Triamcinolone Versus Methylprednisolone in Transversus Abdominis Plane Block

Phase 2

Completed

• Conditions: Major Abdominal Surgery
• Interventions: Drug: bupivacaine; Drug: Triamcinolone; Drug: Methylprednisolone

• Registration Number: NCT04480775
• Lead Sponsor: ghada fouad

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 .

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 Timeline

• Study First Submitted: 2020-07-13
• Study Start: 2020-07-15
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-21
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine group	bupivacaine	28 Patients will receive 18 ml of bupivacaine 0.5 % plus 1ml 0.9% saline in TAP block divided equally on both sides
triamicinolone group	bupivacaine	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
triamicinolone group	Triamcinolone	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
methylprednisolone group	Methylprednisolone	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.
methylprednisolone group	bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
occurance of complication	24 hours after surgery	nausea vomiting hemodynamic changes

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt