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

November 14, 2024 updated by: Sara Gamal Ibrahem Othman, Assiut University
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group CPB
Clavipectoral fascia plane block group
Drug: Bupivacaine with Dexamethasone Solution
10 to 15 ml %0.25 bupivacaine & 4 mg Dexamethazone
Experimental: Group ISBP & SCPB
Interscalene brachial plexus block & superficial cervical plexus block group
Drug: Bupivacaine with Dexamethasone Solution
10 to 15 ml %0.25 bupivacaine & 4 mg Dexamethazone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Estimated)

November 18, 2024

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISBP VS CPB Clavicle Surgeries

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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