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Clavipectoral Fascial Plane Block Versus Superficial Cervical Block in Fracture Clavicle

Primary Purpose

Fracture Clavicle

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pain assessment after clavicular fracture repair
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture Clavicle focused on measuring fracture clavicle, clavipectoral block, superficial cervical block

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group cervical: (control group):

Group clavipectoral: (study group)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

hemodynamics
Heart rate
hemodynamics
mean arterial blood pressure

Full Information

First Posted
March 31, 2023
Last Updated
October 5, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05881473
Brief Title
Clavipectoral Fascial Plane Block Versus Superficial Cervical Block in Fracture Clavicle
Official Title
Ultrasound-guided Clavipectoral Fascial Plane Block Versus Ultrasound-guided Superficial Cervical Plexus Block in Patients Undergoing Fracture Clavicle Operation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
September 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Clavicle
Keywords
fracture clavicle, clavipectoral block, superficial cervical block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group cervical: (control group):
Arm Type
Other
Arm Description
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.
Arm Title
Group clavipectoral: (study group)
Arm Type
Other
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
pain assessment after clavicular fracture repair
Intervention Description
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.
Primary Outcome Measure Information:
Title
visual analogue score (VAS score) post operative
Description
change in visual analogue score (VAS score) to assess pain post operative described as 10= the sever pain and zero = no pain
Time Frame
starting at the recovery room then every 2 hours for 8 hours post operatively
Secondary Outcome Measure Information:
Title
hemodynamics
Description
Heart rate
Time Frame
every 2 hours for 8 hours
Title
hemodynamics
Description
mean arterial blood pressure
Time Frame
every 2 hours for 8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Clavipectoral Fascial Plane Block Versus Superficial Cervical Block in Fracture Clavicle

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