Clinical trial NCT06106399: US Guided WALLANT vs CPB Block for Clavicle Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Clavicle Fracture
Clavicle Injury
Keywords: wide awake local anesthesia
clavipectoral fascia plane block
clavicle surgery
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 Arms model
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: efficacy of the block as a sole anesthetic technique
timeFrame: 6 months
Secondary outcomes:
measure: 24 hour postoperative opioid consumption
timeFrame: 6 months
measure: patient satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Azhar University
state: Naser City
Study officials:
References:
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.
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.
citation: 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.