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NCT Number: NCT05824832

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Loyola University Chicago

Maywood, Illinois, 60153, United States

Location status: Recruiting

Location contact

Audrice Francois, MD

PRINCIPAL_INVESTIGATOR

Susan Fargo

CONTACT

[email protected]

708-216-8046

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Nerve block with 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

Other names: Nerve block with buprenorphine alone

Primary outcomes

  1. Morphine requirement post surgery

    Time frame: 24 hours

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

Secondary outcomes

  1. Pain reported via a numeric rating scale (NRS)

    Time frame: 48 hours

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Susan Fargo

CONTACT

[email protected]

708-216-8046

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Official study title

Effects of a Triple Adjuvant Combination of Buprenorphine, Clonidine, and Dexamethasone on Duration of Brachial Plexus Blocks for Upper Extremity Surgery, a Prospective, Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2023
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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