Hypospadias Clinical Trial
Official title:
Comparison Between the Analgesic Efficacy of the Ultrasound Penile Block Versus Ultrasound Caudal Epidural for Pediatric Hypospadias Surgeries: A Prospective Randomized Double Blinded Trial
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.
Status | Not yet recruiting |
Enrollment | 26 |
Est. completion date | June 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 1 Year to 7 Years |
Eligibility | Inclusion Criteria: - • Children aged 1-7 years old - ASA I and II - Children scheduled for primary hypospadias repair Exclusion Criteria: - • 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Assiut University |
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. — View Citation
Yigit 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Postoperative complications | Postoperative complications as nausea, vomiting, urinary retention, lower limb numbness, motor block, and ecchymosis or hematoma at site of injection will be recorded. | 24 hours after the end of surgery | |
Secondary | Postoperative Parental satisfaction | Parental satisfaction score will be determined 24 h after the surgery by an anesthetist blinded to the study groups. The child's comfort, activity level and the presence or absence of pain will be used to determine the result as 1 (unsatisfied), 2 (satisfied or good), or 3 (very satisfied or excellent) | 24 hours post-operatively |
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