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TAP vs Caudal Block Using Dexmedetomidine/ Bupivacaine for Post Operative Analgesia

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: NCT03482947
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Ghada Mohammed AboelFadl, Assiut University

Brief Summary:
Caudal epidural block is a well-established and commonly performed regional neuraxial technique for providing intraoperative and postoperative analgesia in children scheduled for lower abdomen/perineal surgical interventions. Although the efficacy and safety of Caudal epidural block are fairly high, the associated complications, such as inadvertent dural puncture, unwarranted motor blockade of the lower limbs, and disturbance of bladder function, limit its use. Furthermore, a major limitation of an uncomplicated Caudal epidural block when administered as a "single-shot" technique is its brief duration of action (up to 6 hours), which makes administration of additional analgesics necessary .

Condition or disease Intervention/treatment Phase
Analgesia, Epidural Drug: ultrasonography-guided TAP block Drug: Caudal epidural block Not Applicable

Detailed Description:
Ultrasonography guidance, by virtue of real-time visualization of the muscle layers and fascial planes, has significantly facilitated practice of regional nerve blockade for it offers confirmation of the spread of the local anesthetic drug in the correct space. Interestingly, there has been a reinvigoration of interest in ultrasonography-guided transversus abdominis plane block in children since its emergence as a valid postoperative analgesia alternative in adults undergoing abdominal surgery. transversus abdominis plane block involves blockade of spinal afferent nerves in the neurofascial plane between the internal oblique and transversus abdominis muscle. Whereas the advantages (reduction in pain intensity/analgesic requirements) of ultrasonography-guided transversus abdominis plane block have been well documented in adults in the first 48 hours post surgery, in children, its use as a primary postoperative analgesia technique remains limited. Caudal anesthesia is easy to perform in younger children; however, its main disadvantage is the short duration of action. Even bupivacaine, along-acting local anesthetic drug, can provide only4-8 h of analgesia. Dexmedetomidine is a highly selective alfa2 agonist with sedative and analgesic properties. It has an alfa1/2 selectivity ratio of 1600 : 1, which is eight times more potent than clonidine (200 : 1)[16]. DEX has been used effectively in intensive care to aid weaning from mechanical ventilation and is being used increasingly in children

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: TAP vs Caudal Block Using Dexmedetomidine / Bupivacaine Combination for Post Operative Analgesia in Pediatric Patients Undergoing Lower Abdominal Surgeries
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : November 1, 2018


Arm Intervention/treatment
Experimental: TAP
ultrasonography-guided transversus abdominis plane block administration of (0.3 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine).
Drug: ultrasonography-guided TAP block
(0.3 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine).

Experimental: Caudal
Caudal epidural block administration of (1 mL/kg of bupivacaine 0.25% &1 μ/kg dexmedetomidine
Drug: Caudal epidural block
(1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine)




Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 24 hours ]
    using the FLACC scale


Secondary Outcome Measures :
  1. Postoperative analgesia [ Time Frame: 24 hours ]
    total amount analgesic administered



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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients 2-8 years

Exclusion Criteria:


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): NCT03482947


Contacts
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Contact: Ghada Aboelfadl, MD 01005802086 ghadafadl77@gmail.com

Locations
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Egypt
Assiut governorate Recruiting
Assiut, Egypt
Contact: Ghada M Aboelfadl, MD    01005802086    ghadafadl77@gmail.com   
Sponsors and Collaborators
Assiut University

Publications of Results:
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Responsible Party: Ghada Mohammed AboelFadl, MD, Assiut University
ClinicalTrials.gov Identifier: NCT03482947    
Other Study ID Numbers: TAP/ECB
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ghada Mohammed AboelFadl, Assiut University:
Dexmedetomidine
pediatrics; postoperative;
Analgesia; caudal
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dexmedetomidine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action