Clinical trial NCT04480775: Triamcinolone Versus Methylprednisolone in Transversus Abdominis Plane Block
Official title: Triamcinolone Versus Methylprednisolone in Ultrasound Guided Transversus Abdominis Plane Block in Major Open Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Major Abdominal Surgery
Keywords: triamicinolone
methylprednisolone
transversus abdominisus plane block
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: analgesic effect of Triamcinolone and Methylprednisolone In Ultrasound Guided Transversus Abdominis Plane Block ( Tap Block ).
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: occurance of complication
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
affiliation: Mansoura University
name: marwa M elegemazy, master
role: PRINCIPAL_INVESTIGATOR
affiliation: associate professor of anesthesia
name: ghada f amer, M.D
role: STUDY_DIRECTOR
affiliation: associate professor of anesthesia
name: Eiad a ramzy, M.D
role: STUDY_CHAIR
affiliation: professor of anesthesia
name: abdelaziz a motaweaa, M.D
role: STUDY_CHAIR
References: