US Guided WALLANT vs CPB Block for Clavicle Surgery

Study Overview
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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.

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

Conditions
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Clavicle Fracture, Clavicle Injury

Intervention / Treatment
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* Procedure: WALLANT


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 Arms model
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wide awake local anesthesia, clavipectoral fascia plane block, clavicle surgery