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临床试验/NCT05984212
NCT05984212尚未招募不适用

Effect of Preoperative Rectus Sheath Block on Quality of Recovery in Single Port Laparoscopic Adnexal Surgery: A Randomized Controlled Trial

Yonsei University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
56
试验地点
1
主要终点
Quality of Recovery 40 scale score at postoperative 24 hour

研究概览

简要总结

In this study, the investigators aimed to demonstrate if the quality of recovery in patients undergoing single-port laparoscopic adnexal surgery, with preoperative rectus sheath block and intraoperative opioid administration based on analgesia nociception index, improves compared to the patients without block.

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

Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation

入排标准

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

入选标准

  • Adult female patient aged 19 years or older undergoing elective single-port laparoscopic adnexal surgery under general anesthesia at Yonsei Cancer Center
  • patients with moderate to severe pain before surgery
  • patients with history of taking chronic analgesic use,
  • patients allergic or hypersensite to remifentanil or local anesthetic (ropivacaine),
  • patients with infection at the site of the block,
  • patietns who cannot communicate

排除标准

  • 未提供

研究组 & 干预措施

dexmedetomidine infusion group

Experimental

干预措施: Ultrasound guided rectus sheath block with dexmedetomidine (Drug)

normal saline infusion group

Placebo Comparator

干预措施: Ultrasound guided rectus sheath block with normal saline (Drug)

结局指标

主要结局

Quality of Recovery 40 scale score at postoperative 24 hour

时间窗: 24 hours after the end of surgery

Postoperative quality of recovery according to the block performance

次要结局

  • rescue analgesics administered up to 24 hours postoperatively(intraoprative and postoperative 24hours)
  • Intraoperative remifentanil consumption,postoperative pain score(at 0, 1, 6, 12, and 24 hours postoperative)
  • satisfaction with pain control(intraoprative and postoperative 24hours)
  • serum cortisol level (μg/dL) before and after surgery(intraoprative and postoperative 24hours)
  • leukocyte level (10^3/μL) before and after surgery(intraoprative and postoperative 24hours)
  • arterial pH before and after surgery(intraoprative and postoperative 24hours)
  • blood glucose level (mg/dL) before and after surgery(intraoprative and postoperative 24hours)
  • measurement of adequate analgesia (NRS <4) before and after surgery(intraoprative and postoperative 24hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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