Clavipectoral Fascial Plane Block Versus Superficial Cervical Block in Fracture Clavicle

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05881473

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

39.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fracture Clavicle	Diagnostic Test: pain assessment after clavicular fracture repair	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Ultrasound-guided Clavipectoral Fascial Plane Block Versus Ultrasound-guided Superficial Cervical Plexus Block in Patients Undergoing Fracture Clavicle Operation

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Diagnostic Test: 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.
Other: 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	Diagnostic Test: 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.

Arm

Intervention/Treatment

Other: 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.

Diagnostic Test: pain assessment after clavicular fracture repair

Other: 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

Diagnostic Test: pain assessment after clavicular fracture repair

Outcome Measures

Primary Outcome Measures

visual analogue score (VAS score) post operative [starting at the recovery room then every 2 hours for 8 hours post operatively]
change in visual analogue score (VAS score) to assess pain post operative described as 10= the sever pain and zero = no pain

Secondary Outcome Measures

hemodynamics [every 2 hours for 8 hours]
Heart rate
hemodynamics [every 2 hours for 8 hours]
mean arterial blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amr Gaber, lecturer, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05881473

Other Study ID Numbers:

fracture clavicle

First Posted:

May 31, 2023

Last Update Posted:

May 31, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Amr Gaber, lecturer, Ain Shams University

fracture clavicle

clavipectoral block

superficial cervical block

Additional relevant MeSH terms:

Fractures, Bone

Study Results

No Results Posted as of May 31, 2023