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

Registration Number
NCT05824832
Lead Sponsor
Loyola University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
120
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Interscalene block with the addition of buprenorphine, clonidine, dexamethasoneInterscalene block with the addition of buprenorphine, clonidine, dexamethasoneInterscalene 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.
Interscalene block with buprenorphine aloneInterscalene block with buprenorphine aloneInterscalene 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.
Primary Outcome Measures
NameTimeMethod
Morphine requirement post surgery24 hours

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

Secondary Outcome Measures
NameTimeMethod
Pain reported via a numeric rating scale (NRS)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.

Trial Locations

Locations (1)

Loyola University Chicago

🇺🇸

Maywood, Illinois, United States

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