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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05881473
Other study ID # fracture clavicle
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date September 20, 2023

Study information

Verified date October 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date September 20, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 hemodynamics Heart rate every 2 hours for 8 hours
Secondary hemodynamics mean arterial blood pressure every 2 hours for 8 hours
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Recruiting NCT05315284 - The Clinical and Radiological Outcomes of the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle N/A