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

NCT ID: NCT05824832

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2026-06-30

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.

Detailed Description

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interscalene block with the addition of buprenorphine, clonidine, dexamethasone

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.

Group Type: EXPERIMENTAL

Interscalene block with the addition of buprenorphine, clonidine, dexamethasone

Intervention Type: DRUG

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

Interscalene block with buprenorphine alone

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.

Group Type: ACTIVE_COMPARATOR

Interscalene block with buprenorphine alone

Intervention Type: DRUG

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

Interventions

Interscalene block with the addition of buprenorphine, clonidine, dexamethasone

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

Intervention Type: DRUG

Interscalene block with buprenorphine alone

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

Intervention Type: DRUG

Other Intervention Names

Nerve block with buprenorphine, clonidine, dexamethasone; Nerve block with buprenorphine alone

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Audrice Francois, MD, FASA

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Audrice Francois, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola University Chicago

Locations

Loyola University Chicago

Maywood, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Susan Fargo

Role: CONTACT

sfargo@luc.edu

708-216-8046

Facility Contacts

Susan Fargo

Role: primary

sfargo@luc.edu

708-216-8046

Other Identifiers

216009

Identifier Type: -

Identifier Source: org_study_id