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

Not Applicable

Completed

• Conditions: Analgesia, Epidural
• Interventions: Drug: ultrasonography-guided TAP block; Drug: Caudal epidural block

• Registration Number: NCT03482947
• Lead Sponsor: 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 .

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

Study Timeline

• Study First Submitted: 2018-03-18
• Study First Submitted QC: 2018-03-28
• Study First Posted: 2018-03-29
• Study Start: 2018-04-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-10-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• patients 2-8 years

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP	ultrasonography-guided TAP block	ultrasonography-guided transversus abdominis plane block administration of (1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine).
Caudal	Caudal epidural block	Caudal epidural block administration of (1 mL/kg of bupivacaine 0.25% \&1 μ/kg dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Postoperative analgesia.	24 hours	time for first analgesic request

Secondary Outcome Measures

Name	Time	Method
Postoperative analgesia	24 hours	total amount analgesic administered
Postoperative pain	24 hours	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).

Trial Locations

Locations (1)

Assiut governorate; 🇪🇬 Assiut, Egypt