Upper Limb Nerve BlockPhase 1NCT02139982
The Study of Regional Hemodynamic Changes After Specific Brachial Plexus Block by Ultrasound Guidance
A Phase 1 study testing specific nerve block and ropivacaine in people with Upper Limb Nerve Block, run by Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Upper Limb Nerve Block
- What is being tested?
- specific nerve block and ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist physical status I-III patients
- aged 18-70 yr
- weighing 40-80 kg
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
About this study
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
Read the 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
- Being tested
- specific nerve block, ropivacaine
- Keywords
- hemodynamics, anaesthetics, brachial plexus, peripheral nerves, skin temperature, sympathetic nervous system, dose-response relationship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific nerve blockProcedure or surgery
specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
ropivacaineDrug
Also called Naropin
Different concentration of ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| group MC(phase 1) | Other | specific nerve block:musculocutaneous nerve block Receives: Procedure: specific nerve block |
| group UL( phase 1) | Other | specific nerve block:ulnar nerve block Receives: Procedure: specific nerve block |
| group RA (phase 1) | Other | specific nerve block:radial nerve block Receives: Procedure: specific nerve block |
| group ME (phase 1) | Other | specific nerve block:median nerve block Receives: Procedure: specific nerve block |
| group A(phase 2) | Experimental | 30ml ropivacaine 0.125% Receives: Drug: ropivacaine |
| group B(phase 2) | Experimental | 30ml ropivacaine 0.2% Receives: Drug: ropivacaine |
| group C(phase 2) | Experimental | 30ml ropivacaine 0.25% Receives: Drug: ropivacaine |
| group D(phase 2) | Experimental | 30ml ropivacaine 0.375% Receives: Drug: ropivacaine |
| group E(phase 2) | Experimental | 30ml ropivacaine 0.5% Receives: Drug: ropivacaine |
| group F(phase 2) | Experimental | 30ml ropivacaine 0.75% Receives: Drug: ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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)
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.
Measured: baseline, 30 min after specific nerve block, 30 min after brachial plexus block
Success of Brachial Plexus Block ( Phase 2)
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.
Measured: 30 min after brachial plexus block
Changes in Skin Temperature From Baseline to 30min After Brachial Plexus Block(Phase 2)
Skin temperature was measured at the thenar. change= 30min after brachial plexus block minus baseline
Measured: Baseline,30 min after brachial plexus block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Upper Limb Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Family Planning Commission of Zhejiang Province, China
- Responsible party
- Principal investigator, Ting Li, Wenzhou Medical University
- Investigators
- Ting Li, M.D., Principal investigator, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139982
- Sponsor's protocol ID
- 2009A145-1
- Status last verified
- Jul 2014
- First submitted
- 7 May 2014
- Last updated
- 1 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22030722Shemesh 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.
PubMed 16785004Hermanns 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.
PubMed 18035293Sahin 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.
PubMed 21367563Hingorani 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.
PubMed 16849019Breschan 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.
PubMed 15283829Ebert 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.
PubMed 8594960Badal 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.
PubMed 22915862Van 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.
PubMed 7637621Sonntag 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.
PubMed 7598395Lange 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.
PubMed 21474476Lehtipalo 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.
PubMed 10981571Morgan 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.
PubMed 6875230Campero 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.
PubMed 8226291Kurt 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.
PubMed 15613878
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Regional Hemodynamic Changes After Specific Brachial Plexus Block by Ultrasound Guidance
- ClinicalTrials.gov ID
- NCT02139982
- Acronym / sponsor ID
- 2009A145-1
- Conditions
- Upper Limb Nerve Block
- Keywords
- hemodynamics, anaesthetics, brachial plexus, peripheral nerves, skin temperature, sympathetic nervous system, dose-response relationship
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Health and Family Planning Commission of Zhejiang Province, China
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Posted 24 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| group MC(phase 1) | Other | Procedure: specific nerve blockspecific nerve block:musculocutaneous nerve block |
| group UL( phase 1) | Other | Procedure: specific nerve blockspecific nerve block:ulnar nerve block |
| group RA (phase 1) | Other | Procedure: specific nerve blockspecific nerve block:radial nerve block |
| group ME (phase 1) | Other | Procedure: specific nerve blockspecific nerve block:median nerve block |
| group A(phase 2) | Experimental | Drug: ropivacaine30ml ropivacaine 0.125% |
| group B(phase 2) | Experimental | Drug: ropivacaine30ml ropivacaine 0.2% |
| group C(phase 2) | Experimental | Drug: ropivacaine30ml ropivacaine 0.25% |
| group D(phase 2) | Experimental | Drug: ropivacaine30ml ropivacaine 0.375% |
| group E(phase 2) | Experimental | Drug: ropivacaine30ml ropivacaine 0.5% |
| group F(phase 2) | Experimental | Drug: ropivacaine30ml ropivacaine 0.75% |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologist physical status I-III patients
- aged 18-70 yr
- weighing 40-80 kg
Key exclusion criteria (8 listed)
- infection at the site of needle insertion
- coagulopathy
- international normalized ratio >1.4
- platelet count <80×109 litre-1
- allergy to local anaesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| specific nerve blockspecific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region | Procedure or surgery | group MC(phase 1), group ME (phase 1), group RA (phase 1), group UL( phase 1) |
| ropivacaineAlso: NaropinDifferent concentration of ropivacaine | Drug | group A(phase 2), group B(phase 2), group C(phase 2), group D(phase 2), group E(phase 2), group F(phase 2) |
Primary outcome
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.
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
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.
3 secondary outcomes
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
Success of Brachial Plexus Block ( Phase 2)
Time frame: 30 min after brachial plexus block
Changes in Skin Temperature From Baseline to 30min After Brachial Plexus Block(Phase 2)
Time frame: Baseline,30 min after brachial plexus block
Results and safety
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Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22030722Li 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.
- Background: PubMed 16785004Shemesh 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.
- Background: PubMed 18035293Hermanns 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.
- Background: PubMed 21367563Sahin 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.
- Background: PubMed 16849019Hingorani 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.
- Background: PubMed 15283829Breschan 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.
- Background: PubMed 8594960Ebert 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.
- Background: PubMed 22915862Badal 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.
- Background: PubMed 7637621Van 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.
- Background: PubMed 7598395Sonntag 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.
- Background: PubMed 21474476Lange 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.
- Background: PubMed 10981571Lehtipalo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Li, M.D. principal investigator
Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing specific nerve block and ropivacaine in people with Upper Limb Nerve Block, run by Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02139982, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2014.