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临床试验/NCT03954249
NCT03954249已完成不适用

A Randomized Prospective Controlled Study Evaluating the Effectiveness of Bilateral Erector Spinae Plane Blocks in Addition to Standard Multimodal Analgesia at Reducing Opioid Consumption in Patients Undergoing Elective Mammoplasty in an Ambulatory Surgical Center

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2019年11月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
Use of narcotics in first 24 hours

研究概览

简要总结

Study the benefits of a Erector Spinae nerve block for pain control and decrease narcotics usage after mammoplasty in an ambulatory setting

详细描述

Breast surgery is among the most common procedures performed at ambulatory surgery centers. Whether for cosmetic or cancer indications, mastectomy and reduction mammoplasty are being performed under general anesthesia with standard multimodal pharmacologic analgesia. Regional anesthetic techniques have become increasingly prevalent in the management of postoperative analgesia. In oncologic surgery, regional anesthetic techniques have demonstrated a lower incidence of recurrence or metastasis of breast cancer compared to opioid analgesia. The breast has complex innervation, receiving innervation from C5-T7, thus posing a challenge to the regional anesthesiologist.

Current regional techniques for breast and other thoracic surgeries, such as open heart surgery, include the PEC I, PEC II, serratus anterior block as well as the paravertebral block. Of these options, the paravertebral block is heralded as the gold standard for multimodal analgesia in breast surgery. Unfortunately, the paravertebral block carries with it the risk of pneumothorax due to its proximity to the pleura. This risk is also increased when an inexperienced provider is performing the block, which is common on an academic institution. As a result, the PEC I, PEC II and serratus anterior blocks have gained traction, is that they carry less risk of adverse events. One drawback of the PEC blocks and serratus anterior block is that they may not achieve adequate anterior spread and complete coverage of the surgical field, making them less effective at providing adequate post-operative analgesia. Due to these drawbacks, the erector spinae plane block (ESPB) has begun to gain traction as the regional technique of choice for breast surgery. The ESPB is a myofascial block alternative to the paravertebral block. [1] It is performed by injecting local anesthetic in the plane between the erector spinae muscle and the spinal transverse process. The ESPB is thought to be safer than the paravertebral block because the transverse process acts as a barrier to the pleura. It has been postulated that local anesthetic spread reaches the paravertebral space and in fact, cadaveric studies have shown dye spreading to involve the ventral and dorsal rami of spinal nerves. It is because of this mechanism of action that this block has been call the "paravertebral by proxy." The spread of the local anesthetic is volume-dependent, and has been seen to anesthetize between 3-8 vertebral levels when using local anesthetic volumes of 15-20mL. The ESPB has been used successfully for analgesia in open-heart surgery as well as in chronic thoracic neuropathy secondary to herpetic neuralgia. Proponents of the erector spinae block prefer it to the paravertebral block for its ease to perform and seemingly safer profile.

The investigators seek to explore the proposed benefits of the erector spinae plane block in our patients undergoing bilateral breast reduction mammoplasty. Reducing overall opioid use and enhancing recovery after surgery are areas of great importance in the ambulatory, outpatient setting. The investigators hope to show the positive impact of ESPB on both of important perioperative factors.

UPDATE (1/27/2026): The 'actual' Enrollment total has been updated from 76 to 78 on account of an error identified from the time the record was completed in May 2022.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing reduction mammoplasty
  • Age >18 years
  • ASA class I-III

排除标准

  • Patient refusal
  • Renal insufficiency (defined as CKD stage 3 or greater)
  • Infection at the skin at the site of needle puncture
  • Known allergies to any study drugs
  • Coagulopathy
  • Severe asthmatics
  • ASA 4 and 5
  • Pre-existing pain disorder
  • Regular consumption of chronic pain medication
  • Failed block
  • Diagnosis of OSA

研究组 & 干预措施

Erector Spinae nerve block group

Experimental

Receive multimodal analgesia and in addition erector spinae plane block

干预措施: Erecto Spinae nerve block (Procedure)

Multimodal Analgesia group

Active Comparator

Receive standard multimodal analgesia

干预措施: Multimodal Analgesia (Procedure)

结局指标

主要结局

Use of narcotics in first 24 hours

时间窗: 24 hours

The cumulative dose of oral morphine equivalence used in the 24 hours post surgery in morphine equivalents.

次要结局

  • Postoperative nausea and vomiting(Up to 1 day after surgery)
  • Length of stay in PACU(Up to 5 Hours in PACU)
  • Assessment of postoperative pain(Up to 5 Hours in PACU)
  • Patient Satisfaction(Up to 1 day after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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