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NCT04480775 Clinical Trial

Triamcinolone Versus Methylprednisolone in Transversus Abdominis Plane Block

Major Abdominal Surgery Clinical Trial

— triamcinolone  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04480775
Other study ID # (MS.20.01.999-2020/01/10)
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date July 15, 2020
Est. completion date December 15, 2020

Study information
Verified date March 2021
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .

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

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date December 15, 2020
Est. primary completion date December 15, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Triamcinolone
transversus abdominis plane block with bupivacain and triamicinolone
• Methylprednisolone
transversus abdominis plane block with bupivacaine and methylprednisolone
• bupivacaine
transversus abdominis plane block with bupivacaine alone

Locations
Country Name City State
Egypt Mansoura University Mansoura

Sponsors (1)
Lead Sponsor Collaborator
ghada fouad

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 24 hours after surgery
Secondary occurance of complication nausea vomiting hemodynamic changes 24 hours after surgery
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