Analgesia in Pediatric Hypospadias Surgeries
Comparison Between the Analgesic Efficacy of the Ultrasound Penile Block Versus Ultrasound Caudal Epidural for Pediatric Hypospadias Surgeries: A Prospective Randomized Double Blinded Trial
1 other identifier
interventional
26
0 countries
N/A
Brief Summary
The primary aim of the current study will be to use the duration until the first postoperative analgesic requirement after two different block techniques to compare the analgesic effect. The secondary aims will be to compare the two methods for postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scores, complications and parental satisfaction scores.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2023
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedFirst Posted
Study publicly available on registry
May 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedMay 13, 2024
May 1, 2024
1 year
November 14, 2023
May 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative pain and analgesic requirement after two different block techniques to compare the analgesic effect.
Postoperative pain will be assessed using the Children's Hospital Eastern Ontario Pain Scale (CHEOPS) score at 30 minutes, 1, 2, 6, 12 and 24 hours. the minimum score is 4 (better outcome) and the maximum score is 13 (worse outcome). A score ≥ 5 should be considered sufficient to administer an analgesic to the child, where a score of ≥ 8 makes it a requirement to administer an analgesic to the child.
24 hours after the end of surgery
Secondary Outcomes (2)
Postoperative complications
24 hours after the end of surgery
Postoperative Parental satisfaction
24 hours post-operatively
Study Arms (2)
US guided caudal block Anesthesia
EXPERIMENTALChildren will receive caudal block analgesia
Dorsal penile nerve block Anesthesia
ACTIVE COMPARATORChildren will receive Penile block analgesia
Interventions
After placing the patient in the left lateral position (hips and knees flexed) following monitoring and induction of anaesthesia, the field will be sterilized with 70% alcohol in 2% chlorhexidine. Initial scanning in the transverse plane allows for visualization of the midline and identification of the sacrococcygeal ligament between the 2 sacral cornua. The 2 cornua resemble the 2 eyes of a frog and thus are collectively called the frog-eye sign. The US probe is then rotated 90 degrees to acquire a longitudinal view. The needle is then advanced at a 20-degree angle with needle tip and length visualization Once the needle is confirmed to be in the caudal space on the screen, carefully aspirate to confirm absence of CSF or blood. A slow injection of the local anaesthetic can then be performed, dose of (0.2 mL/kg 0.25% bupivacaine and 1 μg/kg of dexmedetomidine
after general anesthesia induction. With the patient in the supine position. After skin sterilization the US linear probe will be transversely placed on the root of the penis. After placing the penis in gentle traction, a50 mm block needle will be inserted from the lateral part of the penis root towards the dorsal section of the penis with the in-plane technique, It will be advanced through Dartos fascia until resistance to the needle disappeared. Once the superficial sheath will be passed, the tip of the needle will be advanced into Buck's fascia and then positioned between Buck's fascia and tunica albuginea, lateral to the dorsal artery. After making sure there will be no blood with negative aspiration, half of the total 0.2 mL/kg dose of 0.25% bupivacaine will be administered while observing its distribution with US. The same procedure will be then repeated on the other side of the penis.
Eligibility Criteria
You may qualify if:
- Children aged 1-7 years old
- ASA I and II
- Children scheduled for primary hypospadias repair
You may not qualify if:
- Patient's guardian refusal to participate in the study.
- Children with Behavioural changes; physical or developmental delay; neurological disorder or psychological disorder.
- Children on sedative or anticonvulsant medication.
- Bleeding diathesis
- Infection of injecting area
- significant organ dysfunction, cardiac, liver or mental retardation.
- Congenital low back anomaly.
- Known allergy to the study drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Kendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447.
PMID: 27501015BACKGROUNDYigit D, Ozen V, Kandirici A, Dokucu AI. Ultrasound-guided dorsal penile nerve block is a safe block in hypospadias surgery: A retrospective clinical study. Medicine (Baltimore). 2022 Jul 1;101(26):e29700. doi: 10.1097/MD.0000000000029700.
PMID: 35777019BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident Doctor
Study Record Dates
First Submitted
November 14, 2023
First Posted
May 13, 2024
Study Start
May 1, 2024
Primary Completion
May 1, 2025
Study Completion
June 1, 2025
Last Updated
May 13, 2024
Record last verified: 2024-05