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临床试验/NCT05416866
NCT05416866Unknown4 期

Transversus Abdominis Plane Block Plus Quadratus Lumborum Block or Retrolaminar Block of Multiple Injections for Postoperative Analgesia Following Laparoscopic Colorectal Surgery: A Randomized, Double-blind, Controlled Trial

dong zhang0 个研究点目标入组 100 人开始时间: 2022年6月20日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
100
主要终点
the cumulative consumption of sufentanil

研究概览

简要总结

Our hypothesis was that transversus abdominis plane block plus retrolaminar block would reduce postoperative sufentanil consumption and provide superior analgesia compared with transversus abdominis plane block plus quadratus lumborum block for laparoscopic colorectal 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)

盲法说明

Except the regional anesthesiologist who performed the blocks, patients, surgeons, theatre anesthesiologists, ward staff, caregivers, and the outcome assessor were unaware of group allocation. The regional anesthesiologist was not involved in the other parts of the study. All data was collected by personnel blinded to the patient group allocation.

入排标准

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

入选标准

  • American Society of Anesthesiologists (ASA) physical status I-II class
  • Colorectal cancer patients
  • 18 and 80 years old
  • Elective laparoscopic colorectal surgery

排除标准

  • serious complications associated with other systems:
  • severe cardiac insufficiency
  • renal failure
  • hepatic encephalopathy
  • infection in the block injection area
  • coagulopathy
  • a known allergy to local anesthetics
  • a previous history of tranquilizer or opioid abuse,
  • body mass index (BMI) greater than 30 kg/m2 or less than 18 kg/m2,
  • inability to cooperate with the assessment of visual analogue scale (VAS) pain scores
  • refusal to participate in the study

结局指标

主要结局

the cumulative consumption of sufentanil

时间窗: 24 hours after nerves block

the outcome in micrograms

次要结局

  • the patient's mean arterial pressure (MAP), HR at rest and during movement at 1, 2, 4, 6, 8, 12, 18, 24 after nerves block(the time for completion of nerves block was time 0)
  • cumulative sufentanil consumption at predetermined time intervals(within 24 hour after nerves block)
  • time until the earliest single patient-controlled analgesia (PCA) dose of sufentanil(within 24 hour after nerves block)
  • the total dose of rescue analgesia and antiemetic(within 24 hour after nerves block)
  • the number of PCA press(within 24 hour after nerves block)
  • time until the earliest rescue analgesia and antiemetic(within 24 hour after nerves block)
  • block-related complications(within 24 hour after nerves block)
  • other side events(within 24 hour after nerves block)
  • patient satisfaction with pain management(at 24th hour after nerves block)
  • the length of hospital stay(up to 2 weeks)
  • Visual Analog Score (VAS) for pain at rest and during movement at 1, 2, 4, 6, 8, 12, 18, 24 after nerves block(the time for completion of nerves block was time 0)

研究者

发起方
dong zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

dong zhang

Anesthesiologist

Gansu Provincial Hospital

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