TAP vs Caudal Block Using Dexmedetomidine/ Bupivacaine for Post Operative Analgesia
Primary Purpose
Analgesia, Epidural
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasonography-guided TAP block
Caudal epidural block
Sponsored by
About this trial
This is an interventional prevention trial for Analgesia, Epidural focused on measuring Dexmedetomidine, pediatrics; postoperative;, Analgesia; caudal
Eligibility Criteria
Inclusion Criteria:
- patients 2-8 years
Exclusion Criteria:
Sites / Locations
- Assiut governorate
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TAP
Caudal
Arm Description
ultrasonography-guided transversus abdominis plane block administration of (1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine).
Caudal epidural block administration of (1 mL/kg of bupivacaine 0.25% &1 μ/kg dexmedetomidine
Outcomes
Primary Outcome Measures
Postoperative analgesia.
time for first analgesic request
Secondary Outcome Measures
Postoperative analgesia
total amount analgesic administered
Postoperative pain
using the FLACC scale.Rate child on each of the five categories (face, legs, arms, crying, consolability). Each category is scored on the 0 to 2 scale. Add the scores together (for a total possible score of 0 to 10).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03482947
Brief Title
TAP vs Caudal Block Using Dexmedetomidine/ Bupivacaine for Post Operative Analgesia
Official Title
TAP vs Caudal Block Using Dexmedetomidine/Bupivacaine Combination for Postoperative Analgesia in Pediatric Patients Undergoing Unilateral Inguinal Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 .
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Epidural
Keywords
Dexmedetomidine, pediatrics; postoperative;, Analgesia; caudal
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAP
Arm Type
Experimental
Arm Description
ultrasonography-guided transversus abdominis plane block administration of (1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine).
Arm Title
Caudal
Arm Type
Experimental
Arm Description
Caudal epidural block administration of (1 mL/kg of bupivacaine 0.25% &1 μ/kg dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
ultrasonography-guided TAP block
Intervention Description
(1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine).
Intervention Type
Drug
Intervention Name(s)
Caudal epidural block
Intervention Description
(1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine)
Primary Outcome Measure Information:
Title
Postoperative analgesia.
Description
time for first analgesic request
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Postoperative analgesia
Description
total amount analgesic administered
Time Frame
24 hours
Title
Postoperative pain
Description
using the FLACC scale.Rate child on each of the five categories (face, legs, arms, crying, consolability). Each category is scored on the 0 to 2 scale. Add the scores together (for a total possible score of 0 to 10).
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients 2-8 years
Exclusion Criteria:
Facility Information:
Facility Name
Assiut governorate
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
16534352
Citation
Tsui BC, Berde CB. Caudal analgesia and anesthesia techniques in children. Curr Opin Anaesthesiol. 2005 Jun;18(3):283-8. doi: 10.1097/01.aco.0000169236.91185.5b.
Results Reference
result
PubMed Identifier
20640207
Citation
Koul A, Pant D, Sood J. Caudal clonidine in day-care paediatric surgery. Indian J Anaesth. 2009 Aug;53(4):450-4.
Results Reference
result
PubMed Identifier
25393589
Citation
Suresh S, Long J, Birmingham PK, De Oliveira GS Jr. Are caudal blocks for pain control safe in children? an analysis of 18,650 caudal blocks from the Pediatric Regional Anesthesia Network (PRAN) database. Anesth Analg. 2015 Jan;120(1):151-156. doi: 10.1213/ANE.0000000000000446.
Results Reference
result
PubMed Identifier
19691690
Citation
Menzies R, Congreve K, Herodes V, Berg S, Mason DG. A survey of pediatric caudal extradural anesthesia practice. Paediatr Anaesth. 2009 Sep;19(9):829-36. doi: 10.1111/j.1460-9592.2009.03116.x.
Results Reference
result
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TAP vs Caudal Block Using Dexmedetomidine/ Bupivacaine for Post Operative Analgesia
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