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Comparison Between Costoclavicular and Paracoracoid Ultrasound-guided Infraclavicular Block for Forearm Surgery

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ClinicalTrials.gov Identifier: NCT03279679
Recruitment Status : Unknown
Verified September 2017 by Wei Mei, Huazhong University of Science and Technology.
Recruitment status was:  Not yet recruiting
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Wei Mei, Huazhong University of Science and Technology

Brief Summary:
The costoclavicular space block technique is a new developed approach of ultrasound-guided infraclavicular brachial plexus block(USG-ICB) in last two years and has not been studied much yet. The paracoracoid approach serves as a standard and traditional method for USG-ICB in clinical practice, easy to learn and perform. The investigators set this parallel controlled dose-finding trial to work out the MEV with 0.5% ropivacaine of both two approaches above for forearm surgery and compare the performance time between them, providing reasonable evidence for clinical choice.

Condition or disease Intervention/treatment Phase
Brachial Plexus Block Procedure: costoclavicular infraclavicular block Procedure: paracoracoid infraclavicular block Device: Ultrasound Drug: Ropivacaine Not Applicable

Detailed Description:
The costoclavicular space block technique is a new developed approach of ultrasound-guided infraclavicular brachial plexus block(USG-ICB) in last two years and has not been studied much yet. USG-ICB represents an attractive option for upper-limb surgery at or below the elbow joint with similar success rate and fewer adverse effects compared with ultrasound-guided supraclavicular block. The paracoracoid approach serves as a standard and traditional method for USG-ICB in clinical practice, easy to learn and perform. However, the minimum effective volume(MEV)of this approach has been studied by different investigators with different regional anesthetics or its mixture, and specially, the 95% MEV result of this approach is more than 30ml in all related researches which is still a large volume. According to the investigators' experience in using the costoclavicular space technique for forearm surgery, it usually can get a comparable sensation and motor block effect by no more than 25ml. Recently, there was a clinical randomized control study which compared the costoclavicular and paracoracoid USG-ICB for upper limb surgery using a 35ml-mixture of 1% lidocaine-0.25% bupivacaine with epinephrine 5 ug/ml and came to the conclusions: two groups resulted in similar onset times and no intergroup difference were found in terms of performance time and success rate. However, 35ml is a much larger regional anesthetic volume than what we used in routine brachial plexus block. So, we set this parallel controlled dose-finding trial to work out the MEV with 0.5% ropivacaine of both approaches above for forearm surgery and compare the performance time between them, providing reasonable evidence for clinical choice. Patients enrolled in this study will be assigned to costoclavicular group and paracoracoid group and in each group, the volume of local anesthetic applied to patients start with 30ml, and then decreased by 2.5ml for next patient when the previous block is successful, otherwise increased by 2.5ml when failed,which is also called a staircase up-and-down method usually applied in dose-finding research of nerve block. After certain reflections of the local anesthetic volume sequential line graph, the minimum effective volume could be calculated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: costoclavicular group and paracoracoid group
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Minimum Effective Volume With 0.5% Ropivacaine Between Costoclavicular and Paracoracoid Ultrasound-guided Infraclavicular Block for Forearm Surgery
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: costoclavicular group
patients in this group are assigned to receive ultrasound-guided costoclavicular infraclavicular block with 0.5% ropivacaine for upper limb surgery at elbow joint and below
Procedure: costoclavicular infraclavicular block
Infraclavicular brachial plexus block will be performed through new costoclavicular space approach under realtime ultrasound guidance with 0.5% ropivacaine

Device: Ultrasound
All the nerve blocks will be performed under realtime ultrasound guidance

Drug: Ropivacaine
0.5% ropivacaine will be used for the brachial plexus block in both groups.

paracoracoid group
patients in this group are assigned to receive ultrasound-guided paracoracoid infraclavicular block with 0.5% ropivacaine for upper limb surgery at elbow joint and below
Procedure: paracoracoid infraclavicular block
Infraclavicular brachial plexus block will be performed through traditional paracoracoid approach under realtime ultrasound guidance with 0.5% ropivacaine

Device: Ultrasound
All the nerve blocks will be performed under realtime ultrasound guidance

Drug: Ropivacaine
0.5% ropivacaine will be used for the brachial plexus block in both groups.




Primary Outcome Measures :
  1. MEV [ Time Frame: The anesthesia effect of the block with a specified volume fo local anesthetic will be assessed at 30 min after the nerve block finished, the MEV will be calculated after all. ]
    minimum effective volume regional anesthetic need for a successful infraclavicular block


Secondary Outcome Measures :
  1. performance time [ Time Frame: from the time point when ultrasound probe touches with patients' skin to the end when local anesthetic is injected through the needle, which is usually up to ten minutes ]
    time needed for the block performance



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA status 1 to 3
  • BMI 20-35
  • Scheduled for surgery at elbow joint or below

Exclusion Criteria:

  • Inability to consent to the study
  • Preexisting neuropathy,coagulopathy,COPD
  • Hepatic or renal failure
  • Allergy to local anesthetics
  • Pregnancy
  • Prior surgery in infraclavicular region

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): NCT03279679


Contacts
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Contact: Wei Mei, MD 130-0616-2508 wmei@tjh.tjmu.edu.cn
Contact: Shuguang Yang, MD 150-7107-8161 yangsuperpro@163.com

Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
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Study Director: Wei Mei, MD Department of anesthesiology, Tongji hospital, Huazhong University of Science and Technology
Publications:

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Responsible Party: Wei Mei, PhD, MD Vice-Director of Anestheiology Department, Tongji hospital, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03279679    
Other Study ID Numbers: TJ-IRB20170702
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Wei Mei, Huazhong University of Science and Technology:
costoclavicular
paracoracoid
brachial plexus
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents