US Guided WALLANT vs CPB Block for Clavicle Surgery (WALANT-CPB)

Ultrasound Guided Wide Awake Local Anesthesia Versus Clavipectoral Fascia Plane Block With Superficial Cervical Plexus Block for Clavicle Surgery, Prospective Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Clavicle Fracture; Clavicle Injury
• Intervention / Treatment: Procedure: WALLANT

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 Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ismail M Ahmed, prof; Phone Number: 00201117310053; Email: ismailabdelgawad.623@azhar.edu.eg

Study Locations

• Egypt
  • Naser City
    • Cairo, Naser City, Egypt, 11811
      • Recruiting
      • Al Azhar University
      • Contact: ahmed m selim, director; Phone Number: 0020222611404; Email: info@azhar.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: WALLANT (group 1); wide awake local anesthesia and no tourniquet (WALLANT)	Procedure: WALLANT; Comparison between (WALLANT) and (CPB) as a sole anesthesia in clavicle surgery; Other Names: CPB
Active Comparator: CPB (group 2); clavipectoral fascia plane block combined with superficial cervical plexus block (CPB)	Procedure: WALLANT; Comparison between (WALLANT) and (CPB) as a sole anesthesia in clavicle surgery; Other Names: CPB

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Al-Azhar University

Publications and helpful links

General Publications

• Zhuo Q, Zheng Y, Hu Z, Xiong J, Wu Y, Zheng Y, Wang L. Ultrasound-Guided Clavipectoral Fascial Plane Block With Intermediate Cervical Plexus Block for Midshaft Clavicular Surgery: A Prospective Randomized Controlled Trial. Anesth Analg. 2022 Sep 1;135(3):633-640. doi: 10.1213/ANE.0000000000005911. Epub 2022 Jan 21.
• Lee CCM, Beh ZY, Lua CB, Peng K, Fathil SM, Hou JD, Lin JA. Regional Anesthetic and Analgesic Techniques for Clavicle Fractures and Clavicle Surgeries: Part 1-A Scoping Review. Healthcare (Basel). 2022 Aug 7;10(8):1487. doi: 10.3390/healthcare10081487.
• Azizi K, Benhamza S, Motiaa Y. Novel use of ultrasound guidance in wide-awake local anesthesia technique for clavicle surgery. Korean J Anesthesiol. 2022 Feb;75(1):103-105. doi: 10.4097/kja.21282. Epub 2021 Jun 30. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: wide awake local anesthesia; clavipectoral fascia plane block; clavicle surgery
• Other Study ID Numbers: WALANT-CPB in clavicle surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD are planned to be coded for privacy protection

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No