The Effectiveness of Clavipectoral Fascia Plane Block for Clavicle Surgery

NCT05268874 | Completed

• 1 other identifier: Mugla Sitki Kocman University
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Clavicle Fracture; Clavicle Injury

Keywords

Clavicle surgery; Postoperative pain management; Clavipectoral fascia plane block

Outcome Measures

Primary Outcomes (1)

• Postoperative pain scores (NRS)

  The primary outcome is the NRS at postoperative 8th hour

  Postoperative 24 hours period

Secondary Outcomes (2)

• The use of rescue analgesia (number of participants and rate of tramodol using)

  Postoperative 24 hours period

• Patient satisfaction

  Postoperative at 24th hour

Study Arms (2)

Group Clavipectoral = Clavipectoral block group

ACTIVE COMPARATOR

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.

Other: Clavipectoral block

Group Control = Control group

NO INTERVENTION

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.

Interventions

Clavipectoral block 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 Clavipectoral = Clavipectoral block group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) classification I-II
• Scheduled for clavicle surgery under general anesthesia

You may not qualify if:

• bleeding diathesis,
• anticoagulation,
• thorax wall abnormalities
• study drug allergy,
• infection at the block area,
• pregnancy or lactation,
• patients who do not accept the procedure

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Mugla Sıtkı Kocman University Hospital

Muğla, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 31727320 BACKGROUND

• 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.

  PMID: 32420714 BACKGROUND

• 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.

  PMID: 32782888 BACKGROUND

• 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.

  PMID: 32979611 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor and participant will be blinded to the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 7, 2022
• Study Start: March 18, 2022
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)