Erector Spinae Plane Block: For Pain Control in Patients Undergoing Flank Incision

赞助:

合作者:

信息的提供 (责任方):

Suzanne Merrill，Milton S. Hershey Medical Center

追踪信息

首次提交日期 ^ICMJE

March 28, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 2, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

February 28, 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Pain scores using the Visual Analogue Pain Scale from zero pain to level ten pain[ Time Frame: Aggregate pain scores for average length of hospital stay which is 3 days ]

Data will be collected via the electronic medical record and begin following patient randomization. The Visual Analogue Scale pain scales will be administered and collected on Post Operative Days 1, 2 and 3.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Patient Satisfaction Survey of Pain Control Over Time[ Time Frame: Post Operative Day One, date of discharge and clinic follow up visit 14 days postoperatively. ]
Written questionnaire measuring impact of pain upon patient

描述性信息

简略标题 ^ICMJE

Erector Spinae Plane Block: For Pain Control in Patients Undergoing Flank Incision

正式标题 ^ICMJE

Erector Spinae Plane Block (ESPB): A New Technique for Perioperative Pain Control in Patients Undergoing Surgery Through a Flank Incision.

简要概况

Using a randomized double-blinded study design, the study goal is to evaluate the superiority of Erector Spinae Plane block (ESPB) in the peri-operative pain management of patients undergoing surgery through a flank incision as compared to the standard of care of using IV and oral opiates.

详细说明

40 subjects will be randomized in to 2 groups, with 20 in each group. - Group 1. Erector spinae plane block (ESPB) (containing Ropivacaine) - Group 2. Sham Erector spinae plane block. (SESPB) (with normal saline)

研究类型 ^ICMJE

Interventional

研究阶段

Phase 4

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Ropivacaine
Erector Spinae Block with ropivacaine infusion with standard of care analgesics for perioperative pain control
Drug: Normal saline
Erector Spinae Block with saline infusion with standard of care analgesics for for perioperative pain control

研究工具

Experimental: Ropivicaine
Erector Spinae Block of 20ml 0.5% ropivicaine bolus, connected to a pump containing 0.2% ropivicaine receiving 15ml every 3 hrs.
Sham Comparator: Normal Saline
Erector Spinae Block of 20ml normal saline placebo bolus, then connected to pump of normal saline receiving 15ml every 3 hrs.

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

February 28, 2020

预计主要完成日期

February 28, 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Consenting adults age 18-85 - American Society of Anesthesiologists (ASA) Physical Status classification I to III - Planned to be hospitalized for at least 24 hours post-op - Cognitive capacity to use the visual analogic scale (VAS) and complete the patient satisfaction survey Exclusion Criteria: - Patient refusal - Patients with allergies to local anesthetics or opiates (hydromorphone or oxycodone) - Scoliosis - Patients with chronic pain syndromes or who are on chronic pain medications/other neurologic medication of more than 3 months or whom have neuromodulators/stimulators - Concurrent surgeries requiring additional incisions on the body

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：85 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: Yes
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Suzanne Merrill，Milton S. Hershey Medical Center

研究赞助商 ^ICMJE

Milton S. Hershey Medical Center

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Suzanne B Merrill, M.D. Milton S. Hershey Medical Center
Principal Investigator: Sanjib Adhikary, M.D. Milton S. Hershey Medical Center

PRS 账户

Milton S. Hershey Medical Center

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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