US Guided WALLANT vs CPB Block for Clavicle Surgery

Not Applicable

Recruiting

• Conditions: Clavicle Injury; Clavicle Fracture
• Interventions: Procedure: WALLANT

• Registration Number: NCT06106399
• Lead Sponsor: Al-Azhar University

Brief Summary

The clavicle is frequently fractured bone. regional anesthesia (RA) for clavicle surgery is always challenging due t complex innervation from the two plexuses (cervical and brachial). various RA techniques described for clavicle surgery include plexus blocks, fascial plane blocks,and truncal blocks.

Detailed Description

Clavipectoral Fascial Plane Block (CPB) is most commonly used as an anesthesia and postoperative analgesia technique to clavicle surgery.

This study is deigned to evaluate the feasibility of wide awake local anesthesia no tourniquet (WALANT) technique as a sole anesthesia in clavicle surgery, clavipectoral (CVP) fascia plane block + superficial cervical plexus plane block (CPB) as a sole anesthesia technique in clavicle surgery by using intraoperative verbal rating score (VRS) to determine how many patients need analgesia, sedation or convert to general anesthesia (GA), and postoperative assessment of patient satisfaction and 24 hour postoperative opioid consumption.

Study Timeline

• Study Start: 2023-08-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-24
• Study First Submitted QC: 2023-10-24
• Last Update Submitted: 2023-10-24
• Study First Posted: 2023-10-30
• Last Update Posted: 2023-10-30
• Primary Completion: 2024-02-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• American society of anesthesiologists (ASA) 1,2
• Unilateral clavicle fracture.

Exclusion Criteria

• psychologically unstable patient.
• uncooperative patient.
• patient refusal to be awake during surgery.
• allergy.
• infection at site of infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPB (group 2)	WALLANT	clavipectoral fascia plane block combined with superficial cervical plexus block (CPB)
WALLANT (group 1)	WALLANT	wide awake local anesthesia and no tourniquet (WALLANT)

Primary Outcome Measures

Name	Time	Method
efficacy of the block as a sole anesthetic technique	6 months	intra-operative verbal rating score to determine how many patients need supplementary analgesia,sedation or converted to general anesthesia

Secondary Outcome Measures

Name	Time	Method
24 hour postoperative opioid consumption	6 months	Post-operative hourly VAS for the first 6 hours, at 8 hours, at 12 hours, at 16 hours,then at 24 hours postoperative
patient satisfaction	6 months	patient satisfaction score immediately postoperative on hospital discharge and after 24 hours

Trial Locations

Locations (1)

Al Azhar University; 🇪🇬 Cairo, Naser City, Egypt