Clinical trial NCT05268874: The Effectiveness of Clavipectoral Fascia Plane Block for Clavicle Surgery
Official title: The Effect of Clavipectoral Fascia Plane Block on Pain Management and Patient Satisfaction Following Clavicle Surgery: Randomized, Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clavicle Fracture
Clavicle Injury
Keywords: Clavicle surgery
Postoperative pain management
Clavipectoral fascia plane block
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain scores (NRS)
timeFrame: Postoperative 24 hours period
Secondary outcomes:
measure: The use of rescue analgesia (number of participants and rate of tramodol using)
timeFrame: Postoperative 24 hours period
measure: Patient satisfaction
timeFrame: Postoperative at 24th hour
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Mugla Sıtkı Kocman University Hospital
Study officials:
References:
citation: Atalay YO, Mursel E, Ciftci B, Iptec G. Clavipectoral Fascia Plane Block for Analgesia after Clavicle Surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2019 Dec;66(10):562-563. doi: 10.1016/j.redar.2019.06.006. Epub 2019 Nov 11. No abstract available. English, Spanish.
citation: Atalay YO, Ciftci B, Ekinci M, Yesiltas S. The effectiveness of clavipectoral fascia plane block for analgesia after clavicle surgery: a report of five cases. Minerva Anestesiol. 2020 Sep;86(9):992-993. doi: 10.23736/S0375-9393.20.14503-6. Epub 2020 May 18. No abstract available.
citation: Kukreja P, Davis CJ, MacBeth L, Feinstein J, Kalagara H. Ultrasound-Guided Clavipectoral Fascial Plane Block for Surgery Involving the Clavicle: A Case Series. Cureus. 2020 Jul 8;12(7):e9072. doi: 10.7759/cureus.9072.
citation: Magalhaes J, Segura-Grau E. Single puncture clavipectoral fascial block as a potential effective analgesic strategy for clavicle surgery. J Clin Anesth. 2020 Dec;67:110062. doi: 10.1016/j.jclinane.2020.110062. Epub 2020 Sep 23. No abstract available.