Effect of Local Anesthetic Concentration on Rebound Pain

Phase 4RecruitingNCT07146685

University of Virginia10 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rebound Pain Shoulder Arthroplasty Interscalene Block

Interventions

BupivacaineDRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UVA Health

Charlottesville, Virginia, United States

RECRUITING

Outcomes

Primary Outcomes

Max NRS Pain Score at 24 hours

Pain intensity measured using the Numeric Rating Scale (NRS), a 0-10 scale where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.

Time frame: 24 hours after intervention

Secondary Outcomes

Qor15 score questionnaire.

Patient will answer QoR15 questionnaire

Time frame: 24, 48 and 72 hours.

Lowest NRS pain score

Lowest pain intensity measured using the Numeric Rating Scale (NRS), a 0-10 scale where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.

Time frame: 24, 48, 72 hours

Opioid Use

Total doses used will be converted to Morphine Milligram Equivalents

Time frame: Assessed at 72 hours

Sensory Block Duration

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

Time frame: Assessed at 24 hours.

Presence of dyspnea/shortness of breath

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

Time frame: Assessed at 24 hours.

Presence of Nausea or Vomiting

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

Time frame: 24, 48, 72 hours

Central Contacts

Leon N Grinman, DO

CONTACT

434-924-3627 Lngrinman@gmail.com

Brett Elmore, MD

CONTACT

434-924-3627 elmorbr@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.