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

NCT04332497 | Withdrawn

• 1 other identifier: Medipol Hospital 11
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Clavicle Fracture; Clavicle Injury

Keywords

Clavicle fracture; Clavipectoral fascia plane block; Postoperative analgesia; Interscalene block

Outcome Measures

Primary Outcomes (1)

• Opioid consumption for postoperative 24 hours period according to the patient controlled analgesia device

  The primary aim is to compare postoperative opioid consumption

  Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.

Secondary Outcomes (1)

• Pain scores (Visual analogue scores-VAS)

  Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours.

Study Arms (3)

Group CPB = Clavipectoral fascia plane block group

ACTIVE COMPARATOR

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.

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

Group C = Control group

NO INTERVENTION

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

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.

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

Interventions

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

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 CPB = Clavipectoral fascia plane 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:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (3)

• 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

• Ince I, Kilicaslan A, Roques V, Elsharkawy H, Valdes L. Ultrasound-guided clavipectoral fascial plane block in a patient undergoing clavicular surgery. J Clin Anesth. 2019 Dec;58:125-127. doi: 10.1016/j.jclinane.2019.07.011. Epub 2019 Aug 1. No abstract available.

  PMID: 31377668 BACKGROUND

• Ueshima H, Ishihara T, Hosokawa M, Otake H. RETRACTED: Clavipectoral fascial plane block in a patient with dual antiplatelet therapy undergoing emergent clavicular surgery. J Clin Anesth. 2020 May;61:109648. doi: 10.1016/j.jclinane.2019.109648. Epub 2019 Nov 13. No abstract available.

  PMID: 31732427 BACKGROUND

MeSH Terms

Interventions

Ibuprofen; Fentanyl

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary researcher

Model Details: There are three models for this study. Patients will be randomly divided into three groups (Group CPB = CPB group, Group ISCB = ISCB group, Group C = Control group), before entering the operating room.

Study Record Dates

• First Submitted: March 28, 2020
• First Posted: April 2, 2020
• Study Start: April 10, 2020
• Primary Completion: December 20, 2021
• Study Completion: December 30, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)