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

NCT ID: NCT03482947

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2020-10-01

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

Conditions

Analgesia, Epidural

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

TAP

ultrasonography-guided transversus abdominis plane block administration of (1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine).

Group Type: EXPERIMENTAL

ultrasonography-guided TAP block

Intervention Type: DRUG

(1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine).

Caudal

Caudal epidural block administration of (1 mL/kg of bupivacaine 0.25% \&1 μ/kg dexmedetomidine

Group Type: EXPERIMENTAL

Caudal epidural block

Intervention Type: DRUG

(1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine)

Interventions

ultrasonography-guided TAP block

(1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine).

Intervention Type: DRUG

Caudal epidural block

(1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients 2-8 years

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Mohammed AboelFadl

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut governorate

Asyut, , Egypt

Countries

Egypt

References

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.

Reference Type: RESULT

PMID: 16534352 (View on PubMed)

Koul A, Pant D, Sood J. Caudal clonidine in day-care paediatric surgery. Indian J Anaesth. 2009 Aug;53(4):450-4.

Reference Type: RESULT

PMID: 20640207 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25393589 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19691690 (View on PubMed)

Other Identifiers

TAP/ECB

Identifier Type: -

Identifier Source: org_study_id