Buprenorphine, Clonidine, and Dexamethasone on Duration of Brachial Plexus Blocks for Upper Extremity Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interscalene block with the addition of buprenorphine, clonidine, dexamethasone, Interscalene block with buprenorphine alone.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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 - Drug Interscalene block with buprenorphine alone
Addition of the adjuvant buprenorphine alone the in nerve block performed prior to shoulder arthroscopy surgery
Primary outcome measures
- Morphine requirement post surgery [Time frame: 24 hours]
Secondary outcome measures (1)
- Pain reported via a numeric rating scale (NRS) [Time frame: 48 hours]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Loyola University Chicago — Maywood
Identifiers
NCT: NCT05824832 · 216009