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Triamcinolone Versus Methylprednisolone in Transversus Abdominis Plane Block (triamcinolone)

G

ghada fouad

Status and phase

Completed
Phase 3
Phase 2

Conditions

Major Abdominal Surgery

Treatments

Drug: Methylprednisolone
Drug: Triamcinolone
Drug: bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT04480775
(MS.20.01.999-2020/01/10)

Details and patient eligibility

About

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 .

Full 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

Enrollment

84 patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

84 participants in 3 patient groups

bupivacaine group
Experimental group
Description:
28 Patients will receive 18 ml of bupivacaine 0.5 % plus 1ml 0.9% saline in TAP block divided equally on both sides
Treatment:
Drug: bupivacaine
triamicinolone group
Active Comparator group
Description:
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
Treatment:
Drug: bupivacaine
Drug: Triamcinolone
methylprednisolone group
Active Comparator group
Description:
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.
Treatment:
Drug: bupivacaine
Drug: Methylprednisolone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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