Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to compare the effectiveness and safety of two regional anesthesia techniques, ultrasound-guided pudendal nerve block and dorsal penile nerve block, for postoperative pain management in children undergoing hypospadias surgery.
The main questions we aim to answer are:
Which technique provides more effective pain relief after surgery? What are the potential side effects or complications associated with each technique?
Participants will:
Receive either an Ultrasound-guided pudendal nerve block or a dorsal penile nerve block in combination with general anesthesia after surgery.
Participants will be monitored for pain levels using a pediatric pain scale Face, Leg, Activity, Cry, Consolability (FLACC) and their overall recovery for the first 24 hours post-surgery.
Have their total analgesic consumption and vital signs recorded during the recovery period.
This study will help improve postoperative pain management strategies for pediatric hypospadias surgery by evaluating these two anesthesia techniques.
This randomized controlled trial aims to evaluate and compare the efficacy of ultrasound-guided pudendal nerve block (USG-PNB) and dorsal penile nerve block (DPNB) for postoperative analgesia in pediatric patients undergoing hypospadias repair surgery. Both techniques are regional anesthesia methods used to manage postoperative pain, but they differ in the sensory regions they target. The study seeks to determine which of these two techniques provides more effective pain relief and assess any associated complications.
A total of 60 pediatric patients, aged 1 to 6 years, undergoing hypospadias surgery under general anesthesia will be enrolled. Patients will be randomly assigned to receive either the USG-PNB or DPNB after induction of anesthesia. The primary outcome of the study is the first postoperative analgesic requirement, measured using the Face, Leg, Activity, Cry, Consolability (FLACC) pain scale. Secondary outcomes include time to first analgesic requirement, postoperative pain intensity at different time points, total analgesic consumption within the first 24 hours, and the monitoring of hemodynamic parameters, including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and complications related to either nerve block technique.
Patients will be monitored in the post-anesthetic care unit for 24 hours, during which pain levels and vital signs will be recorded.
By comparing the two regional anesthesia techniques, this study will contribute to improving postoperative pain management strategies, with a focus on minimizing side effects and improving recovery times in pediatric patients undergoing hypospadias surgery.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-Guided Pudendal Nerve Block Group | Experimental | In this arm, participants will receive ultrasound-guided pudendal nerve block (PNB) for postoperative pain management following hypospadias surgery. The procedure involves the administration of 0.25% bupivacaine (0.2-0.5 mL/kg) mixed with 0.05 mg/kg dexamethasone to block the pudendal nerve. The block will be performed under direct ultrasound visualization after induction of general anesthesia, targeting the perineal area, including both superficial and deeper penile tissues. The effects of this intervention will be compared to the dorsal penile nerve block group in terms of postoperative pain relief and analgesic consumption. |
|
| Ultrasound-Guided Dorsal Penile Nerve Block Group | Active Comparator | Ultrasound-Guided Dorsal Penile Nerve Block Group: In this arm, participants will receive ultrasound-guided dorsal penile nerve block (DPNB) for postoperative pain management following hypospadias surgery. The procedure involves the administration of 0.25% bupivacaine (0.5 mL/kg) mixed with 0.05 mg/kg dexamethasone, targeting the dorsal penile nerve. The block will be performed under direct ultrasound visualization at the penoscrotal junction, focusing on the distal penile region. The effects of this intervention will be compared to the pudendal nerve block group in terms of postoperative pain relief and analgesic consumption |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-Guided Pudendal Nerve Block | Procedure | This intervention involves the use of ultrasound guidance to perform a pudendal nerve block for postoperative pain relief in pediatric patients undergoing hypospadias surgery. The procedure targets the pudendal nerve, which provides sensory innervation to the perineal area, including the genitalia. The block is performed by injecting a mixture of 0.25% bupivacaine and dexamethasone under ultrasound visualization, ensuring precise placement of the needle. This method aims to provide comprehensive analgesia for both superficial and deeper tissues, reducing the need for additional systemic analgesics and improving postoperative recovery. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain intensity by using Face, Leg, Activity, Cry, Consolability (FLACC) scale | The primary outcome measure of this study is the postoperative pain intensity, which will be assessed using the Face, Leg, Activity, Cry, Consolability (FLACC) scale. This scale is designed to evaluate pain in young children who cannot verbally communicate their discomfort. It consists of five categories: Face: The facial expression of the child (e.g., no expression, occasional grimace, or frequent grimace). Legs: The position of the child's legs (e.g., relaxed, tense, or kicking). Activity: The child's level of activity (e.g., lying quietly, squirming, or arching). Cry: The type and frequency of crying (e.g., no cry, occasional complaints, or crying steadily). Consolability: How easily the child can be comforted (e.g., content, reassured by touch, or difficult to console). Each category is scored from 0 to 2, with a total score ranging from 0 to 10. A higher score indicates higher pain intensity. | From the end of surgery to 24 hours post-surgery This includes assessments of postoperative pain intensity using the FLACC scale at various time points, starting immediately after surgery and continuing at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Postoperative Analgesic Requirement | This outcome measures the time interval from the end of surgery to the first request for analgesic medication postoperatively. It is a key indicator of how long the nerve block techniques provide effective pain relief before additional pain medication is required. | From the end of surgery to the first analgesic requirement, within the first 24 hours post-surgery. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AKM Akhtaruzzaman, MD | Bangladesh Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangladesh Medical University | Dhaka | 1000 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20045849 | Background | Voepel-Lewis T, Zanotti J, Dammeyer JA, Merkel S. Reliability and validity of the face, legs, activity, cry, consolability behavioral tool in assessing acute pain in critically ill patients. Am J Crit Care. 2010 Jan;19(1):55-61; quiz 62. doi: 10.4037/ajcc2010624. | |
| 24348179 | Background | Terkawi AS, Karakitsos D, Elbarbary M, Blaivas M, Durieux ME. Ultrasound for the anesthesiologists: present and future. ScientificWorldJournal. 2013 Nov 20;2013:683685. doi: 10.1155/2013/683685. |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| pain.medicine@bsmmu.edu.bd | Study Protocol | View IPD |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ultrasound-Guided Dorsal Penile Nerve Block | Procedure | This intervention involves the use of ultrasound guidance to perform a dorsal penile nerve block for postoperative pain management in pediatric patients undergoing hypospadias surgery. The procedure targets the dorsal penile nerve, which innervates the distal part of the penis. Under ultrasound visualization, a mixture of 0.25% bupivacaine and dexamethasone is injected near the nerve to provide localized analgesia. This block is designed to alleviate pain in the distal penile area but may not offer as broad a sensory coverage as the pudendal nerve block, particularly for deeper tissues. |
|
| Total Postoperative Analgesic Consumption in the First 24 Hours | This outcome measures the total amount of postoperative analgesic medication (including paracetamol, NSAIDs, and any rescue analgesics) consumed by patients during the first 24 hours after surgery. The purpose is to evaluate the effectiveness of the nerve block techniques in reducing the need for additional pain relief. | From the end of surgery to 24 hours post-surgery, with total analgesic consumption recorded at regular intervals. |
| Hear rate (HR) | This outcome measures the heart rate of the patient postoperatively. Monitoring heart rate helps assess the cardiovascular stability of the patient after surgery and anesthesia. | From the end of surgery to 24 hours post-surgery, with heart rate recorded immediately after surgery, and then at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery. |
| Systolic Blood Pressure (SBP) | This outcome measures the systolic blood pressure of the patient postoperatively. It helps evaluate the impact of the nerve block techniques on the patient's blood pressure and circulatory status. | From the end of surgery to 24 hours post-surgery, with systolic blood pressure recorded immediately after surgery, and then at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery. |
| Diastolic Blood Pressure (DBP) | This outcome measures the diastolic blood pressure of the patient postoperatively. It provides additional insight into the patient's cardiovascular status and response to anesthesia and the nerve block techniques | From the end of surgery to 24 hours post-surgery, with diastolic blood pressure recorded immediately after surgery, and then at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery. |
| Mean Arterial Pressure (MAP) | This outcome measures the mean arterial pressure, which is an important indicator of the perfusion pressure and the overall stability of the patient's cardiovascular system after surgery. It reflects the pressure necessary to ensure adequate blood flow to organs and tissues. | From the end of surgery to 24 hours post-surgery, with mean arterial pressure recorded immediately after surgery, and then at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery. |
| Complications related to nerve block | This outcome involves the monitoring and recording of any complications or adverse effects associated with either the ultrasound-guided pudendal nerve block or dorsal penile nerve block. This includes, but is not limited to, issues such as infection, hematoma formation, nerve injury, or systemic reactions to the anesthetics. | From the end of surgery to 24 hours post-surgery, with any complications or adverse events documented during the recovery period. |
| 38729099 | Background | Tao C, Cao Y, Li J. Enhancing pediatric postoperative pain management: strategies, challenges, and innovations - a comprehensive review and observational study. Int J Surg. 2024 Aug 1;110(8):4543-4546. doi: 10.1097/JS9.0000000000001585. No abstract available. |
| 29150457 | Background | Sharara-Chami R, Lakissian Z, Charafeddine L, Milad N, El-Hout Y. Combination Analgesia for Neonatal Circumcision: A Randomized Controlled Trial. Pediatrics. 2017 Dec;140(6):e20171935. doi: 10.1542/peds.2017-1935. Epub 2017 Nov 17. |
| 40200590 | Background | Sridharan H, Kesarkar N, Dias R. Optimizing Paediatric Hypospadias Surgical Repair: Pudendal Nerve Block Versus Caudal Block for Superior Analgesia. Turk J Anaesthesiol Reanim. 2025 May 30;53(3):114-121. doi: 10.4274/TJAR.2025.241773. Epub 2025 Apr 9. |
| 31063627 | Background | Splinter WM, Kim J, Kim AM, Harrison MA. Effect of anesthesia for hypospadias repair on perioperative complications. Paediatr Anaesth. 2019 Jul;29(7):760-767. doi: 10.1111/pan.13657. Epub 2019 May 27. |
| 39583595 | Background | Singh VK, Gupta A, Gupta A, Choudhuri P, Gangwal M. Comparison of the Analgesic Efficacy of Ultrasound-Guided Transperineal Approach Using Pudendal Nerve Block Versus Caudal Block in Children Undergoing Urological Surgeries: A Randomized Controlled Trial. Cureus. 2024 Nov 22;16(11):e74244. doi: 10.7759/cureus.74244. eCollection 2024 Nov. |
| 35206676 | Background | Rybojad B, Sieniawski D, Rybojad P, Samardakiewicz M, Aftyka A. Pain Evaluation in the Paediatric Emergency Department: Differences in Ratings by Patients, Parents and Nurses. Int J Environ Res Public Health. 2022 Feb 21;19(4):2489. doi: 10.3390/ijerph19042489. |
| 39209730 | Background | Reysner M, Reysner T, Janusz P, Kowalski G, Shadi M, Daroszewski P, Wieczorowska-Tobis K, Kotwicki T. Dexamethasone as a perineural adjuvant to a ropivacaine popliteal sciatic nerve block for pediatric foot surgery: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2025 Dec 5;50(12):970-976. doi: 10.1136/rapm-2024-105694. |
| 35144265 | Background | Ozen V, Ozen N. Ultrasound-Guided Pudendal Nerve Block versus Ultrasound-Guided Dorsal Penile Nerve Block for Pediatric Distal Hypospadias Surgery. Urol Int. 2023;107(4):370-376. doi: 10.1159/000521718. Epub 2022 Feb 10. |
| 32507565 | Background | Ozen V, Yigit D. Caudal epidural block versus ultrasound-guided dorsal penile nerve block for pediatric distal hypospadias surgery: A prospective, observational study. J Pediatr Urol. 2020 Aug;16(4):438.e1-438.e8. doi: 10.1016/j.jpurol.2020.05.009. Epub 2020 May 20. |
| 21790518 | Background | Naja Z, Al-Tannir MA, Faysal W, Daoud N, Ziade F, El-Rajab M. A comparison of pudendal block vs dorsal penile nerve block for circumcision in children: a randomised controlled trial. Anaesthesia. 2011 Sep;66(9):802-7. doi: 10.1111/j.1365-2044.2011.06753.x. Epub 2011 Jul 25. |
| 40023044 | Background | Nakamura H, Shimada K, Iwagami M, Masue T, Tamiya N, Inokuchi R. Comparison of regional anesthesia techniques for hypospadias surgery: A systematic review. J Clin Anesth. 2025 Apr;103:111792. doi: 10.1016/j.jclinane.2025.111792. Epub 2025 Feb 28. |
| 39906767 | Background | Melati AC, Wijaya AA. Pudendal nerve block approach for children undergoing urethroplasty. Urol Case Rep. 2025 Jan 15;59:102948. doi: 10.1016/j.eucr.2025.102948. eCollection 2025 Mar. |
| 32134612 | Background | Kinter KJ, Newton BW. Anatomy, Abdomen and Pelvis, Pudendal Nerve. 2023 Feb 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554736/ |
| 28265319 | Background | Keays MA, Dave S. Current hypospadias management: Diagnosis, surgical management, and long-term patient-centred outcomes. Can Urol Assoc J. 2017 Jan-Feb;11(1-2Suppl1):S48-S53. doi: 10.5489/cuaj.4386. |
| 36060359 | Background | Halaseh SA, Halaseh S, Ashour M. Hypospadias: A Comprehensive Review Including Its Embryology, Etiology and Surgical Techniques. Cureus. 2022 Jul 31;14(7):e27544. doi: 10.7759/cureus.27544. eCollection 2022 Jul. |
| 31367075 | Background | Goel P, Jain S, Bajpai M, Khanna P, Jain V, Yadav DK. Does caudal analgesia increase the rates of urethrocutaneous fistula formation after hypospadias repair? Systematic review and meta-analysis. Indian J Urol. 2019 Jul-Sep;35(3):222-229. doi: 10.4103/iju.IJU_252_18. |
| 31855362 | Background | Ghanavatian S, Leslie SW, Derian A. Pudendal Nerve Block. 2024 Sep 2. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK551518/ |
| 21933301 | Background | Ecoffey C. Safety in pediatric regional anesthesia. Paediatr Anaesth. 2012 Jan;22(1):25-30. doi: 10.1111/j.1460-9592.2011.03705.x. Epub 2011 Sep 20. |
| 29489236 | Background | Donaire AE, Mendez MD. Hypospadias. 2023 Jul 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482122/ |
| 38116040 | Background | Dottore B, Meroi F, Tomasino S, Orso D, Comuzzi M, Vernaccini N, Vetrugno L, Intini S, Bove T. Pediatric ultrasound-guided dorsal penile nerve block and sedation in spontaneous breathing: a prospective observational study. Front Med (Lausanne). 2023 Dec 4;10:1268594. doi: 10.3389/fmed.2023.1268594. eCollection 2023. |
| 37539605 | Background | Di Sarno L, Gatto A, Korn D, Pansini V, Curatola A, Ferretti S, Capossela L, Graglia B, Chiaretti A. Pain management in pediatric age. An update. Acta Biomed. 2023 Aug 3;94(4):e2023174. doi: 10.23750/abm.v94i4.14289. |
| 21895855 | Background | Bosenberg A. Benefits of regional anesthesia in children. Paediatr Anaesth. 2012 Jan;22(1):10-8. doi: 10.1111/j.1460-9592.2011.03691.x. Epub 2011 Sep 7. No abstract available. |
| 19468404 | Background | Bhat A, Mandal AK. Acute postoperative complications of hypospadias repair. Indian J Urol. 2008 Apr;24(2):241-8. doi: 10.4103/0970-1591.40622. |
| 38919450 | Background | Bansal T, Yadav N, Singhal S, Kadian Y, Lal J, Jain M. Evaluation of USG-guided novel sacral erector spinae block for postoperative analgesia in pediatric patients undergoing hypospadias repair: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2024 Apr-Jun;40(2):330-335. doi: 10.4103/joacp.joacp_418_22. Epub 2023 Jul 29. |
| 19174373 | Background | Abrahams MS, Aziz MF, Fu RF, Horn JL. Ultrasound guidance compared with electrical neurostimulation for peripheral nerve block: a systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Mar;102(3):408-17. doi: 10.1093/bja/aen384. Epub 2009 Jan 26. |
| ID | Term |
|---|---|
| D007021 | Hypospadias |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided