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

University of Virginia

Status and phase: Not yet enrolling; Phase 4

Conditions: Interscalene Block; Shoulder Arthroplasty; Rebound Pain

Treatments: Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07146685

302714

Details and patient eligibility

About

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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 2 patient groups

Concentrated

Active Comparator group

Description:

Standard management of higher percent local anesthetic: 0.5% Bupivacaine

Treatment:

Drug: Bupivacaine

Dilute

Experimental group

Description:

More dilute local : 0.25% Bupivacaine

Treatment:

Drug: Bupivacaine