triamcinolone: Triamcinolone Versus Methylprednisolone in Transversus Abdominis Plane Block

Sponsor

ghada fouad (Other)

Overall Status

Completed

CT.gov ID

NCT04480775

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Major Abdominal Surgery	Drug: Triamcinolone Drug: Methylprednisolone Drug: bupivacaine	Phase 2/Phase 3

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

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Investigator)

Masking Description:

double blinded

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 15, 2020

Actual Primary Completion Date :

Dec 15, 2020

Actual Study Completion Date :

Dec 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
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 transversus abdominis plane block with bupivacaine alone
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 transversus abdominis plane block with bupivacain and triamicinolone Drug: bupivacaine transversus abdominis plane block with bupivacaine alone
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 transversus abdominis plane block with bupivacaine and methylprednisolone Drug: bupivacaine transversus abdominis plane block with bupivacaine alone

Arm

Intervention/Treatment

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

transversus abdominis plane block with bupivacaine alone

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

transversus abdominis plane block with bupivacain and triamicinolone

Drug: bupivacaine

transversus abdominis plane block with bupivacaine alone

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

transversus abdominis plane block with bupivacaine and methylprednisolone

Drug: bupivacaine

transversus abdominis plane block with bupivacaine alone

Outcome Measures

Primary Outcome Measures

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