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

Pain, Postoperative Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05824832
• Other study ID #: 216009
• Status: Recruiting
• Phase: Phase 4
• Start date: February 28, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2023
• Source: Loyola University
• Contact: Susan Fargo
• Phone: 708-216-8046
• Email: sfargo[@]luc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Loyola University Chicago	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	48 hours