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

NCT06692010 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: ISBP VS CPB Clavicle Surgeries
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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

Conditions

Clavicle Fracture

Keywords

Clavipectoral Fascia Block; Interscalene Brachial Plexus Block

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  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

Study Arms (2)

Group CPB

EXPERIMENTAL

Clavipectoral fascia plane block group

Drug: Bupivacaine with Dexamethasone Solution

Group ISBP & SCPB

EXPERIMENTAL

Interscalene brachial plexus block \& superficial cervical plexus block group

Drug: Bupivacaine with Dexamethasone Solution

Interventions

Bupivacaine with Dexamethasone Solution DRUG

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

Group CPB; Group ISBP & SCPB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Sara gamal ibrahem Othman, resident doctors

CONTACT

+201066121775; Sara.16266074@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at Anesthesia, Intensive Care and Pain Management department

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 18, 2024

Record last verified: 2024-11