Clavicle Fracture, Clavicle Injury
Conditions
Keywords
Clavicle surgery, Postoperative pain management, Clavipectoral fascia plane block
Brief summary
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
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
Interventions
OTHERClavipectoral block
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.
Sponsors
Medipol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Outcomes Assessor and participant will be blinded to the study
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain scores (NRS) | Postoperative 24 hours period | The primary outcome is the NRS at postoperative 8th hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The use of rescue analgesia (number of participants and rate of tramodol using) | Postoperative 24 hours period | Tramodol using |
| Patient satisfaction | Postoperative at 24th hour | Patient satisfaction will be evaluated with seven item Likert scala |
Countries
Turkey (Türkiye)
Outcome results
None listed