The Study of Regional Hemodynamic Changes After Specific Brachial Plexus Block by Ultrasound Guidance

NCT02139982 | Completed Phase 1 Results

• 1 other identifier: 2009A145-1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1 Sympathetic block leads to vasodilatation and increases in blood flow. However, regional hemodynamic changes of radial and ulnar artery after specific nerve block of brachial plexus remains unclear. The aim of the study is to assess the effect of specific nerve block of brachial plexus on hemodynamics of upper extremity, and provides evidence for further research in patient undergoing microvascular surgery. Phase 2 There is no literature about dose-finding studies of sympathetic block after brachial plexus block. Little is known regarding the relationship between concentration of local anaesthetic and vasodilation of upper extremity. The aim of this randomized, double-blind, prospective dose-response study is to determine the ED50 and ED95 of ropivacaine in sympathetic block of upper extremity after supraclavicular block

Conditions

Upper Limb Nerve Block

Keywords

hemodynamics; anaesthetics; brachial plexus; peripheral nerves; skin temperature; sympathetic nervous system; dose-response relationship

Outcome Measures

Primary Outcomes (3)

• Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)

  These parameters included peak systolic velocity (PSV, cm/s), end-diastolic velocity (EDV, cm/s), time average maximum velocity (TAMAX),and was measured by Pulsed-wave Doppler(PWD) ultrasound.

  baseline(t0), 30 min after specific nerve block(t1), 30 min after brachial plexus block(t2)

• Changes in Hemodynamic Parameters of Brachial Artery From Baseline to 30min After Brachial Plexus Block(Phase 2)

  These parameters included peak systolic velocity (PSV, cm/s), end-diastolic velocity (EDV, cm/s), time average maximum velocity (TAMAX), resistance index (RI), and pulsatility index (PI),The cross-sectional area of the artery imaging.Blood flow (BF) = TAMAX× CSA×60s. Relative ratio of hemodymanic parameter=30 min after brachial plexus block divide by baseline

  baseline, 30 min after brachial plexus block

• Changes in Cross-sectional Area of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)

  The cross-sectional area(CSA, cm2) of Radial/ulnar Artery was assessed with B-mode imaging. Probe was kept perpendicular to the long axis of the artery to obtain the largest oval arterial section. The image at end diastole was chosen and measured with the cine loop.

  baseline(t0), 30 min after specific nerve block(t1), 30 min after brachial plexus block(t2)

Secondary Outcomes (3)

• Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)

  baseline, 30 min after specific nerve block, 30 min after brachial plexus block

• Success of Brachial Plexus Block ( Phase 2)

  30 min after brachial plexus block

• Changes in Skin Temperature From Baseline to 30min After Brachial Plexus Block(Phase 2)

  Baseline,30 min after brachial plexus block

Study Arms (10)

group MC(phase 1)

OTHER

specific nerve block:musculocutaneous nerve block

Procedure: specific nerve block

group UL( phase 1)

OTHER

specific nerve block:ulnar nerve block

Procedure: specific nerve block

group RA (phase 1)

OTHER

specific nerve block:radial nerve block

Procedure: specific nerve block

group ME (phase 1)

OTHER

specific nerve block:median nerve block

Procedure: specific nerve block

group A(phase 2)

EXPERIMENTAL

30ml ropivacaine 0.125%

Drug: ropivacaine

group B(phase 2)

EXPERIMENTAL

30ml ropivacaine 0.2%

Drug: ropivacaine

group C(phase 2)

EXPERIMENTAL

30ml ropivacaine 0.25%

Drug: ropivacaine

group D(phase 2)

EXPERIMENTAL

30ml ropivacaine 0.375%

Drug: ropivacaine

group E(phase 2)

EXPERIMENTAL

30ml ropivacaine 0.5%

Drug: ropivacaine

group F(phase 2)

EXPERIMENTAL

30ml ropivacaine 0.75%

Drug: ropivacaine

Interventions

specific nerve block PROCEDURE

specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region

group MC(phase 1); group ME (phase 1); group RA (phase 1); group UL( phase 1)

ropivacaine DRUG

Different concentration of ropivacaine

Also known as: Naropin

group A(phase 2); group B(phase 2); group C(phase 2); group D(phase 2); group E(phase 2); group F(phase 2)

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologist physical status I-III patients
• aged 18-70 yr
• weighing 40-80 kg

You may not qualify if:

• infection at the site of needle insertion
• coagulopathy
• international normalized ratio \>1.4
• platelet count \<80×109 litre-1
• allergy to local anaesthetics
• peripheral neurological disease
• peripheral vascular disease
• patients do not agree to sign the informed consent.

Sponsors & Collaborators

• Wenzhou Medical University: lead
• Health and Family Planning Commission of Zhejiang Province, China: collaborator

Study Sites (1)

The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

Location

Related Publications (21)

• Li J, Karmakar MK, Li X, Kwok WH, Ngan Kee WD. Regional hemodynamic changes after an axillary brachial plexus block: a pulsed-wave Doppler ultrasound study. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):111-8. doi: 10.1097/AAP.0b013e318234007e.

  PMID: 22030722 BACKGROUND

• Shemesh D, Olsha O, Orkin D, Raveh D, Goldin I, Reichenstein Y, Zigelman C. Sympathectomy-like effects of brachial plexus block in arteriovenous access surgery. Ultrasound Med Biol. 2006 Jun;32(6):817-22. doi: 10.1016/j.ultrasmedbio.2006.02.1420.

  PMID: 16785004 BACKGROUND

• Hermanns H, Braun S, Werdehausen R, Werner A, Lipfert P, Stevens MF. Skin temperature after interscalene brachial plexus blockade. Reg Anesth Pain Med. 2007 Nov-Dec;32(6):481-7. doi: 10.1016/j.rapm.2007.06.392.

  PMID: 18035293 BACKGROUND

• Sahin L, Gul R, Mizrak A, Deniz H, Sahin M, Koruk S, Cesur M, Goksu S. Ultrasound-guided infraclavicular brachial plexus block enhances postoperative blood flow in arteriovenous fistulas. J Vasc Surg. 2011 Sep;54(3):749-53. doi: 10.1016/j.jvs.2010.12.045. Epub 2011 Mar 2.

  PMID: 21367563 BACKGROUND

• Hingorani AP, Ascher E, Gupta P, Alam S, Marks N, Schutzer RW, Multyala M, Shiferson A, Yorkovich W, Jacob T, Salles-Cunha S. Regional anesthesia: preferred technique for venodilatation in the creation of upper extremity arteriovenous fistulae. Vascular. 2006 Jan-Feb;14(1):23-6. doi: 10.2310/6670.2006.00006.

  PMID: 16849019 BACKGROUND

• Breschan C, Kraschl R, Jost R, Marhofer P, Likar R. Axillary brachial plexus block for treatment of severe forearm ischemia after arterial cannulation in an extremely low birth-weight infant. Paediatr Anaesth. 2004 Aug;14(8):681-4. doi: 10.1111/j.1460-9592.2004.01282.x.

  PMID: 15283829 BACKGROUND

• Ebert B, Braunschweig R, Reill P. [Quantification of variations in arm perfusion after plexus anesthesia with color doppler sonography]. Anaesthesist. 1995 Dec;44(12):859-62. doi: 10.1007/s001010050222. German.

  PMID: 8594960 BACKGROUND

• Badal JJ, Kiesau A, Boyle P. Effects of median nerve block on radial artery diameter and peak velocity. Local Reg Anesth. 2010;3:5-10. doi: 10.2147/lra.s9524. Epub 2010 Feb 23.

  PMID: 22915862 BACKGROUND

• Van der Werff JF, Medici G, Hovius SE, Kusuma A. Axillary plexus blockade in microvascular surgery, a steal phenomenon? Microsurgery. 1995;16(3):141-3. doi: 10.1002/micr.1920160305.

  PMID: 7637621 BACKGROUND

• Sonntag BV, Murphy RX Jr, Chernofsky MA, Chowdary RP. Microvascular steal phenomenon in lower extremity reconstruction. Ann Plast Surg. 1995 Mar;34(3):336-9; discussion 339-40. doi: 10.1097/00000637-199503000-00020.

  PMID: 7598395 BACKGROUND

• Lange KH, Jansen T, Asghar S, Kristensen PL, Skjonnemand M, Norgaard P. Skin temperature measured by infrared thermography after specific ultrasound-guided blocking of the musculocutaneous, radial, ulnar, and median nerves in the upper extremity. Br J Anaesth. 2011 Jun;106(6):887-95. doi: 10.1093/bja/aer085. Epub 2011 Apr 6.

  PMID: 21474476 BACKGROUND

• Lehtipalo S, Winso O, Koskinen LO, Johansson G, Biber B. Cutaneous sympathetic vasoconstrictor reflexes for the evaluation of interscalene brachial plexus block. Acta Anaesthesiol Scand. 2000 Sep;44(8):946-52. doi: 10.1034/j.1399-6576.2000.440809.x.

  PMID: 10981571 BACKGROUND

• Morgan RF, Reisman NR, Wilgis EF. Anatomic localization of sympathetic nerves in the hand. J Hand Surg Am. 1983 May;8(3):283-8. doi: 10.1016/s0363-5023(83)80161-0.

  PMID: 6875230 BACKGROUND

• Campero M, Verdugo RJ, Ochoa JL. Vasomotor innervation of the skin of the hand: a contribution to the study of human anatomy. J Anat. 1993 Jun;182 ( Pt 3)(Pt 3):361-8.

  PMID: 8226291 BACKGROUND

• Kurt E, Ozturk S, Isik S, Zor F. Continuous brachial plexus blockade for digital replantations and toe-to-hand transfers. Ann Plast Surg. 2005 Jan;54(1):24-7. doi: 10.1097/01.sap.0000139568.57928.86.

  PMID: 15613878 BACKGROUND

• van den Berg B, Berger A, van den Berg E, Zenz M, Brehmeier G, Tizian C. [Continuous plexus anesthesia to improve circulation in peripheral microvascular interventions]. Handchir Mikrochir Plast Chir. 1983 Jun;15(2):101-4. German.

  PMID: 6884859 BACKGROUND

• Fredrickson MJ, Smith KR, Wong AC. Importance of volume and concentration for ropivacaine interscalene block in preventing recovery room pain and minimizing motor block after shoulder surgery. Anesthesiology. 2010 Jun;112(6):1374-81. doi: 10.1097/ALN.0b013e3181d6929d.

  PMID: 20460999 BACKGROUND

• Casati A, Baciarello M, Di Cianni S, Danelli G, De Marco G, Leone S, Rossi M, Fanelli G. Effects of ultrasound guidance on the minimum effective anaesthetic volume required to block the femoral nerve. Br J Anaesth. 2007 Jun;98(6):823-7. doi: 10.1093/bja/aem100. Epub 2007 May 3.

  PMID: 17478453 BACKGROUND

• Gupta PK, Pace NL, Hopkins PM. Effect of body mass index on the ED50 volume of bupivacaine 0.5% for supraclavicular brachial plexus block. Br J Anaesth. 2010 Apr;104(4):490-5. doi: 10.1093/bja/aeq017. Epub 2010 Feb 18.

  PMID: 20167584 BACKGROUND

• Li T, Ye Q, Wu D, Li J, Yu J. Dose-response studies of Ropivacaine in blood flow of upper extremity after supraclavicular block: a double-blind randomized controlled study. BMC Anesthesiol. 2017 Dec 2;17(1):161. doi: 10.1186/s12871-017-0447-7.

  PMID: 29197338 DERIVED

• Li T, Ye Q, Yeung J, Wu D, Li J, Lian Q, Gao F. Regional haemodynamic changes after selective block of the four principal nerves in the arm: A double-blind randomised controlled study. Eur J Anaesthesiol. 2016 Aug;33(8):599-601. doi: 10.1097/EJA.0000000000000433. No abstract available.

  PMID: 26986777 DERIVED

Related Links

• The Second Affiliated Hospital \& Yuying Children hospital of Wenzhou Medical University

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Ting Li
• Organization: The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University

liting1021@aliyun.com

008613587876896

Study Officials

• Ting Li, M.D.

  Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 16, 2014
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 1, 2014
• Results First Posted: July 24, 2014

Record last verified: 2014-07

Locations

CN (1)