Superficial Cervical Plexus Block With Either Clavipectoral Fascial Plane Block or Interscalene Brachial Block for Clavicle Surgeries Anesthesia

Ultrasound Guided Superficial Cervical Plexus Block With Either Clavipectoral Fascial Plane Block or Interscalene Brachial Block for Clavicle Surgeries Anesthesia: A Randomized Controlled Trial

This study aims to evaluate and compare the efficacy and safety of ultrasound guided superficial cervical plexus block (SCPB) with either clavipectoral fascial plane block (CPB) or interscalene brachial plexus block (ISBP) as an anesthetic technique for clavicle surgeries.

Study Overview

• Status: Recruiting
• Conditions: Ultrasound; Superficial Cervical Plexus Block; Clavipectoral Fascial Plane Block; Interscalene Brachial Block; Clavicle Surgeries
• Intervention / Treatment: Drug: Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB); Drug: Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP)

Detailed Description

Clavicular fracture is the most common injury in the shoulder, it occurs in 35% of shoulder girdle fractures. Clavicle surgeries often involve addressing fractures, dislocations, or corrective procedures, and they generally require precise and effective pain control.

Traditional superficial cervical plexus block (SCPB) combined with interscalene brachial plexus block (ISBP) can be used in the operation of clavicle fracture.

The SCPB targets the cervical plexus, providing sensory anesthesia to the skin overlying the cervical and upper thoracic regions. It is often used in conjunction with other blocks to enhance analgesia in the upper shoulder and clavicle area.

The ISBP block involves the administration of local anesthetic at the level of the brachial plexus, typically performed between the anterior and middle scalene muscles. This approach provides comprehensive analgesia for the shoulder, upper arm, and part of the clavicular area.

Clavipectoral fascial plane block (CPB) is a new regional nerve block and can be used in anesthesia and postoperative analgesia for clavicle fracture surgery. CPB provides analgesia to the clavicular region and the upper shoulder.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed M Aboeldahab, Master; Phone Number: 00201069784512; Email: ahmed.aboeldahab1422@gmail.com

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta university
      • Sub-Investigator: Mohammed S ElSharkawy, MD
      • Contact: Ahmed M Aboeldahab, Master; Phone Number: 00201069784512; Email: ahmed.aboeldahab1422@gmail.com
      • Sub-Investigator: Kamal E Haikal, MD
      • Sub-Investigator: Ahmed M Elsheikh, MD
      • Sub-Investigator: Mohamed S Abdelghany, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 to 65 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I, II.
• Patients with unilateral clavicular fractures undergo elective internal fixation of clavicle fractures.

Exclusion Criteria:

• Coagulopathy.
• Patients with infection at block site.
• Allergy to local anesthetics.
• Patient with morbid obesity (body mass index >35 kg/m2).
• Pre-existing neurological disease.
• Difficult communication.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Patients will receive Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB).	Drug: Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB); Patients will receive Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB).; Other Names: Group I
Experimental: Group II; Patients will receive Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP).	Drug: Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP); Patients will receive Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP); Other Names: Group II

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate	The block will be considered successful when complete sensory block is achieved within 45 min after injection of the study drug and inadequate block will be converted to general anesthesia and excluded from the study.	Intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of patient satisfaction	The degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).	24 hours postoperatively
First request of the rescue analgesia	First request of the rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated	24 hours postoperatively
Total morphine consumption	Rescue analgesia of morphine will be given as 2 mg bolus if the visual Analogue Scale (VAS)> 3 to be repeated after 30 min if pain persists until the VAS < 4. Each patient will be instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").	24 hours postoperatively
Incidence of Complications	Incidence of complications as local anesthetic systemic toxicity, nerve injury, diaphragmatic paresis, pneumothorax and high epidural block.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 8, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 36265MD331/12/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No