The Effectiveness of Clavipectoral Fascia Plane Block for Clavicle Surgery

Not Applicable

Completed

• Conditions: Clavicle Fracture; Clavicle Injury
• Interventions: Other: Clavipectoral block

• Registration Number: NCT05268874
• Lead Sponsor: Medipol University

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

Study Timeline

• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-24
• Study First Posted: 2022-03-07
• Study Start: 2022-03-18
• Status Verified: 2022-09
• Primary Completion: 2022-09-16
• Study Completion: 2022-09-16
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Clavipectoral = Clavipectoral block group	Clavipectoral block	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.

Primary Outcome Measures

Name	Time	Method
Postoperative pain scores (NRS)	Postoperative 24 hours period	The primary outcome is the NRS at postoperative 8th hour

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	Postoperative at 24th hour	Patient satisfaction will be evaluated with seven item Likert scala
The use of rescue analgesia (number of participants and rate of tramodol using)	Postoperative 24 hours period	Tramodol using

Trial Locations

Locations (1)

Mugla Sıtkı Kocman University Hospital; 🇹🇷 Muğla, Turkey