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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Interscalene block with the addition of buprenorphine, clonidine, dexamethasone
* Drug: Interscalene block with buprenorphine alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interscalene block with the addition of buprenorphine, clonidine, dexamethasone<br>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. | Drug: Interscalene block with the addition of buprenorphine, clonidine, dexamethasone<br>* Addition of the adjuvant buprenorphine, dexamethasone, and clonidine in the nerve block performed prior to shoulder arthroscopy surgery<br>* Other names: Nerve block with buprenorphine, clonidine, dexamethasone;|
| Active Comparator: Interscalene block with buprenorphine alone<br>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. | Drug: Interscalene block with buprenorphine alone<br>* Addition of the adjuvant buprenorphine alone the in nerve block performed prior to shoulder arthroscopy surgery<br>* Other names: Nerve block with buprenorphine alone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, buprenorphine, clonidine, dexamethasone, brachial plexus blocks, shoulder, surgery