elmore, MD

CONTACT

434-924-3627; elmorbr@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: randomized control study

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 28, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

US (1)