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

Primary Purpose

Pain, Postoperative

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Interscalene block with the addition of buprenorphine, clonidine, dexamethasone
Interscalene block with buprenorphine alone
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring buprenorphine, clonidine, dexamethasone, brachial plexus blocks, pain, shoulder, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Loyola University ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interscalene block with the addition of buprenorphine, clonidine, dexamethasone

Interscalene block with buprenorphine alone

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 29, 2023
Last Updated
October 2, 2023
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT05824832
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
buprenorphine, clonidine, dexamethasone, brachial plexus blocks, pain, shoulder, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interscalene block with the addition of buprenorphine, clonidine, dexamethasone
Arm Type
Experimental
Arm 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.
Arm Title
Interscalene block with buprenorphine alone
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Interscalene block with the addition of buprenorphine, clonidine, dexamethasone
Other Intervention Name(s)
Nerve block with buprenorphine, clonidine, dexamethasone
Intervention Description
Addition of the adjuvant buprenorphine, dexamethasone, and clonidine in the nerve block performed prior to shoulder arthroscopy surgery
Intervention Type
Drug
Intervention Name(s)
Interscalene block with buprenorphine alone
Other Intervention Name(s)
Nerve block with buprenorphine alone
Intervention Description
Addition of the adjuvant buprenorphine alone the in nerve block performed prior to shoulder arthroscopy surgery
Primary Outcome Measure Information:
Title
Morphine requirement post surgery
Description
To compare the morphine equivalents administered in the first 24 hours after arrival in the recovery area between the two groups.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain reported via a numeric rating scale (NRS)
Description
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.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Fargo
Phone
708-216-8046
Email
sfargo@luc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrice Francois, MD
Organizational Affiliation
Loyola University Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Fargo
Phone
708-216-8046
Email
sfargo@luc.edu
First Name & Middle Initial & Last Name & Degree
Audrice Francois, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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