跳至主要内容
临床试验/NCT03708302
NCT03708302Unknown不适用

Serratus and Parasternal Infrapectoral Block for Breast Surgery. A Randomized Controlled Double Blinded Study to Measure Impact on Time to Hospital Discharge in an Outpatient Setting.

Western University, Canada2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
2
主要终点
Time to hospital discharge.

研究概览

简要总结

Effective pain control is important following breast surgery as it improves quality of recovery, decreases the risk of chronic pain development and reduction of overall health care cost. Current strategies of pain management for breast surgery include use of opioid medication or addition of regional anesthesia along with general anesthesia. Serratus block and parasternal infrapectoral blocks are newly developed fascial plane blocks that are technically easy to perform, effective and safe based on our daily clinical practice and published evidence. We are comparing the addition of serratus and parasternal infrapectoral nerve block with general anesthesia to a combination of placebo and general anesthesia for breast reduction surgery. We propose that this would result in an improved efficiency resulting in early hospital discharge and improve quality of patient care, following breast reduction surgery.

详细描述

Study Introduction:

Severe acute postoperative pain affects nearly 60% of breast surgery patients, potentially triggering adverse physiological and psychological responses, increased chronic pain incidence, and elevated healthcare costs. Effective perioperative pain management reduces chronic pain occurrence, improves recovery quality, and enables early hospital discharge, thus reducing overall healthcare expenses. Various analgesic strategies exist, ranging from regional techniques to opioid-based approaches. Combining multimodal analgesia with regional anesthesia offers superior pain control and enhances recovery quality. The chest wall and breast skin receive innervation from intercostal nerves, with branches providing sensory input to different areas. Understanding this innervation pattern is crucial for optimizing analgesic approaches in breast surgery and ensuring comprehensive pain relief across all affected regions.

Regional analgesic techniques offer several advantages over traditional parenteral opioid therapy, including enhanced pain relief, reduced opioid consumption and related side effects, quicker PACU discharge, and lower chronic pain occurrence. Paravertebral analgesia is particularly effective for breast surgery but presents drawbacks that limit its popularity, such as variable sensory distribution, potential epidural spread, failure rates, and serious risks like total spinal anesthesia or pneumothorax. Interfascial block techniques, aided by ultrasound, have gained traction in regional anesthesia. These techniques involve injecting local anesthetic into neuro-fascial planes adjacent to muscles or between muscle layers, facilitating its distribution to nerves. Interfascial blocks offer advantages like ease of performance, increased safety by avoiding direct nerve targeting, fewer injections, and superficial application, reducing risks associated with deeper nerve blocks. Given these benefits and a thorough understanding of thoracic wall anatomy, several interfascial blocks have been developed as alternatives to paravertebral blocks, aiming for equal efficacy with fewer risks, particularly important in the context of day case breast surgeries.

The serratus block for breast surgery:

The Serratus Plane Block, introduced by Blanco in 2013, involves injecting local anesthetic beneath the serratus anterior muscle to target intercostal nerve branches. However, our recent anatomical study revealed that a single midaxillary line injection inadequately covers the entire breast, prompting additional parasternal injections for comprehensive sensory coverage. Despite this refinement, no randomized controlled trial has yet assessed the efficacy of combined serratus and parasternal infrapectoral blocks in breast surgery analgesia.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women aged 18-80 years
  • ASA I to III (American Society of Anesthesiologists Physical Status Classification System)
  • Undergoing unilateral oncoplastic breast reduction mammoplasty, simple mastectomy surgery, or lumpectomy at St. Joseph's Hospital.
  • Day surgery procedures

排除标准

  • Inability to understand or to provide consent
  • Inability or unwillingness to comply with required follow-up assessments
  • Psychiatric disorder affecting patient assessment
  • Contraindication to regional anesthesia, e.g. coagulopathy
  • Allergy to local anesthetic
  • Chronic pain and/or chronic use of opioids with a daily use of over 30 mg oxycodone or equivalent per day
  • Contraindication to a component of multimodal analgesia
  • Preexisting neuropathy with motor or sensory deficits in the area of the anterolateral chest wall
  • Infection near injection site
  • Pregnancy
  • Complication or adverse events unrelated to the study intervention that precludes evaluation of the primary and secondary outcomes.

研究组 & 干预措施

Study Group

Active Comparator

Ultrasound guided unilateral serratus plane block and unilateral parasternal infrapectoral block with 0.5% ropivacaine.

干预措施: Unilateral serratus plane block (Procedure)

Study Group

Active Comparator

Ultrasound guided unilateral serratus plane block and unilateral parasternal infrapectoral block with 0.5% ropivacaine.

干预措施: Unilateral parasternal infrapectoral block (Procedure)

Control Group

Sham Comparator

Ultrasound guided unilateral serratus plane block and unilateral parasternal infrapectoral block with 0.9% saline.

干预措施: Unilateral parasternal infrapectoral block (Procedure)

Control Group

Sham Comparator

Ultrasound guided unilateral serratus plane block and unilateral parasternal infrapectoral block with 0.9% saline.

干预措施: Unilateral serratus plane block (Procedure)

结局指标

主要结局

Time to hospital discharge.

时间窗: 24 hours postoperative period

Comparing time to hospital discharge; the total time being 'admission to postoperative Care Unit after surgery till discharge home.' this will be measured in minutes

次要结局

  • post operative pain score(48 hours)
  • Cumulative Opioid consumption (in Intravenous Morphine equivalent).(48 hours)
  • Duration of Hospital stay in minutes.(24 hours)
  • Opioid-related side effects requiring treatment.(48 hours)
  • Quality of recovery score (QoR) after anesthesia (at discharge and on Post Operative Day 1)(48 hours)
  • Presence/absence of block-related side effects.(48 hours)

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Sponsor

研究点 (2)

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