Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT01194492 - Albumin Kinetics in Generalized Inflammation Phase 4
Completed NCT00512213 - Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery N/A
Completed NCT04798040 - Effects of Lavender Aromatherapy and Cold Application on Pain During Drain Removal N/A
Completed NCT06456918 - ValidationTurkishVersionQualityofRecovery-15
Completed NCT02337010 - Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management N/A
Completed NCT00549419 - Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Abdominal Surgery Phase 4
Completed NCT04080479 - Bolus Versus Continuous Enteral Tube Feeding N/A
Recruiting NCT03295851 - Preoperative Intravenous Iron Infusion to Reduce Post-surgical Complications: a Pilot Randomised Control Trial Phase 4
Withdrawn NCT01403909 - Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery N/A
Recruiting NCT02534012 - Paravertebral Block vs. General Anesthesia for Major Abdominal Surgery N/A
Completed NCT05365113 - Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Major Abdominal Surgery Patients N/A
Recruiting NCT05276596 - Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction N/A
Completed NCT01075646 - Local Anesthesia Versus Saline Serum in Surgical Incision of Colorectal or Hepatic Surgery Phase 4
Completed NCT04935814 - Cardiac Output Response to Vasopressin Infusion In Abdominal Surgery Patients Under Mechanical Ventilation Phase 4
Completed NCT04345354 - Observational Study of the Value of Using Obstructive Sleep Apnea-hypopnea Syndrome (CPAP) Ventilation on the Occurrence of Respiratory and Cardiovascular Complications in Patients at High Risk of Obstructive Apnea Syndrome During Postoperative Sleep Surgery of a Major Abdominal Surgery.
Recruiting NCT06285526 - Glycocalyx Monitoring in Major Abdominal Surgery
Completed NCT03166644 - Individualized Goal-directed Sufentanil Administration Versus Standard Therapy in Patients Undergoing Major Abdominal Surgery N/A
Completed NCT05795608 - Effectivity of Incentive Spirometry on Postoperative Pulmonary Complication After Major Abdominal Surgery N/A
Completed NCT02142816 - Fluid Requirement During Surgery PVI v Doppler N/A
Completed NCT01217151 - Perioperative Hemodynamic Optimization Using the NICOM Device N/A