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Transversus Abdominis Plane Block Versus Erector Spina Plane Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04095325
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
ILKE KUPELI, Erzincan University

Brief Summary:
Regional anesthesia and analgesia techniques are frequently used to provide pain control in pediatric surgical applications. The main advantages of these techniques include ease of application, good analgesic efficacy and low risk of complications (1). It reduces the need for parenteral opioids and increases the quality of postoperative pain control and the satisfaction of the patient and family (2). The aim of this study was to compare the contribution of TAP block and ESP block combined with sedation in pediatric surgery to anesthesia and analgesia during surgery without general anesthesia.

Condition or disease Intervention/treatment Phase
Intraoperative Pain Control Device: Ultrasound guided erector spinae block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Transversus Abdominis Plane Block Versus Erector Spina Plane Block in Pediatric Lower Abdominal Surgery
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 1, 2020

Arm Intervention/treatment
Active Comparator: transversus abdominis plane block
Group 1 (n: 50): those who underwent TAP block after induction of propofol atropine and maintained with only 1 mg / kg / h propofol in anesthesia maintenance
Device: Ultrasound guided erector spinae block
Group 2 (n: 50): those who underwent ESP block after propofol atropine induction and maintained with only 1 mg / kg / h propofol in anesthesia maintenance

Active Comparator: erector spinae block
Group 2 (n: 50): those who underwent ESP block after propofol atropine induction and maintained with only 1 mg / kg / h propofol in anesthesia maintenance
Device: Ultrasound guided erector spinae block
Group 2 (n: 50): those who underwent ESP block after propofol atropine induction and maintained with only 1 mg / kg / h propofol in anesthesia maintenance




Primary Outcome Measures :
  1. Visual analogue scale [ Time Frame: 4 months ]
    effectiveness of erector spinae block on intraoperative anesthesia



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II,
  • undergo elective lower abdominal surgery
  • 2-6 years

Exclusion Criteria:

  • Psychiatric patients,
  • weight> 40 kg,
  • those with cardiac-pulmonary-neurological disease,
  • those with bleeding disorders,
  • infection or wound scarring at the injection site,
  • known allergy to local anesthetics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095325


Contacts
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Contact: ilke küpeli +905555485632 ilkeser2004@gmail.com
Contact: ufuk kuyrukluyıldız drufuk2001@gmail.com

Locations
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Turkey
Erzincan University
Erzincan, Turkey, 24100
Sponsors and Collaborators
Erzincan University

Publications of Results:
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Responsible Party: ILKE KUPELI, assist. prof., Erzincan University
ClinicalTrials.gov Identifier: NCT04095325    
Other Study ID Numbers: EBYU ESP
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atropine
Propofol
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action