Clavipectoral Fascia Plane Block for Clavicle Surgery
- Conditions
- Clavicle InjuryClavicle Fracture
- Interventions
- Other: Clavipectoral fascia plane block group
- Registration Number
- NCT04328558
- Lead Sponsor
- Medipol University
- Brief Summary
The pain after clavicle fracture surgery may be managed with combined superficial cervical plexus-interscalene block and recently clavipectoral fascia plane block (CPB). CPB was defined by Valdes in 2017 firstly. It may be used for postoperative analgesia after clavicle surgery. CPB may be an alternative to interscalene brachial plexus block.
The aim of this study is to evaluate the efficacy of the US-guided CPB for postoperative analgesia management compare to no intervention control group after clavicle surgery. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).
- Detailed Description
Clavicle fracture is common in men and children after a direct fall on shoulder during sport activity such as cycling or an injury during a traffic accident. The pain after clavicle fracture surgery may be managed with combined superficial cervical plexus-interscalene block and recently clavipectoral fascia plane block (CPB). 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 The aim of this study is to evaluate the efficacy of the US-guided CPB for postoperative analgesia management compare to no intervention control group after clavicle surgery. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for clavicle surgery under general anesthesia
- history of bleeding diathesis,
- receiving anticoagulant treatment,
- known local anesthetics and opioid allergy,
- infection of the skin at the site of the needle puncture,
- pregnancy or lactation,
- patients who do not accept the procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group CPB = Clavipectoral fascia plane block group Clavipectoral fascia plane block group In group CPB, CPB will be performed with patients in the supine position. The probe will be placed on the anterior border of the medial third of the clavicle. A 22-gauge block needle will be inserted in a caudal to cephalic direction, the periosteum of the clavicle and the surrounding fascia will be visualized, 20 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.
- Primary Outcome Measures
Name Time Method Opioid consumption Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours The primary aim is to compare postoperative opioid consumption
- Secondary Outcome Measures
Name Time Method Pain scores (Visual analogue scores-VAS) Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours. Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores will be recorded
Trial Locations
- Locations (1)
Istanbul Medipol University Hospital
🇹🇷Istanbul, Bagcilar, Turkey