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

Primary Purpose

Clavicle Fracture, Clavicle Injury

Status
Withdrawn
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
"Ibuprofen", "Dorifen®"; "Fentanyl", "Talinat®", ''Patient Controlled Analgesia Device''
"Ibuprofen", "Dorifen®"; "Fentanyl", "Talinat®", ''Patient Controlled Analgesia Device''
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clavicle Fracture focused on measuring Clavicle fracture, Clavipectoral fascia plane block, Postoperative analgesia, Interscalene block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Istanbul Medipol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Active Comparator

Arm Label

Group CPB = Clavipectoral fascia plane block group

Group C = Control group

Group ISCB = ISCB group

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Opioid consumption for postoperative 24 hours period according to the patient controlled analgesia device
The primary aim is to compare postoperative opioid consumption

Secondary Outcome Measures

Pain scores (Visual analogue scores-VAS)
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

Full Information

First Posted
March 28, 2020
Last Updated
April 19, 2022
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT04332497
Brief Title
Clavipectoral Fascia Plane Block Versus Interscalen Brachial Plexus Block for Clavicle Surgery
Official Title
Comparison of Ultrasound-guided Clavipectoral Fascia Plane Block and Interscalen Brachial Plexus Block for Analgesia After Clavicle Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
no participants
Study Start Date
April 10, 2020 (Actual)
Primary Completion Date
December 20, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clavicle Fracture, Clavicle Injury
Keywords
Clavicle fracture, Clavipectoral fascia plane block, Postoperative analgesia, Interscalene block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group CPB = Clavipectoral fascia plane block group
Arm Type
Active Comparator
Arm 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.
Arm Title
Group C = Control group
Arm Type
No Intervention
Arm 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.
Arm Title
Group ISCB = ISCB group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
"Ibuprofen", "Dorifen®"; "Fentanyl", "Talinat®", ''Patient Controlled Analgesia Device''
Intervention 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.
Intervention Type
Other
Intervention Name(s)
"Ibuprofen", "Dorifen®"; "Fentanyl", "Talinat®", ''Patient Controlled Analgesia Device''
Intervention 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
Primary Outcome Measure Information:
Title
Opioid consumption for postoperative 24 hours period according to the patient controlled analgesia device
Description
The primary aim is to compare postoperative opioid consumption
Time Frame
Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Secondary Outcome Measure Information:
Title
Pain scores (Visual analogue scores-VAS)
Description
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
Time Frame
Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
State/Province
Bagcilar
ZIP/Postal Code
34070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not plan to share IPD
Citations:
PubMed Identifier
31727320
Citation
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.
Results Reference
background
PubMed Identifier
31377668
Citation
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.
Results Reference
background
PubMed Identifier
31732427
Citation
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.
Results Reference
background

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

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