跳至主要内容
临床试验/NCT06148168
NCT06148168尚未招募2 期

Comparative Evaluation of Different Doses of Magnesium Sulphate in Oblique Subcostal TAP Block for Laparoscopic Cholecystectomy: a Randomized Double-blind Controlled Study

Assiut University0 个研究点目标入组 72 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
入组人数
72
主要终点
The effect of adding different doses of MgSO4 to bupivacaine via OSCTAB block on postoperative pain according to (NRS) for 24 hours in patients scheduled for LC.

研究概览

简要总结

The aim of this study is to evaluate the effect of adding different doses of MgSO4 to bupivacaine via OSCTAB block on postoperative pain control for 24 hours in patients scheduled for LC.

详细描述

Laparoscopic cholecystectomy (LC) is a gold standard for management of gallbladder stones. Early and easily recovery, less operative morbidities, less postoperative pain, improved cosmetics, less hospitalization days and decreased cost are the superiorities of laparoscopic cholecystectomies over open surgical procedures.

Postoperative pain is the major obstacle for early postoperative ambulation and prolongs the hospital stay. Moreover, it has been hypothesized that intense acute pain after LC may predict development of chronic pain (e.g., post laparoscopic cholecystectomy syndrome). So, aggressive perioperative pain prevention is mandatory.

This pain is routinely managed using opiates, which has several side effects. Transversus abdominis plane (TAP) block is a regional anesthetic technique that has gradually become an alternative for postoperative pain control during laparoscopic abdominal surgeries. It involves the infusion of local anesthetic into the fascial plane of the abdominal wall. Oblique subcostal transversus abdominis plane (OSCTAP) block is an US-guided regional anesthesia technique that anesthetizes the nerves of the lower and upper anterior abdominal wall, specifically from T6 to L1.

Rafi et al and McDonnell et al were the first to describe (OSCTAP) block. They described an anatomical landmark technique and provided evidence of blockade to the mid/lower thoracic and upper lumbar spinal nerves as they travelled in the fascial plane between the transversus abdominis (TA) and internal oblique (IO) muscles.

Evidence supporting the presence of (NMDA) receptors in skin and muscles have led to the use of (MgSO4) which is NMDA antagonist via different routes.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • • Patients programmed for elective LC.
  • American society of anesthesiologists (ASA) physical state I or II.
  • Age over 18 years and less than 60 years old.
  • Patients of both sex are included in the study.

排除标准

  • • Patient refusal.
  • Known hypersensitivity to the study drugs.
  • Body Mass Index > 40 kg/m
  • Inability to accurately describe postoperative pain to investigators.
  • Opioid tolerance or dependence.
  • Preexisting history of chronic pain.
  • History of renal, liver, cardiac, neuropsychiatric disorder problems.
  • Bleeding or coagulation abnormality.

研究组 & 干预措施

Group A

Active Comparator

24 patients will receive OSCTAP block with 25 ml volume on each side (5 ml normal saline plus 20 ml of 0.25 % bupivacaine)

干预措施: Bupivacaine plus normal saline (Drug)

Group B

Active Comparator

24 patients will receive OSCTAP block with 25 ml volume on each side (5 ml normal saline containing 500 mg MgSO4 plus 20 ml of 0.25% bupivacaine)

干预措施: Bupivacaine plus normal saline containing MgSO4 (Drug)

Group C

Active Comparator

24 patients will receive OSCTAP block with 25 ml volume on each side (5 ml normal saline containing 250 mg MgSO4 plus 20 ml of 0.25% bupivacain)

干预措施: Bupivacaine plus normal saline containing MgSO4 (Drug)

结局指标

主要结局

The effect of adding different doses of MgSO4 to bupivacaine via OSCTAB block on postoperative pain according to (NRS) for 24 hours in patients scheduled for LC.

时间窗: 24 hours postoperatively

NRS Score: used to assess pain intensity . It is one of the most commonly used pain scales in medicine. The NRS consists of a numeric version of the visual analog scale. It is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible . This scale can be administered verbally. Rescue analgesia will be nalbuphine 0.1 mg/kg IV when the NRS ≥ 4.

次要结局

未报告次要终点

研究者

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

Mahmoud Yamany Mohamed Kamel

Principle Investigator

Assiut University

相似试验

Magnesium Sulphate in Oblique Subcostal TAP Block | 临床试验