US Guided WALLANT vs CPB Block for Clavicle Surgery

NCT ID: NCT06106399

Last Updated: 2023-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-03-01

Brief Summary

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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

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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.

Conditions

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Clavicle Fracture Clavicle Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 Arms model
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The patient and the anesthiologist who perform postoperative pain will not know the group.

Study Groups

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WALLANT (group 1)

wide awake local anesthesia and no tourniquet (WALLANT)

Group Type ACTIVE_COMPARATOR

WALLANT

Intervention Type PROCEDURE

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

CPB (group 2)

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

Group Type ACTIVE_COMPARATOR

WALLANT

Intervention Type PROCEDURE

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

Interventions

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WALLANT

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

Intervention Type PROCEDURE

Other Intervention Names

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CPB

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Ismail Mohamed Abdelgawad Ahmed

DOCTOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al Azhar University

Cairo, Naser City, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ismail M Ahmed, Prof

Role: CONTACT

00201117310053

Facility Contacts

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Ahmed M Selim, director

Role: primary

0020222611404

References

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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.

Reference Type BACKGROUND
PMID: 35061634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36011144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35124948 (View on PubMed)

Other Identifiers

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WALANT-CPB in clavicle surgery

Identifier Type: -

Identifier Source: org_study_id

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