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

NCT05824832 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 216009
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative

Keywords

buprenorphine; clonidine; dexamethasone; brachial plexus blocks; pain; shoulder; surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (1)

• Pain reported via a numeric rating scale (NRS)

  48 hours

Study Arms (2)

Interscalene block with the addition of buprenorphine, clonidine, dexamethasone

EXPERIMENTAL

Interscalene brachial plexus blocks (ISB) is performed with a 22g x 50 mm PAJUNK SonoPlexⓇ II Facet S echogenic needle. Once adequate needle visualization is achieved within the correct anatomic position and plane, 30mL of 0.5% bupivacaine with 100 mcg clonidine, 0.3 mg buprenorphine, and 4 mg dexamethasone will be injected.

Drug: Interscalene block with the addition of buprenorphine, clonidine, dexamethasone

Interscalene block with buprenorphine alone

ACTIVE COMPARATOR

Interscalene brachial plexus blocks (ISB) is performed with a 22g x 50 mm PAJUNK SonoPlexⓇ II Facet S echogenic needle. Once adequate needle visualization is achieved within the correct anatomic position and plane 30mL of 0.5% bupivacaine will be injected.

Drug: Interscalene block with buprenorphine alone

Interventions

Interscalene block with the addition of buprenorphine, clonidine, dexamethasone DRUG

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

Also known as: Nerve block with buprenorphine, clonidine, dexamethasone

Interscalene block with the addition of buprenorphine, clonidine, dexamethasone

Interscalene block with buprenorphine alone DRUG

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

Also known as: Nerve block with buprenorphine alone

Interscalene block with buprenorphine alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years old
• Patients undergoing shoulder arthroscopy
• Patients willing to participate and sign informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Chicago

Maywood, Illinois, 60153, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Clonidine; Dexamethasone; Nerve Block; Buprenorphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons

Study Officials

• Audrice Francois, MD

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Fargo

CONTACT

708-216-8046; sfargo@luc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective randomized single-blinded clinical trial. 1:1 Randomization with 2 groups. Group 1: 50% of participants will receive an Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine during surgery. Group 2: 50% of participants will receive an Interscalene block alone during surgery.

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 24, 2023
• Study Start: February 28, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)