Clavipectoral Fascial Plane Block Versus Superficial Cervical Block in Fracture Clavicle

NCT ID: NCT05881473

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-09-20

Brief Summary

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

Detailed Description

The clavipectoral fascial plane block (CPB) is a novel regional anesthesia technique that has been utilized for clavicular fracture surgery. It has been hypothesized that the CPB is an effective regional anesthesia technique for peri-operative analgesia since the terminal branches of many of the sensory nerves like suprascapular, subclavian, lateral pectoral, and long thoracic nerves pass through the plane between the clavipectoral fascia and the clavicle itself.

The ultrasound-guided superficial cervical plexus (SCP) block may be useful for providers in emergency care settings who care for patients with ear, neck, and clavicular region injuries, including clavicle fractures and acromioclavicular dislocations. The SCP originates from the anterior rami of the C1-C4 spinal nerves and gives rise to 4 terminal branches (greater auricular, lesser occipital, transverse cervical, and suprascapular nerves) that provide sensory innervation to the skin and superficial structures of the anterolateral neck and sections of the ear and shoulder.

Conditions

Fracture Clavicle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group cervical: (control group):

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.

Group Type: OTHER

pain assessment after clavicular fracture repair

Intervention Type: 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 clavipectoral: (study group)

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

Group Type: OTHER

pain assessment after clavicular fracture repair

Intervention Type: 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.

Interventions

pain assessment after clavicular fracture repair

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age from 21 to 60 years

2. Both gender

3. Isolated fracture clavicle.

4. ASA classification 1 & 2

Exclusion Criteria

1. Polytrauma patients with multiple fractures.

2. Hemodynamically unstable patients.

3. Patients with infection at the injection site.

4. Refusal of patients.

5. Patients with disturbed anatomical plane.

6. Patients with a known history of allergy to local anesthetic will be used.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Amr Gaber

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

fracture clavicle

Identifier Type: -

Identifier Source: org_study_id