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

Not Applicable

Not yet recruiting

• Conditions: Rebound Pain; Shoulder Arthroplasty; Interscalene Block
• Interventions: Drug: Bupivacaine

• Registration Number: NCT07146685
• Lead Sponsor: University of Virginia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-20
• Study First Submitted QC: 2025-08-20
• Last Update Submitted: 2025-08-20
• Study First Posted: 2025-08-28
• Last Update Posted: 2025-08-28
• Study Start: 2026-01-01
• Primary Completion: 2028-01-01
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concentrated	Bupivacaine	Standard management of higher percent local anesthetic: 0.5% Bupivacaine
Dilute	Bupivacaine	More dilute local : 0.25% Bupivacaine

Primary Outcome Measures

Name	Time	Method
Max NRS Pain Score at 24 hours	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 Outcome Measures

Name	Time	Method
Qor15 score questionnaire.	24, 48 and 72 hours.	Patient will answer QoR15 questionnaire
Lowest NRS pain score	24, 48, 72 hours	Patient will be assessed for lowest NRS pain scores
Opioid Use	Assessed at 72 hours	Total doses used will be converted to MMEs.
Sensory Block Duration	Assessed at 24 hours.	We will ask the patient how long they felt the nerve block was effective, in terms of hours.
Presence of dyspnea/shortness of breath	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.
Presence of Nausea or Vomiting	24, 48, 72 hours	We will ask the patient if there was any incidence of nausea or vomiting.
Presence of persistent paresthesia	24, 48, and 72 hours.	We will ask the patient if there is any presence of persistent paresthesia.

Trial Locations

Locations (1)

UVA Health; 🇺🇸 Charlottesville, Virginia, United States