Clinical trial NCT05824832: Buprenorphine, Clonidine, and Dexamethasone on Duration of Brachial Plexus Blocks for Upper Extremity Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: buprenorphine
clonidine
dexamethasone
brachial plexus blocks
pain
shoulder
surgery
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Morphine requirement post surgery
timeFrame: 24 hours
Secondary outcomes:
measure: Pain reported via a numeric rating scale (NRS)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
Study officials:
affiliation: Loyola University Chicago
name: Audrice Francois, MD
role: PRINCIPAL_INVESTIGATOR
References: