Effect of Clonidine Additive to suprascapular_ Costoclavicular Versus Standard Interscalene Block in Arthroscopic Shoulder Surgeries

NCT ID: NCT07256938

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-12-31

Brief Summary

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Postoperative analgesia for shoulder surgery is typically achieved by providing an interscalene brachial plexus block. However, a very common side effect of this block is hemi-diaphragmatic paralysis, a state which may not be tolerated in patients with pulmonary conditions such as COPD.

Recently, clinicians have explored new ways to provide satisfactory analgesia while minimizing the pulmonary side effects of the interscalene nerve block. One of these solutions might be to offer the patient a suprascapular nerve block combined to costoclavicular block. Since these blocks are performed lower in the neck or under the clavicle, the phrenic nerve is less likely to be blocked. Thus, fewer respiratory side effects have been reported when using such blocks.

Hypothesis The main hypothesis of this study is that the addition of clonidine to suprascapular block combined with costoclavicular block is not inferior to the standard interscalene brachial plexus block in terms of postoperative analgesia. We postulate that pain score postoperatively and opioid requirements will not differ significantly in patients who receive either block.

Our secondary objectives will consist in looking at the differences in intraoperative , arm motor block , diaphragmatic paresis , patient satisfaction and time for readiness to discharge from PACU .we hypothesize that these outcomes will be similar in both groups , with the exception of a potential reduction in arm motor block and diaphragmatic paresis in the combined suprascapular and costoclavicular block group The primary objective of this study will be to evaluate the postoperative pain score during arthroscopic shoulder surgery assessed by the pain score when comparing the effect of addition of clonidine to suprascapular\_costoclavicular versus standard interscalene

Detailed Description

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Conditions

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Arthroscopic Shoulder Surgeries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

US-guided costoclavicular block

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.5% (hyperbaric)

Intervention Type DRUG

5 mL bupivacaine 0.5%,

US-guided costoclavicular block

Intervention Type PROCEDURE

US-guided costoclavicular block

Interscalene brachial plexus block

Intervention Type PROCEDURE

single shot US-guided interscalene brachial plexus block

clonidine 1 mg / kg

Intervention Type DRUG

clonidine 1 mg / kg

Group B

US-guided interscalene brachial plexus block

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.5% (hyperbaric)

Intervention Type DRUG

5 mL bupivacaine 0.5%,

US-guided costoclavicular block

Intervention Type PROCEDURE

US-guided costoclavicular block

clonidine 1 mg / kg

Intervention Type DRUG

clonidine 1 mg / kg

single shot US-guided suprascapular nerve block

Intervention Type PROCEDURE

single shot US-guided suprascapular nerve block

Interventions

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Bupivacaine 0.5% (hyperbaric)

5 mL bupivacaine 0.5%,

Intervention Type DRUG

US-guided costoclavicular block

US-guided costoclavicular block

Intervention Type PROCEDURE

Interscalene brachial plexus block

single shot US-guided interscalene brachial plexus block

Intervention Type PROCEDURE

clonidine 1 mg / kg

clonidine 1 mg / kg

Intervention Type DRUG

single shot US-guided suprascapular nerve block

single shot US-guided suprascapular nerve block

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA status 1,2,3. Age( 18-60) years Elective shoulder arthroscopic surgery under general anesthesia and nerve bloc performed preoperatively

Exclusion Criteria

* Patient refusal Coagulation disorders. Anatomical disorders and/or neuropathic disease. BMI above 40. History of substance abuse. Chronic use of psychotropic and/or opioid. History of psychiatric diseases needing treatment. Contraindications to nerve block for shoulder surgery. Allergy to fentanil or any drug in the study protocol. Failure of nerve block performed in the preoperative block room when tested prior to entering the operating room (i.e. lack of loss of sensation to ice at the shoulder incision level).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Omar Fathy Khedr

residant doctor at Assiut university hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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clonidine + suprascapular

Identifier Type: -

Identifier Source: org_study_id

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