Clavipectoral Fascial Plane Block Versus Superficial Cervical Block in Fracture Clavicle

NCT05881473 | Completed

• 1 other identifier: fracture clavicle
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Ultrasound-guided Clavipectoral fascial plane block versus ultrasound-guided superficial Cervical plexus block in patients undergoing fracture clavicle operation

Conditions

Fracture Clavicle

Keywords

fracture clavicle; clavipectoral block; superficial cervical block

Outcome Measures

Primary Outcomes (1)

• visual analogue score (VAS score) post operative

  change in visual analogue score (VAS score) to assess pain post operative described as 10= the sever pain and zero = no pain

  starting at the recovery room then every 2 hours for 8 hours post operatively

Secondary Outcomes (2)

• hemodynamics

  every 2 hours for 8 hours

• hemodynamics

  every 2 hours for 8 hours

Study Arms (2)

Group cervical: (control group):

OTHER

This group includes (40) patients. The patient will be placed in a supine position with the head turned to the contralateral side for adequate exposure of the neck and the upper chest. A linear high-frequency ultrasound probe (6-13 MHz, Sonosite) will be placed at the lateral side of the neck over the midpoint of the sterno-cleido-mastoid muscle at the level of the cricoid cartilage, which corresponds with the C6 transverse process. Once the muscle is identified, the probe will then be moved posteriorly until the posterior tapering edge of the muscle is identified where the interscalene groove between the anterior and middle scalene muscles is identified. Then, the superficial cervical plexus (SCP) will be visualized. A five-cm block needle will then be introduced from lateral to medial using the posterior-in-plane technique until its tip is placed near the SCP above the prevertebral fascia.10 mL of 0.5% Bupivacaine will be deposited.

Diagnostic Test: pain assessment after clavicular fracture repair

Group clavipectoral: (study group)

OTHER

This group includes (40) patients will have medial and lateral clavipectoral (CPB) block ultrasound guided using 20 ml Bupivacaine 0.5% for medial and lateral block equally after induction of general anesthesia. The patient will be placed in a supine position with the head turned to the contralateral side, and the shoulder will be padded with a small pillow. a 6- to 13-MHz linear array probe will be used for regional anesthesia. During CPB, an ultrasound probe will be placed on both the inner and outer one-third of the anterior surface of the clavicle. Using the in-plane technique, a 22-gauge needle will be inserted and advanced into the space between the periosteum of the clavicle and clavipectoral fascia in a caudal to cephalad direction, and a total of 20 mL of 0.5% Bupivacaine will be equally injected medially and laterally

Diagnostic Test: pain assessment after clavicular fracture repair

Interventions

pain assessment after clavicular fracture repair DIAGNOSTIC_TEST

This group includes (40) patients will have medial and lateral clavipectoral (CPB) block ultrasound guided using 20 ml Bupivacaine 0.5% for medial and lateral block equally after induction of general anesthesia.

Group cervical: (control group):; Group clavipectoral: (study group)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 21 to 60 years
• Both gender
• Isolated fracture clavicle.
• ASA classification 1 \& 2

You may not qualify if:

• Polytrauma patients with multiple fractures.
• Hemodynamically unstable patients.
• Patients with infection at the injection site.
• Refusal of patients.
• Patients with disturbed anatomical plane.
• Patients with a known history of allergy to local anesthetic will be used.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: May 31, 2023
• Study Start: June 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 20, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)