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临床试验/NCT02059070
NCT02059070已完成不适用

The Effect of Continuous Interscalene Brachial Plexus Block With 0.125% Bupivacaine Versus 0.2% Ropivacaine on Diaphragmatic Motility and Ventilatory Function

Anesthesiology WSU/DMC-NorthStar1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
1
主要终点
Forced Expiratory Volume at 1 Second (% Change From Baseline)

研究概览

简要总结

Background: Outpatient continuous interscalene brachial plexus blocks are used to control pain after shoulder surgery, with infusions of 0.125% bupivacaine or 0.2% ropivacaine. There have been no studies comparing the effects of these two formulations. The major concern is hemidiaphragmatic paresis, and since ropivacaine preferentially blocks sensory fibers, it may cause less blockade of the phrenic nerve. This study was to evaluate the effects of continuous interscalene brachial plexus infusions, with the hypothesis that respiratory function is more affected by 0.125% bupivacaine than 0.2% ropivacaine, with equal effects on pain relief.

Methods: All patients underwent baseline spirometry and ultrasound evaluation of diaphragmatic excursion, followed by interscalene catheter placement for their surgery, then randomized to receive a pump containing 0.2% ropivacaine or 0.125% bupivacaine. Patients returned to the hospital the following day for spirometry, ultrasound reevaluation, and evaluation of their pain level since discharge.

详细描述

INTRODUCTION

Shoulder surgery is associated with severe postoperative pain and continuous interscalene brachial plexus blocks can control this pain. Compared to single-shot injections, continuous interscalene blocks can increase patient satisfaction, decrease narcotic requirements, which then decreases postoperative nausea and vomiting , improve quality of sleep and decrease hospital length of stay .

The concept of continuous peripheral nerve blocks at home (CPNBH) with disposable pumps began in 1998 in Sweden. The authors chose 0.125% bupivacaine for interscalene catheters and their choice was not based on any evidence in the literature, but rather "because this concentration was already available at the institution for epidural infusions" (personal communication, Dr. Narinder Rawal, January 2013). Two years later, as ropivacaine became more widely available, others chose to evaluate the safety and efficacy of 0.2% ropivacaine for continuous interscalene infusions. Again, the choice of this specific concentration was not evidence-based, but rather "because the company made it in this concentration" (personal communication, Dr. Stephen Klein, January 2013). To date, published reviews show that most studies use either of those formulations, yet there have been no studies comparing the effects of these two drugs and concentrations, particularly on pain relief and on major side effects of CPNBH.

One of those major side effects is ipsilateral phrenic nerve paresis. This is because blockade of the brachial plexus at the interscalene groove with a single large-volume injection causes diaphragmatic hemiparesis in 100% of patients. This incidence is decreased to 20% with a continuous infusion of a dilute solution11, where 9% of patients have a subjective feeling of shortness of breath. An ideal infusate in CPNBH would control postoperative pain and have minimal effects on the phrenic nerve.

Ropivacaine has been shown to have blockade properties that differ from bupivacaine; specifically, ropivacaine seems to preferentially block sensory nerve fibers, while weakly blocking motor fibers. It is not known whether this translates into a more attenuated block of the phrenic nerve with ropivacaine. Therefore, the purpose of this study was to evaluate the effects of continuous interscalene peripheral nerve blocks with 0.125% bupivacaine versus 0.2% ropivacaine, comparing their effect on pain relief and respiratory function. The primary hypothesis is that respiratory function is more affected by bupivacaine than ropivacaine, with equal effects on pain relief.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, 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

  • Patients undergoing shoulder surgery
  • Patients must be willing to give written informed consent
  • Patients must be able and willing to return to hospital on the first postoperative day for study follow-up procedures
  • Patients must have a working phone number where they can be reached daily after surgery

排除标准

  • Patients who do not receive an interscalene catheter for their respective surgery for any reason
  • Patients that received an interscalene catheter, but had any surgical or catheter adverse events prior to discharge
  • Patients with a history of adverse reactions to either study drug
  • Patients with a history of contralateral phrenic nerve paralysis,
  • Patients with a history of extensive prior lung surgery on either lung.
  • Patients with a history of decreased pulmonary function
  • Any emergent cases

研究组 & 干预措施

0.125% Bupivacaine

Experimental

Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.

干预措施: Bupivacaine (Drug)

0.2% Ropivacaine

Experimental

Group 2) Post-operative 0.2% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Forced Expiratory Volume at 1 Second (% Change From Baseline)

时间窗: Within the first 4 days following surgery

次要结局

  • Ultrasonographic Evaluation of Diaphragmatic Excursion- Operative Side Sigh Test(Within 36hrs following surgery)
  • Post-operative Oxycodone Use (mg)(The 24 hour period following surgery)

研究者

发起方
Anesthesiology WSU/DMC-NorthStar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pranav Patel

Principal investigator

Anesthesiology WSU/DMC-NorthStar

研究点 (1)

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