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临床试验/NCT06166108
NCT06166108尚未招募2 期

Comparative Evaluation of Magnesium Sulphate Versus Dexamethasone as an Adjuvant to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block for Abdominal Hysterectomy as Postoperative Analgesia

Assiut University0 个研究点目标入组 56 人开始时间: 2023年12月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
尚未招募
入组人数
56
主要终点
Comparasion of postoperative NRS score for 24 hours between the two groups

研究概览

简要总结

The aim of this study is to compare the duration of analgesia obtained by addition of dexamethasone and MgSO4 as adjuvants to bupivacaine in TAP block in patients undergoing Total Abdominal Hysterectomy and to evaluate postoperative analgesic requirements, side effects and level of patient satisfaction.

详细描述

Total abdominal hysterectomy (TAH) is accompanied by an extensive inflammatory response resulting in postoperative discomfort and misery. Such patients require appropriate analgesic treatment to reduce morbidity and complications by blunting autonomic, somatic, and endocrine reflexes. As a result, postoperative analgesia following TAH calls for a multimodal approach.

One of the regional techniques routinely used is the transversus abdominis plane (TAP) block. Its widespread use in abdominal surgeries is due to its technical simplicity and trustworthy analgesia. This block implies administering local anesthetic between the internal oblique muscle and transversus abdominis muscle, which is marked by the lumbar Petit triangle. The primary drawback of single-shot regional blocks is their short duration of action when administered with local anesthetic alone. Several adjuvants, including opioids, alpha 2 agonists, N-methylD-aspartate (NMDA) receptor antagonists, and other drugs, have been utilized to extend the duration of blocks. Opioids are by far the most often used adjuvants, but they accompany a host of unpleasant side effects, such as respiratory depression, drowsiness, nausea, and vomiting. In some studies, using alpha 2 agonists such as Dexmedetomidine and Clonidine has been related to drowsiness and bradycardia.

MgSO4 is an N-methyl-D-aspartate (NMDA) receptor antagonist. It acts by non-competitive antagonism blocking the voltage-dependent ion channels.

Dexamethasone is a highly potent, long-acting glucocorticoid. It inhibits potassium conductance by binding to glucocorticoid receptors which decrease the activity of nociceptive C-fibres and may also prolong the analgesia duration through systemic anti'-inflammatory effects and local vasoconstrictive action.

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
None

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 35-70 years
  • Female patients
  • American society of anesthesiologists (ASA) physical state I-II
  • Undergoing Total Abdominal Hysterectomy

排除标准

  • Patient's refusal
  • Cardio-respiratory conditions
  • Convulsions
  • Local infection at the block's site
  • Bleeding diathesis
  • Known allergy to any drugs used in this study

研究组 & 干预措施

Group M "bupivacaine +normal saline +MgSO4"

Active Comparator

will receive 25 ml volume on each side (20 ml of 0.25% bupivacaine plus 5 ml of normal saline containing 250 mg of MgSO4)

干预措施: transversus abdominis plane (TAP) block in Abdominal hysterectomy (Drug)

Group D "bupivacaine +normal saline +dexamethasone"

Active Comparator

will receive 25ml volume on each side (20 ml of 0.25% bupivacaine plus 5 ml of normal saline containing 8 mg of dexamethasone)

干预措施: transversus abdominis plane (TAP) block in Abdominal hysterectomy (Drug)

结局指标

主要结局

Comparasion of postoperative NRS score for 24 hours between the two groups

时间窗: 24 hours postoperative

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 analogue 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

  • Total amount of rescue analgesic consumption during the first 24 hours postoperatively(24 hours postoperative)
  • Patient satisfaction score(24 hours postoperative)
  • PONV intensity by postoperatively(24 hours postoperative)
  • Postoperative hemodynamic parameters(24 hours postoperative)
  • Time required for the first rescue analgesia(24 hours postoperative)

研究者

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

Ahmed Hamdy Mohamed Saleh

Resident physician at the anesthesiology and intensive care unit at Assuit University Hospitals

Assiut University

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