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

NCT03279679 | Unknown

• 1 other identifier: TJ-IRB20170702
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Brachial Plexus Block

Keywords

costoclavicular; paracoracoid; brachial plexus

Outcome Measures

Primary Outcomes (1)

• MEV

  minimum effective volume regional anesthetic need for a successful infraclavicular block

  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.

Secondary Outcomes (1)

• performance time

  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

Study Arms (2)

costoclavicular group

EXPERIMENTAL

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; Device: Ultrasound; Drug: Ropivacaine

paracoracoid group

OTHER

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; Device: Ultrasound; Drug: Ropivacaine

Interventions

costoclavicular infraclavicular block PROCEDURE

Infraclavicular brachial plexus block will be performed through new costoclavicular space approach under realtime ultrasound guidance with 0.5% ropivacaine

costoclavicular group

paracoracoid infraclavicular block PROCEDURE

Infraclavicular brachial plexus block will be performed through traditional paracoracoid approach under realtime ultrasound guidance with 0.5% ropivacaine

paracoracoid group

Ultrasound DEVICE

All the nerve blocks will be performed under realtime ultrasound guidance

costoclavicular group; paracoracoid group

Ropivacaine DRUG

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

costoclavicular group; paracoracoid group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Related Publications (9)

• Albrecht E, Mermoud J, Fournier N, Kern C, Kirkham KR. A systematic review of ultrasound-guided methods for brachial plexus blockade. Anaesthesia. 2016 Feb;71(2):213-27. doi: 10.1111/anae.13347. Epub 2015 Dec 16.

  PMID: 26670119 BACKGROUND

• Park SK, Lee SY, Kim WH, Park HS, Lim YJ, Bahk JH. Comparison of Supraclavicular and Infraclavicular Brachial Plexus Block: A Systemic Review of Randomized Controlled Trials. Anesth Analg. 2017 Feb;124(2):636-644. doi: 10.1213/ANE.0000000000001713.

  PMID: 27828793 BACKGROUND

• Sauter AR, Smith HJ, Stubhaug A, Dodgson MS, Klaastad O. Use of magnetic resonance imaging to define the anatomical location closest to all three cords of the infraclavicular brachial plexus. Anesth Analg. 2006 Dec;103(6):1574-6. doi: 10.1213/01.ane.0000242529.96675.fd.

  PMID: 17122242 BACKGROUND

• Tran DQ, Dugani S, Dyachenko A, Correa JA, Finlayson RJ. Minimum effective volume of lidocaine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):190-4. doi: 10.1097/AAP.0b013e31820d4266.

  PMID: 21270721 BACKGROUND

• Tran DQ, Bertini P, Zaouter C, Munoz L, Finlayson RJ. A prospective, randomized comparison between single- and double-injection ultrasound-guided infraclavicular brachial plexus block. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):16-21. doi: 10.1097/AAP.0b013e3181c7717c.

  PMID: 20048654 BACKGROUND

• Flohr-Madsen S, Ytrebo LM, Kregnes S, Wilsgaard T, Klaastad O. Minimum effective volume of ropivacaine 7.5 mg/ml for an ultrasound-guided infraclavicular brachial plexus block. Acta Anaesthesiol Scand. 2013 Apr;57(4):495-501. doi: 10.1111/aas.12078. Epub 2013 Feb 18.

  PMID: 23418881 BACKGROUND

• Sala-Blanch X, Reina MA, Pangthipampai P, Karmakar MK. Anatomic Basis for Brachial Plexus Block at the Costoclavicular Space: A Cadaver Anatomic Study. Reg Anesth Pain Med. 2016 May-Jun;41(3):387-91. doi: 10.1097/AAP.0000000000000393.

  PMID: 27035461 BACKGROUND

• Leurcharusmee P, Elgueta MF, Tiyaprasertkul W, Sotthisopha T, Samerchua A, Gordon A, Aliste J, Finlayson RJ, Tran DQH. A randomized comparison between costoclavicular and paracoracoid ultrasound-guided infraclavicular block for upper limb surgery. Can J Anaesth. 2017 Jun;64(6):617-625. doi: 10.1007/s12630-017-0842-z. Epub 2017 Feb 15.

  PMID: 28205117 BACKGROUND

• Petrar SD, Seltenrich ME, Head SJ, Schwarz SK. Hemidiaphragmatic paralysis following ultrasound-guided supraclavicular versus infraclavicular brachial plexus blockade: a randomized clinical trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):133-8. doi: 10.1097/AAP.0000000000000215.

  PMID: 25650633 BACKGROUND

MeSH Terms

Interventions

Ultrasonography; Ropivacaine

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Wei Mei, MD

  Department of anesthesiology, Tongji hospital, Huazhong University of Science and Technology

  STUDY DIRECTOR

Central Study Contacts

Wei Mei, MD

CONTACT

130-0616-2508; wmei@tjh.tjmu.edu.cn

Shuguang Yang, MD

CONTACT

150-7107-8161; yangsuperpro@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD Vice-Director of Anestheiology Department, Tongji hospital

Model Details: costoclavicular group and paracoracoid group

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 12, 2017
• Study Start: October 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share