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NCT Number: NCT06692010

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

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine with Dexamethasone Solution

Drug

10 to 15 ml %0.25 bupivacaine & 4 mg Dexamethazone

Primary outcomes

  1. Pain Scores

    Time frame: 24 hours

    Postoperative pain level will be assessed using a visual analog scale (VAS) from (0 that's no pain to 10 that's unbearable pain) at specific time points (1, 6, 12, 24 hours post-surgery)

Study contacts

Contact information is provided by the study sponsor or research team.

Sara gamal ibrahem Othman, resident doctors

CONTACT

[email protected]

+201066121775

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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