Comparison Between Clavipectoral Fascia Block & Interscalene Brachial Plexus Block As Regard Adequacy of Anesthesia in Clavicle Surgeries

NCT ID: NCT06692010

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-01-01

Brief Summary

A newer technique called clavipectoral fascial plane block (CPB), introduced by Valdés-Vilches in 2017, involves injecting local anesthetic under ultrasound guidance between the clavipectoral fascia and periosteum at the injury site. This method offers a promising alternative for effective regional anesthesia in clavicular fracture surgeries. this study is aim to Comparison Between Use of Ultrasound guided Clavipectroal fascia block ( CPB ) & interscalene brachial plexus block ( ISBP ) As Regard Adeqacy of Anesthesia in clavicle Fracture

Detailed Description

Clavicle fractures represent 2.6% of all fractures and are commonly seen in emergency and surgical settings, particularly among young men due to sports or traffic incidents, predominantly affecting the mid-clavicle. Surgical intervention often yields better functional outcomes compared to conservative treatment. While general anesthesia is an option, it carries risks such as nausea, vomiting, and increased costs for patients. In contrast, regional anesthesia can effectively manage pain while minimizing complications associated with general anesthesia.

The supraclavicular nerve innervates the skin above the clavicle, but the sensory innervation of the clavicle itself remains debated. A combination of superficial cervical plexus block (SCPB) and interscalene brachial plexus block (ISBP) is frequently employed during clavicle fracture surgeries. The brachial plexus includes nerves from C5-8 and T1, while the cervical plexus comprises branches from both deep and superficial cervical structures. Although this combination can effectively address pain management during surgery, ISBP may lead to complications like diaphragmatic paralysis due to phrenic nerve involvement.

Conditions

Clavicle Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group CPB

Clavipectoral fascia plane block group

Group Type: EXPERIMENTAL

Bupivacaine with Dexamethasone Solution

Intervention Type: DRUG

10 to 15 ml %0.25 bupivacaine \& 4 mg Dexamethazone

Group ISBP & SCPB

Interscalene brachial plexus block \& superficial cervical plexus block group

Group Type: EXPERIMENTAL

Bupivacaine with Dexamethasone Solution

Intervention Type: DRUG

10 to 15 ml %0.25 bupivacaine \& 4 mg Dexamethazone

Interventions

Bupivacaine with Dexamethasone Solution

10 to 15 ml %0.25 bupivacaine \& 4 mg Dexamethazone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• . Patients who have isolated clavicle surgery. American Society of Anesthesiologists (ASA) classification I-II

Exclusion Criteria

• 1.Patient with Major Trauma Insult " Brain \ chest \ Abdomen " 2.History of bleeding diathesis 3.Patients receiving anticoagulant treatment, 4.Patients known local anesthetics and opioid allergy, 5.Infection of the skin at the site of the needle puncture, 6.Pregnant or lactating females, 7.Patients who do not accept the procedure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Sara Gamal Ibrahem Othman

Resident doctor at Anesthesia, Intensive Care and Pain Management department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sara gamal ibrahem Othman, resident doctors

Role: CONTACT

Sara.16266074@med.aun.edu.eg

+201066121775

References

Fugelli CG, Westlye ET, Ersdal H, Strand K, Bjorshol C. Combined Interscalene Brachial Plexus and Superficial Cervical Plexus Nerve Block for Midshaft Clavicle Surgery: A Case Series. AANA J. 2019 Oct;87(5):374-378.

Reference Type: BACKGROUND

PMID: 31612842 (View on PubMed)

Atalay YO, Ciftci B, Ekinci M, Yesiltas S. The effectiveness of clavipectoral fascia plane block for analgesia after clavicle surgery: a report of five cases. Minerva Anestesiol. 2020 Sep;86(9):992-993. doi: 10.23736/S0375-9393.20.14503-6. Epub 2020 May 18. No abstract available.

Reference Type: BACKGROUND

PMID: 32420714 (View on PubMed)

Other Identifiers

ISBP VS CPB Clavicle Surgeries

Identifier Type: -

Identifier Source: org_study_id