Buprenorphine, Clonidine, and Dexamethasone on Duration of Brachial Plexus Blocks for Upper Extremity Surgery

Phase 4RecruitingNCT05824832

Loyola University120 enrolled

Overview

The goal of this clinical trial is to learn if there is a difference in morphine requirements in patients after upper extremity surgeries including shoulder arthroscopy. The main question it aims to answer is whether there is a difference between Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.

This study will be a prospective randomized single-blinded clinical trial. Patients undergoing shoulder arthroscopy who meet the inclusion criteria will be invited to participate in this study. A total of 120 patients will be recruited to participate. Patients will be randomized via a 1:1 ratio to either the Interscalene block with the addition of buprenorphine, clonidine, dexamethasone group or Interscalene block alone group The null hypothesis of this research study is that there will be no significant difference in morphine requirements between the Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Pain, Postoperative

Interventions

Interscalene block with the addition of buprenorphine, clonidine, dexamethasoneDRUG

Addition of the adjuvant buprenorphine, dexamethasone, and clonidine in the nerve block performed prior to shoulder arthroscopy surgery

Interscalene block with buprenorphine aloneDRUG

Addition of the adjuvant buprenorphine alone the in nerve block performed prior to shoulder arthroscopy surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients ≥ 18 years old * Patients undergoing shoulder arthroscopy * Patients willing to participate and sign informed consent Exclusion Criteria: * Severe COPD/other contraindication to general anesthesia * Patient with a weight of less than 60 kg * Dementia, not alert or oriented to person, place, or time * Chronic pain patient with daily opioid use at home. * Patient with allergy to local anesthetics * Patient refusal * Total shoulder arthroplasty * Concomitant pain in different area from operative site. * Pregnancy * Patient with active infection on the injection sites for the blocks * Patients unable or willing to understand or comply with the study protocol

Locations (1)

Loyola University Chicago

Maywood, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

Morphine requirement post surgery

To compare the morphine equivalents administered in the first 24 hours after arrival in the recovery area between the two groups.

Time frame: 24 hours

Secondary Outcomes

Pain reported via a numeric rating scale (NRS)

To measure pain via a numeric rating scale (NRS) immediately after arrival to recovery area from surgery (time: 0hr), and again at 2, 24, and 48 hours.

Time frame: 48 hours

Central Contacts

Susan Fargo

CONTACT

708-216-8046 sfargo@luc.edu

Data from ClinicalTrials.gov

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