Clavipectoral Fascia Plane Block Versus Interscalen Brachial Plexus Block for Clavicle Surgery

Not Applicable

Withdrawn

• Conditions: Clavicle Injury; Clavicle Fracture
• Interventions: Other: "Ibuprofen", "Dorifen®"; "Fentanyl", "Talinat®", ''Patient Controlled Analgesia Device''

• Registration Number: NCT04332497
• Lead Sponsor: Medipol University

Brief Summary

The pain after clavicle fracture surgery may be managed with combined superficial cervical plexus-interscalene block and recently clavipectoral fascia plane block (CPB). CPB was defined by Valdes in 2017 firstly. It may be used for postoperative analgesia after clavicle surgery. CPB may be an alternative to interscalene brachial plexus block.

The aim of this study is to compare the efficacy of the US-guided CPB and ISCB for postoperative analgesia management after clavicle surgery. The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Detailed Description

Clavicle fracture is common in men and children after a direct fall on shoulder during sport activity such as cycling or an injury during a traffic accident. The pain after clavicle fracture surgery may be managed with combined superficial cervical plexus-interscalene block (ISCB) and recently clavipectoral fascia plane block (CPB). 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.

The aim of this study is to compare the efficacy of the US-guided CPB and ISCB for postoperative analgesia management after clavicle surgery. The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Study Timeline

• Study First Submitted: 2020-03-28
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-02
• Study Start: 2020-04-10
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• history of bleeding diathesis,
• receiving anticoagulant treatment,
• known local anesthetics and opioid allergy,
• infection of the skin at the site of the needle puncture,
• pregnancy or lactation,
• patients who do not accept the procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group CPB = Clavipectoral fascia plane block group	"Ibuprofen", "Dorifen®"; "Fentanyl", "Talinat®", ''Patient Controlled Analgesia Device''	In group CPB, CPB will be performed with patients in the supine position. The probe will be placed on the anterior border of the medial third of the clavicle. A 22-gauge block needle will be inserted in a caudal to cephalic direction, the periosteum of the clavicle and the surrounding fascia will be visualized, 20 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 ISCB = ISCB group	"Ibuprofen", "Dorifen®"; "Fentanyl", "Talinat®", ''Patient Controlled Analgesia Device''	In group ISCB, ISCB will be performed with patients in the supin position. US probe will be placed in transverse plane at the level of cricoid cartilage. The prob will be moved laterally when the artery is visualized. The needle will be inserted in a medial-to-lateral direction after the brachial plexus between the scalen muscles is visualized. Then, 5 ml normal saline will be enjected for correction of the needle with in-plane technique. Following confirmation of the correct position of the needle 30 ml %0.25 bupivacaine will be administered for block.

Primary Outcome Measures

Name	Time	Method
Opioid consumption for postoperative 24 hours period according to the patient controlled analgesia device	Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.	The primary aim is to compare postoperative opioid consumption

Secondary Outcome Measures

Name	Time	Method
Pain scores (Visual analogue scores-VAS)	Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours.	Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores will be recorded

Trial Locations

Locations (1)

Istanbul Medipol University Hospital; 🇹🇷 Istanbul, Bagcilar, Turkey