Recruiting

Buprenorphine, Clonidine, Dexamethasone

Sponsor:

Loyola University

Code:

NCT05824832

Conditions

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Interscalene block with the addition of buprenorphine, clonidine, dexamethasone

Interscalene block with buprenorphine alone

Study Details

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

Study ID

NCT05824832

Start date

Feb 28, 2023

Status verified date

Mar, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

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

Interscalene block with buprenorphine alone

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

Primary outcome measure

  • Morphine requirement post surgery [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Susan Fargo

708-216-8046sfargo@luc.edu

Locations

Loyola University Chicago

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Susan Fargo

708-216-8046sfargo@luc.edu

Principal Investigator:

Audrice Francois, MD

More Information

Sponsor

Loyola University

Last update posted

Mar 7, 2025

Last verified

Mar, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2025-03-07.