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临床试验/NCT03700177
NCT03700177Unknown4 期

Ropivacaine 0,2% Plus Dexamethasone Versus Ropivacaine 0,2% Plus Placebo in Modified Pectoral Block - a Randomized, Double-blind, Prospective Trial

Medical University Innsbruck1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
60
试验地点
1
主要终点
morphine consumption in the first 72 hours

研究概览

简要总结

To find out if dexamethasone used as adjuvant to ropivacaine, a long-lasting local anesthetic, prolongs the duration of modified pectoral nerve block in women undergoing breast surgery.

详细描述

Breast surgeries are one of the most common forms of surgery conducted in hospitals, and even relatively minor interventions can be associated with significant postoperative pain. The most common surgical procedure for breast cancer is modified radical mastectomy, which means removing a generous amount of skin and the entire breast with axillary evacuation. According to the literature, up to 50% of breast surgery patients experience severe acute postoperative pain, with 10-40% breast cancer patients experiencing pain a year or more after surgery.

Poorly controlled postoperative pain has negative physiological and psychological consequences. Furthermore, effective acute pain control preserves immune function both by suppressing surgical stress response and decreasing the need for general anesthetics and opioids in the perioperative period.

The ultrasound-guided modified, pectoral nerve block is a frequently used, easy, and reliable technique to provide complete analgesia during and after breast surgery. A major limitation to its use for postoperative analgesia is that the analgesic effect lasts only a few hours, after which moderate to severe pain at the surgical site may result in the need for alternative analgesic therapy. Several adjuvants have been used to prolong the analgesic duration of peripheral nerve block, including perineural/interfascial or intravenous dexamethasone.

Our aim is to explore the efficacy of 8 mg dexamethasone added to US-guided modified pectoral nerve block on postoperative pain in patients undergoing major breast surgery.

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 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female gender
  • a American Society of Anesthesiologists (ASA) score of 1 or 2
  • weight: body mass index (BMI) 18 - 35 kg/m2
  • informed consent
  • elective, unilaterale breast surgery

排除标准

  • bleeding disorders
  • any known allergy to the medication
  • diabetes mellitus
  • any disease that leads to alterations in the corticosteroid physiology
  • drug-dependency
  • BMI <18 or > 35
  • systemic infections
  • psychiatric diseases, that are associated with an alteration in the perception of pain
  • tumor spread at the site of injection
  • inflammation at the site of injection
  • pregnancy

研究组 & 干预措施

ropivacaine + placebo

Placebo Comparator

Every participant receives general anesthesia and a modified pectoral nerve block for breast surgery. Participants of this arm receive single-shot ropivacaine (0,2%, 30ml) plus 2ml placebo (NaCl 0,9%).

干预措施: Ropivacaine Injection [Naropin] (Drug)

ropivacaine + dexamethasone

Active Comparator

Every participant receives general anesthesia and a modified pectoral nerve block for breast surgery. Participants of this arm receive single-shot ropivacaine (0,2%, 30ml) plus 2ml dexamethasone (8mg).

干预措施: Dexamethasone (Drug)

ropivacaine + dexamethasone

Active Comparator

Every participant receives general anesthesia and a modified pectoral nerve block for breast surgery. Participants of this arm receive single-shot ropivacaine (0,2%, 30ml) plus 2ml dexamethasone (8mg).

干预措施: Ropivacaine Injection [Naropin] (Drug)

ropivacaine + placebo

Placebo Comparator

Every participant receives general anesthesia and a modified pectoral nerve block for breast surgery. Participants of this arm receive single-shot ropivacaine (0,2%, 30ml) plus 2ml placebo (NaCl 0,9%).

干预措施: Placebo (Drug)

结局指标

主要结局

morphine consumption in the first 72 hours

时间窗: 72 hours

every participants receives a morphine pump (PCA) to exactly measure opioid-consumption

次要结局

  • VAS-scores in the first 72 hours(72 hours)

研究者

发起方
Medical University Innsbruck
申办方类型
Other
责任方
Sponsor

研究点 (1)

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