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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139982
Recruitment Status : Completed
First Posted : May 16, 2014
Results First Posted : July 24, 2014
Last Update Posted : August 1, 2014
Sponsor:
Collaborator:
Health and Family Planning Commission of Zhejiang Province, China
Information provided by (Responsible Party):
Ting Li, Wenzhou Medical University

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


Condition or disease Intervention/treatment Phase
Upper Limb Nerve Block Procedure: specific nerve block Drug: ropivacaine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Study of Regional Hemodynamic Changes After Specific Brachial Plexus Block by Ultrasound Guidance
Study Start Date : January 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
group MC(phase 1)
specific nerve block:musculocutaneous nerve block
Procedure: specific nerve block
specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region

group UL( phase 1)
specific nerve block:ulnar nerve block
Procedure: specific nerve block
specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region

group RA (phase 1)
specific nerve block:radial nerve block
Procedure: specific nerve block
specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region

group ME (phase 1)
specific nerve block:median nerve block
Procedure: specific nerve block
specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region

Experimental: group A(phase 2)
30ml ropivacaine 0.125%
Drug: ropivacaine
Different concentration of ropivacaine
Other Name: Naropin

Experimental: group B(phase 2)
30ml ropivacaine 0.2%
Drug: ropivacaine
Different concentration of ropivacaine
Other Name: Naropin

Experimental: group C(phase 2)
30ml ropivacaine 0.25%
Drug: ropivacaine
Different concentration of ropivacaine
Other Name: Naropin

Experimental: group D(phase 2)
30ml ropivacaine 0.375%
Drug: ropivacaine
Different concentration of ropivacaine
Other Name: Naropin

Experimental: group E(phase 2)
30ml ropivacaine 0.5%
Drug: ropivacaine
Different concentration of ropivacaine
Other Name: Naropin

Experimental: group F(phase 2)
30ml ropivacaine 0.75%
Drug: ropivacaine
Different concentration of ropivacaine
Other Name: Naropin




Primary Outcome Measures :
  1. 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) [ Time Frame: baseline(t0), 30 min after specific nerve block(t1), 30 min after brachial plexus block(t2) ]
    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.

  2. Changes in Hemodynamic Parameters of Brachial Artery From Baseline to 30min After Brachial Plexus Block(Phase 2) [ Time Frame: baseline, 30 min after brachial plexus block ]

    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


  3. 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) [ Time Frame: baseline(t0), 30 min after specific nerve block(t1), 30 min after brachial plexus block(t2) ]
    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.


Secondary Outcome Measures :
  1. Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1) [ Time Frame: baseline, 30 min after specific nerve block, 30 min after brachial plexus block ]
    Skin temperature(Ts) was measured at four different points within the cutaneous innervation areas of the musculocutaneous(lateral skin of forearm), ulnar(hypothenar region), radial (thumb-index web) and median(thenar) Specific points were located with skin marker to provide consistency of measurement.

  2. Success of Brachial Plexus Block ( Phase 2) [ Time Frame: 30 min after brachial plexus block ]
    Success of Brachial Plexus Block(BPB) was defined as the absence of sensation to in all innervation areas of above four nerves (musculocutaneous, ulnar, radial, and median nerves) 30min. after the BPB and no pain during the surgery.

  3. Changes in Skin Temperature From Baseline to 30min After Brachial Plexus Block(Phase 2) [ Time Frame: Baseline,30 min after brachial plexus block ]
    Skin temperature was measured at the thenar. change= 30min after brachial plexus block minus baseline



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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:

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

Exclusion Criteria:

  • 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.

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): NCT02139982


Locations
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China, Zhejiang
The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325027
Sponsors and Collaborators
Wenzhou Medical University
Health and Family Planning Commission of Zhejiang Province, China
Investigators
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Principal Investigator: Ting Li, M.D. Wenzhou Medical University
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ting Li, associate chief physician, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT02139982    
Other Study ID Numbers: 2009A145-1
First Posted: May 16, 2014    Key Record Dates
Results First Posted: July 24, 2014
Last Update Posted: August 1, 2014
Last Verified: July 2014
Keywords provided by Ting Li, Wenzhou Medical University:
hemodynamics
anaesthetics
brachial plexus
peripheral nerves
skin temperature
sympathetic nervous system
dose-response relationship
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