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

Loyola University

Status and phase: Enrolling; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Interscalene block with buprenorphine alone; Drug: Interscalene block with the addition of buprenorphine, clonidine, dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT05824832

216009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Interscalene block with the addition of buprenorphine, clonidine, dexamethasone

Experimental group

Description:

Interscalene 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.

Treatment:

Drug: Interscalene block with the addition of buprenorphine, clonidine, dexamethasone

Interscalene block with buprenorphine alone

Active Comparator group

Description:

Interscalene 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.

Treatment:

Drug: Interscalene block with buprenorphine alone