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Not yet recruiting NCT06692010

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

Phase IV Interventional Clavicle Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bupivacaine with Dexamethasone Solution.
Who it may be relevant to
Registry conditions: Clavicle Fracture. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Drug Bupivacaine with Dexamethasone Solution
    10 to 15 ml %0.25 bupivacaine \& 4 mg Dexamethazone

Primary outcome measures

  • Pain Scores [Time frame: 24 hours]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 31612842
  • 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. PMID 32420714

Identifiers

NCT: NCT06692010 · ISBP VS CPB Clavicle Surgeries

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗