The Effectiveness of Clavipectoral Fascia Plane Block for Clavicle Surgery

Clavicle Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05268874
• Other study ID #: Mugla Sitki Kocman University
• Status: Completed
• Phase: N/A
• Start date: March 18, 2022
• Est. completion date: September 16, 2022

Study information

• Verified date: September 2022
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 16, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Clavicle Fracture
• Clavicle Injury

Intervention

Other:
• Clavipectoral 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.

Locations

Country	Name	City	State
Turkey	Mugla Sitki Kocman University Hospital	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. English, Spanish. — View 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. — View Citation

Magalhães 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain scores (NRS)	The primary outcome is the NRS at postoperative 8th hour	Postoperative 24 hours period
Secondary	The use of rescue analgesia (number of participants and rate of tramodol using)	Tramodol using	Postoperative 24 hours period
Secondary	Patient satisfaction	Patient satisfaction will be evaluated with seven item Likert scala	Postoperative at 24th hour