The Effectiveness of Clavipectoral Fascia Plane Block for Clavicle Surgery

Study Overview
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Brief Summary
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Clavipectoral fascia plane block (CPB). CPB was defined by Valdes in 2017 firstly. It may be used for postoperative analgesia after clavicle surgery. In the literature, data about CPB is so limited, however it seems a good option for pain management after clavicle fracture. The aim of this study is to evaluate the efficacy of the ultrasound-guided CPB for postoperative analgesia management and patient satisfaction in patients underwent clavicle surgery.

Detailed Description
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Clavipectoral fascia plane block (CPB) was defined by Valdes in 2017 firstly. It may be used for postoperative analgesia after clavicle surgery. The clavipectoral fascia covers the clavicular site of the pectoralis major muscle. It provides the potential interfascial space between the clavicle and the pectoralis major muscle. CPB provide effective analgesia after clavicle surgery. It is also easy to perform. With this advantage and its analgesic effectiveness for clavicle surgery, CPB may be an alternative to interscalene brachial plexus block. However, randomized clinical efficacy trials are needed to investigate the effectiveness of CPB for clavicle fractures. In the literature, data about CPB is so limited, however it seems a good alternative to brachial plexus block for pain management after clavicle fracture

Official Title
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The Effect of Clavipectoral Fascia Plane Block on Pain Management and Patient Satisfaction Following Clavicle Surgery: Randomized, Prospective Study

Conditions
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Clavicle Injury, Clavicle Fracture

Intervention / Treatment
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* Other: Clavipectoral block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) classification I-II Scheduled for clavicle surgery under general anesthesia Exclusion Criteria: bleeding diathesis, anticoagulation, thorax wall abnormalities study drug allergy, infection at the block area, pregnancy or lactation, patients who do not accept the procedure

Ages Eligible for Study
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Minimum Age: 18 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: 38 patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for clavicle surgery will be included in the study. Patients will be randomly divided into two groups (Group Clavipectoral and Group Control) including 19 patients each, before entering the operating room.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Clavipectoral = Clavipectoral block group<br>Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. Tramodol will be performed for rescue analgesia. | Other: Clavipectoral block<br>* Clavipectoral block will be performed with patients in the supine position. The probe will be placed on the anterior border of the medial third (or on the proximal or distal end, according to the localization of the fracture) of the clavicle. A 22-gauge, 50 mm block needle will be inserted in a caudal to cephalic direction, the periosteum of the clavicle and the surrounding fascia will be visualized, 30 ml of 0.25% bupivacaine will be injected between these two layers. The local anesthetic spread to medial and lateral third of the clavicle will be seen.<br>|
| No Intervention: Group Control = Control group<br>Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. Tramodol will be performed for rescue analgesia. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores (NRS) | The primary outcome is the NRS at postoperative 8th hour | Postoperative 24 hours period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The use of rescue analgesia (number of participants and rate of tramodol using) | Tramodol using | Postoperative 24 hours period | 
| Patient satisfaction | Patient satisfaction will be evaluated with seven item Likert scala | Postoperative at 24th hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clavicle surgery, Postoperative pain management, Clavipectoral fascia plane block