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临床试验/NCT05727098
NCT05727098已完成2 期

Comparative Study Between Dexmedetomedine and Ketamine in Erector Spinae Plane Block for Postoperative Analgesia Following Modified Radical Mastectomy. A Prospective Randomized Controlled Study.

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Time to first rescue analgesia request postoperative

研究概览

简要总结

Persistent pain after breast cancer surgery is frequently observed in more than 60% of patients.The suboptimal management of perioperative pain can lead to the occurrence of persistent breast cancer pain syndrome and phantom breast pain. Dexmedetomidine, a novel α2-agonist with an eight-fold affinity for α2-adrenergic receptors (sedate and analgesic effects) as clonidine, while exerts much less α1-effects., has been found to significantly increase the duration of peripheral nerve blocks, with minimal systemic side effects.

Ketamine is a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptors. It is used for sedation, premedication, induction, and maintenance of general anesthesia. Central, regional, and local anesthetic and analgesic properties have been reported for ketamine. Both can be used through Erector spinae plane block for postoperative pain control.

详细描述

Persistent pain after breast cancer surgery is frequently observed in more than 60% of patients.The suboptimal management of perioperative pain can lead to the occurrence of persistent breast cancer pain syndrome and phantom breast pain.

A systematic review and meta-analysis of experimental studies showed that the provision of effective analgesia reduces both the number and incidence of metastases in experimental cancer models . Pain may influence body homeostasis and cancer progression by pain-related immune suppression.

General anesthesia is the conventional, most frequently used anesthetic technique in breast cancer surgical interventions. Various regional anesthetic techniques have also been used; these include local wound infiltration, thoracic epidural anesthesia, paravertebral block (PVB), thoracic spinal anesthesia, and more recently, ultrasound-guided interfacial plane blocks such as pectoral nerve (PECS) blocks type 1 and 2 and the serratus plane block (SPB). Recently introduced erector spinae plane block (ESPB) requires less technical expertise (easy), and may be a safe alternative to PVB. ESP block is described for treating thoracic neuropathic pain with encouraging results. ESP is a potential space deep to erector spinae muscle (ES), where the injected local anaesthetic (LA) spreads cranio-caudally up to several levels as the ES fascia extends from nuchal fascia cranially to the sacrum caudally (C7-T2 cranially and L2-L3 caudally), The block covers somatic and visceral pain during breast surgery blocks by blocking ventral rami, dorsal rami of spinal nerves, and rami communicans that transmit sympathetic fibers.

There is another potentially beneficial effects of regional anaesthesia and analgesia on perioperative outcomes, these include decreased opioids consumption , lower rate of post-operative pulmonary complications, decreased post-operative nausea vomiting (PONV) and decreased duration of post-anaesthesia care unit stay. Regional anaesthesia has long-term oncological outcomes as it is considered protective for cancer recurrence by its indirect and direct antiproliferative effects.

Over recent years, the addition of multiple types of additives to local anesthetics has been reported to improve analgesic effect of peripheral nerve block and regional blocks Dexmedetomidine, a novel α2-agonist with an eight-fold affinity for α2-adrenergic receptors (sedate and analgesic effects) as clonidine, while exerts much less α1-effects., has been found to significantly increase the duration of peripheral nerve blocks, with minimal systemic side effects.

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
Double (Participant, Care Provider)

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

  • ASA I or II .
  • female aged between 18 to
  • Scheduled for elective modified radical mastectomy under general anesthesia.

排除标准

  • Patient known to have allergy to any of the drugs used in the study.
  • Infection at injection site.
  • Coagulation disorders.
  • severe heart ,liver or kidney disease.
  • Unwillingness.

研究组 & 干预措施

Bupivacaine

Active Comparator

Will receive ultrasound guided ESPB with 0,25% Bupivacaine .

干预措施: Bupivacaine Hydrochloride (Drug)

Bupivacaine and dexmedetomedine

Active Comparator

Will receive ultrasound guided ESPB with 0,25% Bupivacaine + Dexmedetomidine.

干预措施: Bupivacaine Hydrochloride and dexmedetomedine (Drug)

Bupivacaine and Ketamine

Active Comparator

will receive ultrasound guided ESPB with 0,25% Bupivacaine + Ketamine.

干预措施: Bupivacaine Hydrochloride and ketamine (Drug)

结局指标

主要结局

Time to first rescue analgesia request postoperative

时间窗: 24 hours

the time of first rescue analgesia

Total opioid consumption

时间窗: 24 hours

Total opioid consumption

次要结局

  • Visual analogue scale.(24 hours)

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

Ehab Hanafy Shaker

Associate Professor of Anesthesia, ICU and Pain management

National Cancer Institute, Egypt

研究点 (1)

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