US Guided WALLANT vs CPB Block for Clavicle Surgery

Clavicle Fracture Clinical Trial

— WALANT-CPB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106399
• Other study ID #: WALANT-CPB in clavicle surgery
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: October 2023
• Source: Al-Azhar University
• Contact: Ismail M Ahmed, Prof
• Phone: 00201117310053
• Email: ismailabdelgawad.623[@]azhar.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: March 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clavicle Fracture
• Clavicle Injury

Intervention

Procedure:
• WALLANT
Comparison between (WALLANT) and (CPB) as a sole anesthesia in clavicle surgery

Locations

Country	Name	City	State
Egypt	Al Azhar University	Cairo	Naser City

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	patient satisfaction	patient satisfaction score immediately postoperative on hospital discharge and after 24 hours	6 months