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

NCT ID: NCT02139982

Last Updated: 2014-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-12-31

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

Detailed Description

Phase 1 Brachial plexus block (BPB) is a widely used regional anesthetic technique for upper limb surgery. The effect of sympathetic block of BPB can leads to vasodilatation and increase blood flow and skin temperature in the ipsilateral upper limb. At the level of the axillary region, the sympathetic nerves innervating the radial and ulnar artery travel with the brachial plexus, but it is unclear which specific nerve: musculocutaneous, radial, ulnar, and median innervates radial or ulnar artery. Radial and ulnar artery and their branches are common donor or recipient vessels in the vascular reconstruction surgery and their hemodynamic changes may affect the blood flow of vascular anastomoses in vascular reconstruction. Sometimes, brachial plexus could be partially blocked intentionally or unintentionally, with the resultant regional hemodynamic changes unclear.

As the use of ultrasound guided peripheral nerve block getting increasingly popular, peripheral nerve can be blocked visually, with good accuracy and ease. It has made specific nerve block in the axillary region possible. Can specific nerve block increase the blood flow of target artery (radial or ulnar artery) and benefit microvascular surgery, or will it decrease the blood flow in other arteries and have a negative impact on microvascular surgery? In this study, the investigators will measure the hemodynamic changes of radial and ulnar artery after performing specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves respectively in patients without vascular disease. The aim is to assess the effect of specific nerve block on hemodynamics of upper extremity, and provided evidence for further research in patients undergoing microvascular surgery.

The subjects of study are patients undergoing upper extremity operation. All patients will be randomized into 4 groups according to the specific nerve block (SNB) of brachial plexus: group MC (musculocutaneous), group UL (ulnar), group RA (radial) and group ME (median). Patients are randomised to the four groups by random number(generated by computer) in sealed envelopes. Sample randomization will be done in four groups by random-number using sealed envelopes. Each patient will receive allocated SNB of brachial plexus (musculocutaneous, radial, ulnar, or median) followed by Axillary brachial plexus block successively using ultrasound guidance combined neurostimulation. All nerve blocks will be performed by a single dedicated anesthetist. A second investigator, who is blinded to the protocol and patient allocation, will perform the measurements.

Sensory blockade will be assessed by pinprick sensation (22 G needle) and compare with the opposite forearm/hand for normal, hypoesthesia or no sensation. Success of SNB is defined as only loss of sensation in the cutaneous distribution of the specific nerve (musculocutaneous, ulnar, radial, or median nerves) at 30min after SNB. If hypoesthesia or no sensation is detected in the innervation areas of any other nerve, the patient will be excluded. Success of BPB is defined as the absence of sensation to in all innervation areas of above four nerves 30min after the BPB.

Measurement of hemodynamic parameters The ulnar artery and radial artery is located at 1 cm proximal to the ulnar or radial styloid process. Specific points will be located with skin marker to provide consistency with all measurements taken. Hemodynamic parameters will is measured by Pulsed-wave Doppler (PWD) ultrasound. The probe will be placed on the ventral wrist parallel to the long axis of the forearm without undue pressure on the artery during the PWD measurements. The volume gate will be positioned in the center of the arterial lumen, and the size of the gate will be 1/3 lumen of the artery. The angle of insonation is adjusted and maintained at 50-60 degrees. Once a desired PWD spectral waveform is achieved, the arterial hemodynamic parameters will be recorded.

Phase 2 The subjects of study are patients undergoing upper extremity operation under supraclavicular brachial plexus block. All patients will be randomly assigned to receive 30ml ropivacaine in concentrations of 0.125%, 0.2%, 0.25%, 0.375%, 0.5%, or 0.75%. Patients are randomised to the four groups by random number(generated by computer) in sealed envelopes. All nerve blocks were performed by a single dedicated anaesthetist who remains blinded to the concentration of ropivacaine.

A second investigator, who is blinded to the protocol and patient allocation, will perform the measurements. Another investigator, who is not present during the conduct of the BPB and blinded to the concentration of ropivacaine used will assess each blockade. Patient are also blinded.

The brachial plexus will be visualized using a high-frequency linear ultrasound transducer in the supraclavicular fossa. After skin disinfection and infiltrating with 1% lidocaine, nerve stimulation needle will be inserted using in-line technique,and advanced among the divisions of brachial plexus with electric impulses (2 Hz, 0.3mA, 0.1 ms) of nerve stimulator. If visible contraction of the innervated muscle is elicited, the needle will be withdrawn slowly until the corresponding muscle contraction disappears to avoid intrafascicular puncture. The local anesthetic will be injected at three locations: adjacent to the superficial divisions of the plexus, adjacent to the middle divisions and inferior divisions. The proportion of the volume injected in each area is at the discretion of the expert operator according to the spread of local anesthetic.

The efficacy of the block will be assessed by pinprick sensation (22 G needle) and compared with the opposite arm/hand for normal, hypoesthesia or no sensation. For patients with an ineffective block, supplementary local anesthesia will be administered according to the distribution of the block and site of surgery after measurement. If the patient experienced any pain during surgery, supplementary analgesia, sedation, or general anesthesia will be administered as required.

Patient's arm is in supination. The brachial artery will be located in 2 cm proximal to the antecubital fossa. Hemodynamic Parameters will be measured by Pulsed-wave Doppler(PWD) ultrasound. The probe will be parallel the long axis of the arm without undue pressure on the artery during the PWD measurements. The volume gate will be positioned in the center of the arterial lumen, and the size of the gate will be 1/3 lumen of the artery. The angle of insonation will be adjusted and maintained at 50-60 degrees. Once a desired PWD spectral waveform is achieved, the arterial hemodynamic parameters will be recorded. The cross-sectional area (CSA) of the artery will be assessed with B-mode imaging. Probe should be as perpendicular as possible to the long axis of the artery to obtain as round an arterial section as possible. The image at end diastole will be chosen and measured with the cine loop.

Conditions

Upper Limb Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

group MC(phase 1)

specific nerve block:musculocutaneous nerve block

Group Type: OTHER

specific nerve block

Intervention Type: PROCEDURE

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

group UL( phase 1)

specific nerve block:ulnar nerve block

Group Type: OTHER

specific nerve block

Intervention Type: PROCEDURE

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

group RA (phase 1)

specific nerve block:radial nerve block

Group Type: OTHER

specific nerve block

Intervention Type: PROCEDURE

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

group ME (phase 1)

specific nerve block:median nerve block

Group Type: OTHER

specific nerve block

Intervention Type: PROCEDURE

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

group A(phase 2)

30ml ropivacaine 0.125%

Group Type: EXPERIMENTAL

ropivacaine

Intervention Type: DRUG

Different concentration of ropivacaine

group B(phase 2)

30ml ropivacaine 0.2%

Group Type: EXPERIMENTAL

ropivacaine

Intervention Type: DRUG

Different concentration of ropivacaine

group C(phase 2)

30ml ropivacaine 0.25%

Group Type: EXPERIMENTAL

ropivacaine

Intervention Type: DRUG

Different concentration of ropivacaine

group D(phase 2)

30ml ropivacaine 0.375%

Group Type: EXPERIMENTAL

ropivacaine

Intervention Type: DRUG

Different concentration of ropivacaine

group E(phase 2)

30ml ropivacaine 0.5%

Group Type: EXPERIMENTAL

ropivacaine

Intervention Type: DRUG

Different concentration of ropivacaine

group F(phase 2)

30ml ropivacaine 0.75%

Group Type: EXPERIMENTAL

ropivacaine

Intervention Type: DRUG

Different concentration of ropivacaine

Interventions

specific nerve block

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

Intervention Type: PROCEDURE

ropivacaine

Different concentration of ropivacaine

Intervention Type: DRUG

Other Intervention Names

Naropin

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health and Family Planning Commission of Zhejiang Province, China

UNKNOWN

Sponsor Role: collaborator

Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ting Li

associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ting Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wenzhou Medical University

Locations

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

Wenzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 22030722 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16785004 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18035293 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21367563 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16849019 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15283829 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8594960 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22915862 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7637621 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7598395 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21474476 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10981571 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6875230 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8226291 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15613878 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6884859 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20460999 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17478453 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20167584 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29197338 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26986777 (View on PubMed)

Related Links

http://www.wzhealth.com/content/32.aspx

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

Other Identifiers

2009A145-1

Identifier Type: -

Identifier Source: org_study_id