The Effectiveness of Clavipectoral Fascia Plane Block for Clavicle Surgery

NCT ID: NCT05268874

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-18
• Study Completion Date: 2022-09-16

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

Conditions

Clavicle Fracture; Clavicle Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group Clavipectoral = Clavipectoral block group

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.

Group Type: ACTIVE_COMPARATOR

Clavipectoral block

Intervention Type: OTHER

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.

Group Control = Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Bahadir Ciftci

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mugla Sıtkı Kocman University Hospital

Muğla, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 31727320 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32420714 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32782888 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32979611 (View on PubMed)

Other Identifiers

Mugla Sitki Kocman University

Identifier Type: -

Identifier Source: org_study_id