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临床试验/NCT03059498
NCT03059498已完成早期 1 期

Determining Plasma Bupivacaine Levels Following Pectoral Nerve Blocks: A Prospective Observational Study

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年6月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Peak plasma bupivacaine concentration

研究概览

简要总结

The purpose of this study is to determine peak plasma bupivacaine concentrations in a similar fashion for PECS I/II blocks. The investigators hypothesis is that the mean peak plasma levels for patients undergoing PECS I/II blocks will be less than the levels reported to cause early neurotoxicity of [2.2 (0.9) micrograms/ml]6 in patients receiving intravenous bupivacaine infusions.

详细描述

Regional anesthesia techniques are common modalities used to provide analgesia following both upper and lower extremity surgeries. It is also often used for truncal procedures for the same purpose. A relatively new truncal block, first described in 2012 by Blanco, called the pectoralis nerve block (PECS I and II block) has been used successfully for breast surgery1-3. Despite its description and success in clinical practice, the extent of systemic absorption from this truncal plane block has not been described to date. However, in a study published in the British Journal of Anesthesia, this has been done for another truncal plane block, the transverse abdominus plane (TAP) block where the local anesthetic was noted to peak and had a mean total concentration of ropivacaine occurring at 30 minutes after the block4. During this study, samples were taken at 10, 20, 30, 45, 60, 90, 120, 180, and 240 minutes. The investigators anticipate that since this is a similar truncal plane block, absorption will be comparable in terms of timing. However, the concentration of drug absorbed may be different given the proximity to the ribs, intercostal and thoracic vasculature, and a higher concentration of local given the smaller plane for local anesthetic spread. Given that the investigators want to find the peak of the curve and the peak concentration of bupivacaine from the PECS block, the investigators feel will need 5 samples at the times outlined below. This number of samples was chosen to approximate a study published in 2004 where ten subjects received ropivacaine for scalp blocks and serum ropivacaine levels were measured at 15, 30, 45, 60, 90, and 120 minutes5. The investigators feel that the 120 minute measurement is well beyond the peak plasma level of bupivacaine given the findings in the TAP and scalp studies. Therefore,the investigators will collect the following samples at these times after the block is completed: 5, 10, 20, 40, 60, and 90 minutes. The purpose of this study is to determine peak plasma bupivacaine concentrations in a similar fashion for PECS I/II blocks. The investigators hypothesis is that the mean peak plasma levels for our patients undergoing PECS I/II blocks will be less than the levels reported to cause early neurotoxicity of [2.2 (0.9) micrograms/ml]6 in patients receiving intravenous bupivacaine infusions.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • Patients receiving a unilateral PECS I and II block for any surgery being provided by Wake Forest Baptist Medical Center

排除标准

  • Subjects with contraindications to regional anesthesia, such as a history of allergy to amide local anesthetics,
  • presence of a progressive neurological deficit,
  • a pre-existing coagulopathy,
  • infection at site of injection.
  • or the following conditions:
  • patient receiving any other additional local anesthetic from another procedure
  • infection over site of block
  • patient refusal
  • significant renal or liver dysfunction on laboratory analysis
  • weight <60 kg
  • pregnancy

研究组 & 干预措施

unilateral PECS block patients

Active Comparator

unilateral PECS I and II block using bupivacaine

干预措施: Unilateral PECS I and II block (Procedure)

unilateral PECS block patients

Active Comparator

unilateral PECS I and II block using bupivacaine

干预措施: Bupivacaine (Drug)

bilateral PECS block patients

Active Comparator

bilateral PECS I and II block using bupivacaine

干预措施: Bilateral PECS I and II block (Procedure)

bilateral PECS block patients

Active Comparator

bilateral PECS I and II block using bupivacaine

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Peak plasma bupivacaine concentration

时间窗: 90 minutes after dose

Will be determined by samples collected at these times after the block is completed: 5, 10, 20, 40, 60, and 90 minutes

Bupivacaine mean concentration

时间窗: 90 Minutes after dose

Calculated from samples at these times after the block is completed: 5, 10, 20, 40, 60, and 90 minutes

Standard deviations of plasma bupivacaine concentrations

时间窗: 90 minutes after dose

Will be calculated using samples at these times after the block is completed: 5, 10, 20, 40, 60, and 90 minutes

次要结局

  • Rates of block success(30 minutes after block)
  • Rates of adequate ultrasound success of appropriate separation of the muscular layers for each block.(At the end of the block placement, 0 minutes timepoint.)
  • Rates of symptoms of local anesthetic systemic toxicity(90 minutes after block)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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