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

Sponsor

Loyola University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05824832

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Interscalene block with the addition of buprenorphine, clonidine, dexamethasone Drug: Interscalene block with buprenorphine alone	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 28, 2023

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interscalene block with the addition of buprenorphine, clonidine, dexamethasone 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 Addition of the adjuvant buprenorphine, dexamethasone, and clonidine in the nerve block performed prior to shoulder arthroscopy surgery Other Names: Nerve block with buprenorphine, clonidine, dexamethasone
Active Comparator: Interscalene block with buprenorphine alone 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 Addition of the adjuvant buprenorphine alone the in nerve block performed prior to shoulder arthroscopy surgery Other Names: Nerve block with buprenorphine alone

Arm

Intervention/Treatment

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

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

Addition of the adjuvant buprenorphine, dexamethasone, and clonidine in the nerve block performed prior to shoulder arthroscopy surgery

Other Names:

Nerve block with buprenorphine, clonidine, dexamethasone

Active Comparator: Interscalene block with buprenorphine alone

Drug: Interscalene block with buprenorphine alone

Addition of the adjuvant buprenorphine alone the in nerve block performed prior to shoulder arthroscopy surgery

Other Names:

Nerve block with buprenorphine alone

Outcome Measures

Primary Outcome Measures

Morphine requirement post surgery [24 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

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.