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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03279679
Other study ID # TJ-IRB20170702
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 6, 2017
Last updated September 9, 2017
Start date October 2017
Est. completion date July 2018

Study information

Verified date September 2017
Source Huazhong University of Science and Technology
Contact Wei Mei, MD
Phone 130-0616-2508
Email wmei@tjh.tjmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date July 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Huazhong University of Science and Technology

References & 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. Review. — View Citation

Flohr-Madsen S, Ytrebø LM, Kregnes S, Wilsgaard T, Klaastad Ø. 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Sauter AR, Smith HJ, Stubhaug A, Dodgson MS, Klaastad Ø. 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. Erratum in: Anesth Analg. 2007 Mar;104(3):562. — View Citation

Tran DQ, Bertini P, Zaouter C, Muñoz 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 performance time time needed for the block performance 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
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