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CompletedNCT04480775triamcinoloneUpdated Mar 3, 2021

Triamcinolone Versus Methylprednisolone in Transversus Abdominis Plane Block

A Phase 2/3 interventional study of Triamcinolone and Methylprednisolone in Major Abdominal Surgery, sponsored by ghada fouad. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-03-03.

Sponsored by ghada fouad · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

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 .

Read the detailed description

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

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Conditions studied

  • Major Abdominal Surgery

Keywords

  • triamicinolone
  • methylprednisolone
  • transversus abdominisus plane block
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In context

Lead sponsor

ghada fouad is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    bupivacaine group

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

    Drug: bupivacaine

  • Active comparator
    triamicinolone group

    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

    Drug: Triamcinolone · Drug: bupivacaine

  • Active comparator
    methylprednisolone group

    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.

    Drug: Methylprednisolone · Drug: bupivacaine

Interventions

  • transversus abdominis plane block with bupivacain and triamicinolone

  • transversus abdominis plane block with bupivacaine and methylprednisolone

  • transversus abdominis plane block with bupivacaine alone

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What researchers measure

Primary outcomes

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

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

    Time frame: 24 hours after surgery

Secondary outcomes

  1. occurance of complication

    nausea vomiting hemodynamic changes

    Time frame: 24 hours after surgery

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Study locations

1 site
  • Mansoura University
    Al Mansurah, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04480775
Lead sponsor
ghada fouad
Responsible party
ghada fouad (associate professor, Mansoura University) — Sponsor-investigator
First posted
Jul 21, 2020
Start date
Jul 15, 2020
Primary completion
Dec 15, 2020
Completion
Dec 15, 2020
Last update
Mar 3, 2021

Study contacts

marwa M elegemazy, master
principal investigator · Mansoura University
ghada f amer, M.D
study director · associate professor of anesthesia
Eiad a ramzy, M.D
study chair · associate professor of anesthesia
abdelaziz a motaweaa, M.D
study chair · professor of anesthesia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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