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

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ClinicalTrials.gov Identifier: NCT04332497
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Bahadir Ciftci, 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).


Condition or disease Intervention/treatment Phase
Clavicle Fracture Clavicle Injury Other: "Ibuprofen", "Dorifen®"; "Fentanyl", "Talinat®", ''Patient Controlled Analgesia Device'' Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.
Primary Purpose: Treatment
Official Title: Comparison of Ultrasound-guided Clavipectoral Fascia Plane Block and Interscalen Brachial Plexus Block for Analgesia After Clavicle Surgery
Actual Study Start Date : April 10, 2020
Estimated Primary Completion Date : November 20, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group CPB = Clavipectoral fascia plane block group
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''
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.

No Intervention: Group C = Control group
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.
Active Comparator: Group ISCB = ISCB group
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''
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




Primary Outcome Measures :
  1. Opioid consumption for postoperative 24 hours period according to the patient controlled analgesia device [ Time Frame: 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 :
  1. Pain scores (Visual analogue scores-VAS) [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04332497


Contacts
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Contact: Bahadir Ciftci +905325034428 bciftci@medipol.edu.tr
Contact: Mürsel Ekinci +905067137596 mekinci@medipol.edu.tr

Locations
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Turkey
Istanbul Medipol University Hospital Recruiting
Istanbul, Bagcilar, Turkey, 34070
Contact: Bahadir Ciftci, MD    +905325034428    bciftci@medipol.edu.tr   
Contact: Mürsel Ekinci, MD    +905067137596    drmurselekinci@gmail.com   
Sponsors and Collaborators
Medipol University
Publications:
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Responsible Party: Bahadir Ciftci, Primary researcher, Medipol University
ClinicalTrials.gov Identifier: NCT04332497    
Other Study ID Numbers: Medipol Hospital 11
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bahadir Ciftci, Medipol University:
Clavicle fracture
Clavipectoral fascia plane block
Postoperative analgesia
Interscalene block
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries
Ibuprofen
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action