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NCT Number: NCT07146685

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

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.

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Key information

Conditions

Rebound Pain Interscalene Block Shoulder Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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.

    Patients will be Assessed 24 hours after intervention for a pain score between 0 and 10, 10 being the worst pain imaginable.

Secondary outcomes

  1. Qor15 score questionnaire.

    Time frame: 24, 48 and 72 hours.

    Patient will answer QoR15 questionnaire

  2. Lowest NRS pain score

    Time frame: 24, 48, 72 hours

    Patient will be assessed for lowest NRS pain scores

  3. Opioid Use

    Time frame: Assessed at 72 hours

    Total doses used will be converted to MMEs.

  4. Sensory Block Duration

    Time frame: Assessed at 24 hours.

    We will ask the patient how long they felt the nerve block was effective, in terms of hours.

  5. Presence of dyspnea/shortness of breath

    Time frame: Assessed at 24 hours.

    We will ask the patient if they ever had trouble breathing or shortness of breath during the duration of the block.

  6. Presence of Nausea or Vomiting

    Time frame: 24, 48, 72 hours

    We will ask the patient if there was any incidence of nausea or vomiting.

  7. Presence of persistent paresthesia

    Time frame: 24, 48, and 72 hours.

    We will ask the patient if there is any presence of persistent paresthesia.

Study contacts

Contact information is provided by the study sponsor or research team.

Brett Elmore, MD

CONTACT

[email protected]

434-924-3627

Leon N Grinman, DO

CONTACT

[email protected]

434-924-3627

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Acronym: RPRCT

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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