- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04332497
Clavipectoral Fascia Plane Block Versus Interscalen Brachial Plexus Block for Clavicle Surgery
Comparison of Ultrasound-guided Clavipectoral Fascia Plane Block and Interscalen Brachial Plexus Block for Analgesia After Clavicle Surgery
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).
Study Overview
Status
Conditions
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bagcilar
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Istanbul, Bagcilar, Turkey, 34070
- Istanbul Medipol University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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
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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.
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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.
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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.
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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The primary aim is to compare postoperative opioid consumption
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Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain scores (Visual analogue scores-VAS)
Time Frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours.
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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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Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Fractures, Bone
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Fentanyl
- Ibuprofen
Other Study ID Numbers
- Medipol Hospital 11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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