Effect of Local Anesthetic Concentration on Rebound Pain: A Randomized Control Study
NCT ID: NCT07146685
Last Updated: 2025-08-28
Study Results
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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NOT_YET_RECRUITING
PHASE4
168 participants
INTERVENTIONAL
2026-01-01
2029-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Concentrated
Standard management of higher percent local anesthetic: 0.5% Bupivacaine
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).
Dilute
More dilute local : 0.25% Bupivacaine
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).
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).
Eligibility Criteria
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Inclusion Criteria
* Adult patients (greater than or equal to 18 years)
* Any gender
* Any race
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Virginia
OTHER
Responsible Party
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Leon Grinman
Assistant Professor
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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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302714
Identifier Type: -
Identifier Source: org_study_id
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