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临床试验/NCT04839445
NCT04839445已完成不适用

Comparison of Efficacy of Ultrasound-guided Erector Spinae Place Block Versus Transversus Abdominis Plane Block for Intra and Postoperative Pain Control in Total Laparoscopic Hysterectomy: a Randomized Controlled Trial

AUSL Romagna Rimini2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2021年2月22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
78
试验地点
2
主要终点
Postoperative pain control

研究概览

简要总结

The anesthetic techniques for videolaparoscopic surgery include general anesthesia, and locoregional anesthesia in association with general anesthesia in order to reduce or abolish post-operative pain with a simultaneous reduction in the use of opioids and days of hospital stay.

From the studies published so far on videolaparoscopic surgery in general, it is clear that the transversus abdominal plane (TAP) block could have a role in reducing the stretch wall pain secondary to pneumoperitoneum and incisional, although its role in this regard is not yet clear, nor significant statistically results have been produced. The use of erector spinae plane (ESP) block for the management of visceral pain is finding more and more space in the literature, with promising results.

For videolaparoscopic gynecological surgery, the techniques of locoregional anesthesia studied in association with general anesthesia, up to now, include wall blocks, TAP block and ESP block, while neuraxial anesthesia has no indications in this regard.

Although videolaparoscopic hysterectomy is considered less painful than the open-abdomen technique, it requires careful management of post-operative pain. The pain of this surgery is the result of the sum of incisional pain, at the insertion points of the laparoscopic trocars, pain due to pneumoperitoneum usually referred to the shoulder, and visceral pain purely dependent on surgical maneuvers. There is currently no strong evidence to support the use of locoregional anesthesia techniques in videolaparoscopic gynecological surgery. Few studies have been produced about this topic, and they are mostly case series or randomized controlled trials that take into consideration only one technique among those possible. To date, no study compares the various techniques to evaluate the possible superiority of one over the other.

In our hospital anesthesists carry out, in normal clinical practice, all the aforementioned local anesthesia techniques.

The purpose of our work is to evaluate, with a randomized non-sponsored study, the efficacy of the ESP block and the TAP block for intra and post-operative pain control in videolaparoscopic hysterectomy, and to compare the two techniques.

Based on the evidence available in the literature, the two techniques are already part of the current clinical practice of the Anesthesia Unit of our hospital and the choice of one technique over the other is based on anesthetist clinical evaluation to date. The anesthetists involved in the study are adequately trained on both anesthetic procedures.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • American society of anesthesiologists (ASA) I-III risk
  • no contraindication to the execution of the peripheral nerve block
  • signature of the informed consent
  • total videolaparoscopic surgery (no conversion to open-abdomen)

排除标准

  • allergies and / or contraindications to the administration of the drugs used in the study
  • infections and injuries at the puncture site
  • history of opioid abuse or use of opioids in chronic therapy

结局指标

主要结局

Postoperative pain control

时间窗: 12 hours

Evaluate the difference between the two groups regarding post-operative pain using Numeric Rating Scale (NRS) 0= better outcome; 10=worse outcome Score will be measured on the numeric rating scale (NRS), an NRS ≤ 4 will be considered as effective antalgic coverage.

次要结局

  • Intra operative use of opioids.(Surgery time.)
  • Post operative use of non-steroidal anti-inflammatory drugs(2-6-12-24-36 postoperative hours)
  • Days of hospital stay(3 days)
  • Assessment of patient satisfaction with the anesthesiological technique(36 hours)
  • Post operative use of opioids(2-6-12-24-36 postoperative hours)
  • Postoperative nausea and / or vomiting(2-6-12-24-36 postoperative hours)

研究者

发起方
AUSL Romagna Rimini
申办方类型
Other
责任方
Sponsor

研究点 (2)

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