Analgesia in Pediatric Hypospadias Surgeries
- Conditions
- Hypospadias
- Interventions
- Procedure: Dorsal penile nerve blockProcedure: US guided caudal block
- Registration Number
- NCT06410482
- Lead Sponsor
- Assiut University
- 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.
- Detailed Description
Hypospadias, seen in every 200-300 births, is one of the most common congenital anomalies of the penis and is defined as the urethral meatus being located in the ventral part of the penis instead of its normal place.
Although current guidelines propose an optimal age for hypospadias repair of 6-18 months , patient ages vary widely, from infants to adults, in daily practice. According to the literature, hypospadias surgery can be performed in a wide age range of 6 months-12 years. The age of the patients undergoing hypospadias surgery in our country can vary between 1 and 10 years. The surgery of this anomaly is very painful in the postoperative period and requires long-term analgesia. Regional anesthesia methods combined with general anesthesia play an important role in providing effective and long-term postoperative pain control in pediatric penile surgery. These methods also reduce postoperative morbidity, enable early mobilization and significantly decrease the need for narcotic analgesics.
A dorsal penile nerve block (DPNB) and caudal epidural block (CEB) are commonly used regional anesthesia techniques for postoperative pain control in hypospadias repair. CEB is the more commonly used neuraxial block method for providing effective postoperative analgesia in lower abdominal, urogenital and lower extremity surgical operations in pediatric patients. However, it has recently been suggested in the literature that peripheral nerve blocks should be preferred to neuraxial blocks as they provide longer-term analgesia and have fewer side effects. DPNB is a peripheral nerve block method that has been widely used for various penile operations since it will be first defined in the mid-1970s. This method is mostly used with the landmark technique. It will be first used by Sandeman et al via the out-of-plane technique with ultrasound (US) and will be reported to provide effective analgesia in the postoperative period. Suleman et al described DPNB for the first time with the in-plane technique, indicating that the tissue and neurovascular structures of the penis could be better distinguished in the transverse plane in ultrasound (US). A limited number of studies have shown the technique to provide more effective and longer term postoperative analgesia compared to the landmark technique and CEB.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 26
-
• Children aged 1-7 years old
- ASA I and II
- Children scheduled for primary hypospadias repair
-
• 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dorsal penile nerve block Anesthesia Dorsal penile nerve block Children will receive Penile block analgesia US guided caudal block Anesthesia US guided caudal block Children will receive caudal block analgesia
- Primary Outcome Measures
Name Time Method postoperative pain and analgesic requirement after two different block techniques to compare the analgesic effect. 24 hours after the end of surgery 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.
- Secondary Outcome Measures
Name Time Method Postoperative complications 24 hours after the end of surgery Postoperative complications as nausea, vomiting, urinary retention, lower limb numbness, motor block, and ecchymosis or hematoma at site of injection will be recorded.
Postoperative Parental satisfaction 24 hours post-operatively 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)