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

NCT ID: NCT07146685

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2029-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Rebound Pain Shoulder Arthroplasty Interscalene Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized control study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Concentrated

Standard management of higher percent local anesthetic: 0.5% Bupivacaine

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type 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).

Dilute

More dilute local : 0.25% Bupivacaine

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Leon Grinman

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leon N Grinman, DO

Role: PRINCIPAL_INVESTIGATOR

UVA

Locations

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UVA Health

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Central Contacts

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Leon N Grinman, DO

Role: CONTACT

434-924-3627

Brett Elmore, MD

Role: CONTACT

434-924-3627

Facility Contacts

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Leon N Grinman, DO

Role: primary

434-924-3627

References

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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.

Reference Type BACKGROUND
PMID: 9773699 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22664978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37337808 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34535548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37833472 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33390261 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25822923 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30124544 (View on PubMed)

Other Identifiers

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302714

Identifier Type: -

Identifier Source: org_study_id

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