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临床试验/NCT06778707
NCT06778707进行中(未招募)不适用

External Oblique Intercostal Block vs Subcostal Transversus Abdominis Plane Block for Adequate Analgesia in Open Nephrectomy

Tanta University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年1月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
1
主要终点
Total morphine consumption in the first postoperative 24 hour

研究概览

简要总结

The aim of the study is to compare the analgesic efficacy of external oblique intercostal block vs subcostal transversus abdominis plane block in patients undergoing open nephrectomy.

详细描述

This randomized controlled double blinded study will be done on 80 patients (40 in each group), patients will be randomly classified by computer generated numbers. Through a sealed opaque envelope technique, a blinded nurse who will not participate in the study or data collection, will read the number contained in the envelope and make group assignments.

All patients will be seen in the anesthesia clinic, optimization of general condition and all required investigations will be done before surgery. Patients will be premedicated with 1.5 mg midazolam and 4 mg granisetron. Basic monitoring will be applied to the patients such as Pulse oximetry (SPO2), Non-invasive blood pressure (NIBP), Electrocardiogram (ECG), Capnogram and temperature probe.

After adequate preoxygenation, induction of general anesthesia will be done through wide bore cannula using 1 mic/kg fentanyl, 1-2 mg/kg titration of propofol, 0.5mg/kg atracurium. Patients were mechanically ventilated using volume-controlled ventilation (VCV) with adjustment of end tidal carbon dioxide (ETCO2) to be 32-35 mmHg, 50% inspired oxygen in air and sevoflurane concentration to be 1MAC. The patients will receive either block before skin incision that will be done 20 minutes after the block. 0.5 mic/kg fentanyl will be injected when heart rate or blood pressure increases more than 20% of baseline. By the end of the surgery, 1gm paracetamol will be administered with fully reversal of muscle relaxants at the end of the surgery.

Group E This group of patients will receive external oblique intercostal block in supine position. A high-frequency linear transducer will be placed in sagittal plane between the midclavicular and anterior axillary line at the level of the 6 to 8th rib. The pointing mark of the probe will be directed cranially and may be slightly tilted medially for better identification of external oblique muscle and intercostal muscles.

After sterilization of skin and through the in-plane technique directing from cranial to caudal, a needle will be used to pierce the skin, subcutaneous tissue then external oblique muscle to hydrodissect the fascial plane between external oblique muscle and intercostal muscles with 25 ml bupivacaine 0.25 % and 4 mg dexamethasone added to it.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

double blinded prospective

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients who will be included in the study age from 21 to 60 years, both male and female, with American Society of Anesthesiologists (ASA) Physical Status Classification System I-III.

排除标准

  • •Any patient refuses to participate, has bleeding or coagulation disorders, hepatic dysfunction, psychiatric diseases, on chronic opioid use, with history of allergy to local anesthetics and has infection at the needle entry point will be excluded.

研究组 & 干预措施

group E

Active Comparator

This group of patients will receive external oblique intercostal block in supine position. A high-frequency linear transducer will be placed in sagittal plane between the midclavicular and anterior axillary line at the level of the 6 to 8th rib. The pointing mark of the probe will be directed cranially and may be slightly tilted medially for better identification of external oblique muscle and intercostal muscles.

After sterilization of skin and through the in-plane technique directing from cranial to caudal, a needle will be used to pierce the skin, subcutaneous tissue then external oblique muscle to hydrodissect the fascial plane between external oblique muscle and intercostal muscles with 25 ml bupivacaine 0.25 % and 4 mg dexamethasone added to it.

干预措施: External Oblique Intercostal Block (Procedure)

group T

Active Comparator

Subcostal transversus abdominis plane block will be applied to this group and patients will be supine. A high-frequency linear transducer will be placed directly below and along costal margin. After sterilization of skin, with in-plane technique and from lateral to medial, a needle will be used to pierce the skin, subcutaneous tissue then rectus muscle and 25 ml of 0.25 % bupivacaine with 4 mg dexamethasone will be injected between rectus muscle and transversus abdominis muscle.

干预措施: Subcostal Transversus Abdominis Plane Block (Procedure)

结局指标

主要结局

Total morphine consumption in the first postoperative 24 hour

时间窗: first postoperative 24 hour

Total morphine consumption in the first postoperative 24 hour

次要结局

  • NRS when patient reach recovery room and at 2 hour, 6 hour, 12 hour, 18 hour and 24 hour(when patient reach recovery room and at 2 hour, 6 hour, 12 hour, 18 hour and 24 hour)
  • Total intraoperative fentanyl consumption with exclusion of fentanyl used in induction(intraoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Abdel Wahed Ali

Lecturer at anesthesia & surgical ICU & Pain Medicine

Tanta University

研究点 (1)

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