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Completed

NCT Number: NCT04480775

Triamcinolone Versus Methylprednisolone in Transversus Abdominis Plane Block

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 .

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mansoura University

Al Mansurah, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Triamcinolone

Drug

transversus abdominis plane block with bupivacain and triamicinolone

methylprednisolone

Drug

transversus abdominis plane block with bupivacaine and methylprednisolone

Bupivacaine

Drug

transversus abdominis plane block with bupivacaine alone

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. occurance of complication

    Time frame: 24 hours after surgery

    nausea vomiting hemodynamic changes

Sponsors and collaborators

Lead sponsor

ghada fouad

Other

Registry information

Official study title

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

Acronym: triamcinolone

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 21, 2020
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.