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Not yet recruiting NCT07146685

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

Phase IV Interventional Rebound Pain Shoulder Arthroplasty Interscalene Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bupivacaine.
Who it may be relevant to
Registry conditions: Rebound Pain, Shoulder Arthroplasty, Interscalene Block. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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).

Primary outcome measures

  • 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.]
Secondary outcome measures (7)
  • Qor15 score questionnaire. [Time frame: 24, 48 and 72 hours.]
  • Lowest NRS pain score [Time frame: 24, 48, 72 hours]
  • Opioid Use [Time frame: Assessed at 72 hours]
  • Sensory Block Duration [Time frame: Assessed at 24 hours.]
  • Presence of dyspnea/shortness of breath [Time frame: Assessed at 24 hours.]
  • Presence of Nausea or Vomiting [Time frame: 24, 48, 72 hours]
  • Presence of persistent paresthesia [Time frame: 24, 48, and 72 hours.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • UVA Health — Charlottesville

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07146685 · 302714

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗