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临床试验/NCT04300153
NCT04300153已完成不适用

The Effect of Erector Spinae Plane Block on Quality of Recovery and Postoperative Analgesia of Patients Undergoing Inguinal Hernia Repair: Randomized, Controlled, Double Blinded Trial

Başak Altıparmak2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2020年3月25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
73
试验地点
2
主要终点
Global Quality of Recovery-15 score

研究概览

简要总结

Inguinal hernia repair (IHR) is one of the most commonly performed operations in general surgery practice. Different pharmacological approaches and interfascial plane blocks are used to control postoperative pain. Erector spinae plane (ESP) block is a relatively new interfascial plane block which was reported to be effective in different types of surgeries. In this study, the primary aim is to assess the effect of ESP on recovery of patients following open IHR surgery.

详细描述

Inguinal hernia repair (IHR) is one of the most commonly performed operations in general surgery practice. Unfortunately, 40% of the patients experience moderate-to-severe acute pain in the early period. Erector spinae plane (ESP) block is a relatively new interfascial plane block which was described in 2016. In this prospective, controlled trial, the primary hypothesis is that ultrasound-guided unilateral ESP block will provide an increase in the quality of recovery-15 scores which will be assessed at the postoperative 24th hour following open IHR surgery. The secondary hypothesis is that ESP block will reduce postoperative pain scores, need for rescue analgesia and time to first mobilization.The study will be conducted as a single-center, prospective, randomized, controlled, double-blinded trial in a university hospital. Patients scheduled for an elective unilateral open IHR under spinal anesthesia, will be screened for enrollment to the study. At the end of the operation, patients will be randomized to receive a unilateral ESP block with 30 ml of 0.25% bupivacaine or 30 ml of normal saline at the level of T12 vertebrae. A blinded anesthesiologist will collect outcome measures in the postoperative period.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status I-II
  • Elective unilateral open inguinal hernia repair under spinal anesthesia

排除标准

  • Coagulation disorder
  • Known allergy to study drugs
  • Chronic opioid use
  • Infection at the injection site
  • Use of pain medications
  • Psychologic disorder or inability to cooperate Quality of Recovery-15 (QoR-15) test
  • Preoperative pain related to inguinal hernia NRS > 4/10

结局指标

主要结局

Global Quality of Recovery-15 score

时间窗: Postoperative 24th hour

Global quality of recovery (QoR) score which will be measured by using 15-item QoR-15 questionnaire. This questionnaire covers a total of 15 questions under five clinical dimensions of health; physical comfort (five-item), emotional status (four-item), psychological support (two-item), physical independence (two-item) and pain (two-item)

次要结局

  • Numeric Rating Scale (NRS)(24 hours)
  • Mobilization time(24 hours)
  • Rescue analgesia(24 hours)

研究者

发起方
Başak Altıparmak
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Başak Altıparmak

Assoc Prof

Muğla Sıtkı Koçman University

研究点 (2)

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