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临床试验/NCT05447949
NCT05447949已完成不适用

Comparison of Dexmedetomidine Versus Dexamethasone as Adjuncts to Levobupivacaine in Ultrasound Guided Erector Spinae Plane Block for Patients Undergoing Modified Radical Mastectomy, Randomized Double-Blinded Comparative Study.

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Total amount of morphine consumed postoperatively for 24 hours.

研究概览

简要总结

The aim of this study is to evaluate the analgesic efficacy and safety of adding dexmedetomidine versus dexamethasone to levobupivacaine in ultrasound guided ESPB for patients undergoing modified radical mastectomy

详细描述

Breast cancer is the most common malignancy among females. Modified Radical Mastectomy (MRM) is one of the main surgical treatments of breast cancer .The most common modality for anesthesia is general anesthesia with or without regional blocks . Nearly 40-60% of patients undergoing breast surgery experience severe acute postoperative pain, with severe pain persisting for 6-12 months in almost 10-30% of patients (Post Mastectomy Pain Syndrome; PMPS) . This pain can be severe enough to cause long-term disabilities and interfere with sleep and performance of daily activities.

Postoperative pain is usually managed by opioids, yet it is usually associated with side effects including; prolonged sedation, increase in the incidence of recurrence, respiratory depression , nausea , vomiting and ileus. In an attempt to reduce these side effects, thoracic epidural analgesia and paravertebral block became the gold standard regional techniques for breast surgery. However, both techniques may be associated with serious complications such as pneumothorax, spinal cord injury, incompatibility with pre-existing anticoagulation or antiplatelet therapy and hemodynamic instability. Multiple different regional techniques have been developed in the last decade for postoperative pain management of MRM including including erector spinae plane block (ESPB) aiming to be effective and associated with less complications when compared to the gold standard techniques .

ESPB is a simple and safe paraspinal fascial plane block that involves injection of local anesthetic deep in the erector spinae muscle and superficial to the tips of the thoracic transverse processes hoping to block both ventral and dorsal rami of spinal nerves in the paravertebral area. However, regional blocks after a single dose of local anesthetic are of limited duration and efficacy. Hence, the co-administration of adjuvants with local anesthetics may be helpful for prolongation and potentiation of the analgesic effect. Dexmedetomidine is a potent α2agonist of which α2/α1 selectivity is 8 times greater than clonidine and is now emerging as an adjunct to regional and general anesthesia. It can prolong the duration of the nerve block when used with a local anesthetic .Dexamethasone is considered as an adjuvant as it act by reducing the release of inflammatory mediators and by inhibiting discharge of C-fibers. There is a limited number of studies covering the effect of dexmedetomidine versus dexamethasone when added to ESPB, yet they are still lacking in breast surgeries. Our study aims at studying the effect of adding dexmedetomidine compared to dexamethasone as adjuncts to ESPB in modified radical mastectomy.

Objectives:

To identify the intraoperative and postoperative opioid consumption, as well as duration of analgesia and study the effect on hemodynamics.

研究设计

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

盲法说明

Both the investigator for postoperative pain and the patients will be blinded

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Type of surgery; Modified Radical Mastectomy (MRM)
  • Physical status ASA II, III.
  • Age ≥ 18 and ≤ 65 Years.
  • Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.

排除标准

  • Patient's refusal
  • Age <18 years or >65 years
  • BMI <20 kg/m2 and >35 kg/m2
  • Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids).
  • History of psychological disorders and/or chronic pain.
  • Contraindication to regional anaesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
  • Severe respiratory or cardiac disorders.
  • Advanced liver or kidney disease. Pregnancy.
  • Physical status ASA IV.

结局指标

主要结局

Total amount of morphine consumed postoperatively for 24 hours.

时间窗: 24 hours

Total amount of morphine consumed postoperatively in mg for 24 hours.

次要结局

  • Time to first rescue analgesia.(24 hours)
  • Change in heart rate intraoperatively(Duration of surgery)
  • Incidence of Postoperative nausea and vomiting (PONV).(24 hours postoperative)
  • Total amount of fentanyl consumed intraoperatively.(Duration of surgery)
  • Change in mean arterial blood pressure intraoperatively(Duration of surgery)
  • Postoperative sedation according to Ramsay scores.(24 hours)
  • Numeric Pain Rating Scale score, both at rest and during movement(24 hours postoperative)
  • Block related complications(24 hours postoperative)
  • Patient's satisfaction(24 hours postoperative)

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Magdy Abdelrahman Elsayed

Assistant Lecturer of Anesthesiology , ICU and Pain Management

National Cancer Institute, Egypt

研究点 (1)

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