Triamcinolone Versus Methylprednisolone in Transversus Abdominis Plane Block

NCT04480775 | Completed Phase 2 DMC

• 1 other identifier: (MS.20.01.999-2020/01/10)
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Major Abdominal Surgery

Keywords

triamicinolone; methylprednisolone; transversus abdominisus plane block

Outcome Measures

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

  24 hours after surgery

Secondary Outcomes (1)

• occurance of complication

  24 hours after surgery

Study Arms (3)

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

Drug: bupivacaine

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

Drug: Triamcinolone; Drug: bupivacaine

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.

Drug: Methylprednisolone; Drug: bupivacaine

Interventions

Triamcinolone DRUG

transversus abdominis plane block with bupivacain and triamicinolone

triamicinolone group

Methylprednisolone DRUG

transversus abdominis plane block with bupivacaine and methylprednisolone

methylprednisolone group

bupivacaine DRUG

transversus abdominis plane block with bupivacaine alone

bupivacaine group; methylprednisolone group; triamicinolone group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• ghada fouad: lead

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

Location

MeSH Terms

Interventions

Triamcinolone; Methylprednisolone; Bupivacaine

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Prednisolone; Pregnadienetriols; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• marwa M elegemazy, master

  Mansoura University

  PRINCIPAL INVESTIGATOR

• ghada f amer, M.D

  associate professor of anesthesia

  STUDY DIRECTOR

• Eiad a ramzy, M.D

  associate professor of anesthesia

  STUDY CHAIR

• abdelaziz a motaweaa, M.D

  professor of anesthesia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Model Details: Patient will be evaluated pre operative and full lab will be done In the Pre Anaesthesia Room ,a 20 gauge venous catheter will be inserted in the upper limb , and monitoring included heart rate, electrocardiogram, noninvasiveblood pressure, and peripheral oxygen saturation.Oxygen at the rate of 6 L/min will beadministered through oxygen mask to all patients. The anesthesiologist who performed the block will be blinded to drug solution and not involved in data collection, another anesthesiologist will prepare drug solution and other anesthesiologist collect the data.

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 21, 2020
• Study Start: July 15, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)