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临床试验/NCT06014749
NCT06014749已完成4 期

ANALGESIC STRATEGIES FOR ABDOMINAL WALL REPAIR: A RANDOMISED NON INFERIORITY TRIAL OF SIPB, EPIDURAL ANALGESIA, AND PORT INFILTRATION

Hospital del Rio Hortega2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
160
试验地点
2
主要终点
postoperative pain management

研究概览

简要总结

Adequate pain control, rehabilitation and early postoperative recovery are currently the model to follow according to the recommended guidelines.In this project the main objective is to evaluate 2 different analgesic strategies, open and laparoscopic surgeries, both intraoperatively and postoperatively, one based on 1. Epidural analgesia and the other 2. Echoguided serratus intercostal block prior to surgical intervention in eventration or abdominal wall repair interventions. or 3 port infiltration and 4 SIPB in laparoscopy We conducted an prospective non inferiority study with a low level of intervention. Epidural analgesia prior to general anesthesia and serratus-intercostal block prior to general anesthesia) following the criteria applied in each case according to the operating room anesthesiologist until reaching the sample size and fulfilling the criteria of: abdominal eventration repair, over 18 years of age, ASA I-III. Signature of the IC. in laparoscopic surgery both techiques are applied after induction of general anaesthesia

详细描述

Adequate pain control, rehabilitation and early postoperative recovery are currently model to follow according to the recommended guidelines.In this project the main objective is to evaluate 2 different analgesic strategies both intraoperatively and postoperatively, one based on 1. Epidural analgesia and the other 2. Echoguided serratus intercostal block prior to surgical intervention in eventration or abdominal wall repair interventions. or 3 port infiltration and 4 SIPB in laparoscopy The investigators conducted an non inferiority study with a low level of intervention. Epidural analgesia , serratus-intercostal block and port infiltration prior to general anesthesia) following the criteria applied in each case according to the operating room anesthesiologist until reaching the sample size and fulfilling the criteria of: abdominal eventration repair, over 18 years of age, ASA I-III. Signature of the IC.

We will assess the analgesia provided by the techniques in both techniques and to compare the results.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • abdominal eventration repair,
  • over 18 years old,
  • ASA I-III.
  • Signature of the IC.

排除标准

  • Allergy to Local anesthetic

研究组 & 干预措施

Patient under serratus intercostal plane block

Active Comparator

patients who will undergo a modified bilateral ultrasound-guided BRILMA block (SIPB) using a high-frequency linear probe (6-15 Hz) and 80 mm needle.

干预措施: undergo (Procedure)

Patient under serratus intercostal plane block

Active Comparator

patients who will undergo a modified bilateral ultrasound-guided BRILMA block (SIPB) using a high-frequency linear probe (6-15 Hz) and 80 mm needle.

干预措施: ultrasound (Device)

Patient under serratus intercostal plane block

Active Comparator

patients who will undergo a modified bilateral ultrasound-guided BRILMA block (SIPB) using a high-frequency linear probe (6-15 Hz) and 80 mm needle.

干预措施: Local anesthetic (Drug)

patient under epidural analgesia

Active Comparator

patients who undergo Epidural Analgesia prior to General Anesthesia and fentanyl 1 mcg/kg approx according to characteristics and needs and upon arrival at the URPA is connected to the PC Levobupi 0.125% at 6 ml / h + rescue boluses of Levobupi 0.125% 4 ml if needed in the 1st hours.

干预措施: undergo (Procedure)

patient under epidural analgesia

Active Comparator

patients who undergo Epidural Analgesia prior to General Anesthesia and fentanyl 1 mcg/kg approx according to characteristics and needs and upon arrival at the URPA is connected to the PC Levobupi 0.125% at 6 ml / h + rescue boluses of Levobupi 0.125% 4 ml if needed in the 1st hours.

干预措施: Local anesthetic (Drug)

结局指标

主要结局

postoperative pain management

时间窗: 24h

Pain control. NRS scale at O,6, 12 and 24 h in postoperative time

postoperative quality of recovery

时间窗: 24h

Quality of recovery, QoR15 scale, that includes physical and psicological item. That scale will be fill by the patient 24 h after surgery

次要结局

未报告次要终点

研究者

发起方
Hospital del Rio Hortega
申办方类型
Other
责任方
Principal Investigator
主要研究者

Judith Andres

MD

Hospital del Rio Hortega

研究点 (2)

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