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临床试验/NCT02139982
NCT02139982已完成1 期

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

Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
110
试验地点
1
主要终点
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)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

group MC(phase 1)

Other

specific nerve block:musculocutaneous nerve block

干预措施: specific nerve block (Procedure)

group UL( phase 1)

Other

specific nerve block:ulnar nerve block

干预措施: specific nerve block (Procedure)

group RA (phase 1)

Other

specific nerve block:radial nerve block

干预措施: specific nerve block (Procedure)

group ME (phase 1)

Other

specific nerve block:median nerve block

干预措施: specific nerve block (Procedure)

group A(phase 2)

Experimental

30ml ropivacaine 0.125%

干预措施: ropivacaine (Drug)

group B(phase 2)

Experimental

30ml ropivacaine 0.2%

干预措施: ropivacaine (Drug)

group C(phase 2)

Experimental

30ml ropivacaine 0.25%

干预措施: ropivacaine (Drug)

group D(phase 2)

Experimental

30ml ropivacaine 0.375%

干预措施: ropivacaine (Drug)

group E(phase 2)

Experimental

30ml ropivacaine 0.5%

干预措施: ropivacaine (Drug)

group F(phase 2)

Experimental

30ml ropivacaine 0.75%

干预措施: ropivacaine (Drug)

结局指标

主要结局

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)

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

  • Changes in Skin Temperature From Baseline to 30min After Brachial Plexus Block(Phase 2)(Baseline,30 min after brachial plexus block)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ting Li

associate chief physician

Wenzhou Medical University

研究点 (1)

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