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临床试验/NCT04480775
NCT04480775已完成2 期

Triamcinolone Versus Methylprednisolone in Ultrasound Guided Transversus Abdominis Plane Block in Major Open Abdominal Surgery

ghada fouad1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2020年7月15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
已完成
发起方
入组人数
84
试验地点
1
主要终点
analgesic effect of Triamcinolone and Methylprednisolone In Ultrasound Guided Transversus Abdominis Plane Block ( Tap Block ).

研究概览

简要总结

In the current Study we will compare between triamcinolone and methylprednisolone as an additive to bupivacaine drug in ultrasound guided TAP block in major open abdominal surgery .

详细描述

Postoperative pain is one of the main causes of respiratory function derangement after abdominal surgery .Transversus abdominis plane (TAP) block is widely used in abdominal surgery for postoperative analgesia The transversus abdominis plane (TAP) block is aperipheral nerve block that involves the injection of alocal anesthetic (LA) in the plane between the internaloblique and transversus abdominis muscle layers, with the aim of anesthetizing the intercostal nerves supplyingthe abdominal wall (from T6 to L1) By blocking intercostal nerves T6 to L1, TAPblock efficiently blocks somatic pain after abdominalwall surgery

. It providesadequate postoperative pain relief following various abdominal surgeries TAP block can reduce pain scores, opioid consumption, and the incidence of opioid-related complications after abdominal surgery.

The duration of the TAP block is limited to theeffect of the administered LAs. Various adjuvantmedications have been added to the LA to prolong theduration of TAP block and magnify its effects .

Perineural injection of steroids is reported to influence postoperative analgesia.

As a synthetic glucocorticoid, triamcinolone acetonide binds to and activates the glucocorticoid receptor to produce anti-inflammatory responses,such as down-regulating pro-inflammatory cytokine expression , preventing prostaglandin and leukotriene synthesis and release of arachidonic acid, and activating anti-inflammatory transcription factors such as lipocortins

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

入排标准

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

入选标准

  • Patients scheduled for major open abdominal surgery
  • American Society Anesthesiologists (ASA) physical status I to II

排除标准

  • Patient refusal.
  • Morbidly obese patients.
  • Patients with uncontrolled diabetes.
  • Severe or uncontrolled renal, hepatic or endocrinal diseases.
  • Pregnancy, post-partum or lactating females
  • Allergy to one of the agents used.
  • Recent (less than six months) use of glucocorticoids for at least two weeks

研究组 & 干预措施

bupivacaine group

Experimental

28 Patients will receive 18 ml of bupivacaine 0.5 % plus 1ml 0.9% saline in TAP block divided equally on both sides

干预措施: bupivacaine (Drug)

triamicinolone group

Active Comparator

28 Patient will receive 18 ml of bupivacaine 0.5 % plus (20 mg of triamcinolone in 1ml 0.9% saline divided equally on both sides in TAP block

干预措施: Triamcinolone (Drug)

triamicinolone group

Active Comparator

28 Patient will receive 18 ml of bupivacaine 0.5 % plus (20 mg of triamcinolone in 1ml 0.9% saline divided equally on both sides in TAP block

干预措施: bupivacaine (Drug)

methylprednisolone group

Active Comparator

28 Patient will receive 18 ml of bupivacaine 0.5 % plus (40 mg of methylprednisolone in 1ml 0.9% saline ) on both sides in TAP block.

干预措施: Methylprednisolone (Drug)

methylprednisolone group

Active Comparator

28 Patient will receive 18 ml of bupivacaine 0.5 % plus (40 mg of methylprednisolone in 1ml 0.9% saline ) on both sides in TAP block.

干预措施: bupivacaine (Drug)

结局指标

主要结局

analgesic effect of Triamcinolone and Methylprednisolone In Ultrasound Guided Transversus Abdominis Plane Block ( Tap Block ).

时间窗: 24 hours after surgery

visual analogue scale for assessement of pain from 0 to 10 is used where 0 is no pain and 10 is maximum pain

次要结局

  • occurance of complication(24 hours after surgery)

研究者

发起方
ghada fouad
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

ghada fouad

associate professor

Mansoura University

研究点 (1)

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