US Guided WALLANT vs CPB Block for Clavicle Surgery

NCT06106399 | Unknown

• 1 other identifier: WALANT-CPB in clavicle surgery
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Clavicle Fracture; Clavicle Injury

Keywords

wide awake local anesthesia; clavipectoral fascia plane block; clavicle surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 24 hour postoperative opioid consumption

  6 months

• patient satisfaction

  6 months

Study Arms (2)

WALLANT (group 1)

ACTIVE COMPARATOR

wide awake local anesthesia and no tourniquet (WALLANT)

Procedure: WALLANT

CPB (group 2)

ACTIVE COMPARATOR

clavipectoral fascia plane block combined with superficial cervical plexus block (CPB)

Procedure: WALLANT

Interventions

WALLANT PROCEDURE

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

Also known as: CPB

CPB (group 2); WALLANT (group 1)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al Azhar University

Cairo, Naser City, 11811, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 35061634 BACKGROUND

• 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.

  PMID: 36011144 BACKGROUND

• 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.

  PMID: 35124948 BACKGROUND

Central Study Contacts

Ismail M Ahmed, Prof

CONTACT

00201117310053; ismailabdelgawad.623@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and the anesthiologist who perform postoperative pain will not know the group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOCTOR

Model Details: 2 Arms model

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: August 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)