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

Medipol University

Status: Withdrawn

Conditions: Clavicle Fracture; Clavicle Injury

Treatments: Other: "Ibuprofen", "Dorifen®"; "Fentanyl", "Talinat®", ''Patient Controlled Analgesia Device''

Study type: Interventional

Funder types: Other

Identifiers

NCT04332497

Medipol Hospital 11

Details and patient eligibility

About

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).

Full 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).

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

Group CPB = Clavipectoral fascia plane block group

Active Comparator group

Description:

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.

Treatment:

Other: "Ibuprofen", "Dorifen®"; "Fentanyl", "Talinat®", ''Patient Controlled Analgesia Device''

Other: "Ibuprofen", "Dorifen®"; "Fentanyl", "Talinat®", ''Patient Controlled Analgesia Device''

Group C = Control group

No Intervention group

Description:

Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.

Group ISCB = ISCB group

Active Comparator group

Description:

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.

Treatment:

Other: "Ibuprofen", "Dorifen®"; "Fentanyl", "Talinat®", ''Patient Controlled Analgesia Device''

Other: "Ibuprofen", "Dorifen®"; "Fentanyl", "Talinat®", ''Patient Controlled Analgesia Device''