HypospadiasNCT07575204
Ultrasound-Guided Pudendal vs Dorsal Penile Nerve Block for Pediatric Hypospadias Surgery
A study testing Ultrasound-Guided Pudendal Nerve Block and Ultrasound-Guided Dorsal Penile Nerve Block in people with Hypospadias and Pudendal Nerve Block, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Hypospadias, Pudendal Nerve Block, Penile Nerve Block
- What is being tested?
- Ultrasound-Guided Pudendal Nerve Block and Ultrasound-Guided Dorsal Penile Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 May 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 1 to 6 years.
- Scheduled for hypospadias surgery under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I or II (healthy children or those with mild systemic disease).
- Parents or legal guardians willing to provide written informed consent.
- Patients who meet the study's medical and surgical eligibility after pre-anesthetic evaluation.
Who cannot join
- Allergy to local anesthetics (e.g., bupivacaine).
- Patient or parent refusal to participate.
- Local infection or inflammation at the site of Block placement.
- Anatomical deformities that may interfere with the Block administration.
- Coagulopathy or bleeding disorders.
- Severe systemic conditions (e.g., ASA physical status III or IV).
- History of adverse reactions to nerve blocks or regional anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Ultrasound-Guided Pudendal Versus Dorsal Penile Nerve Block for Postoperative Analgesia in Paediatric Hypospadias Surgery
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:
Read more
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.
Read the detailed description
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.
- Being tested
- Ultrasound-Guided Pudendal Nerve Block, Ultrasound-Guided Dorsal Penile Nerve Block
- Keywords
- Hypospadias, Dorsal penile nerve block, Postoperative analgesia, Pudendal nerve block
- Medical subject headings
- Hypospadias, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Pudendal Nerve BlockProcedure or surgery
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.
Ultrasound-Guided Dorsal Penile Nerve BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ultrasound-Guided Pudendal Nerve Block |
| 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 Receives: Procedure: Ultrasound-Guided Dorsal Penile Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Secondary outcomes (7)
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.
Measured: From the end of surgery to the first analgesic requirement, within the first 24 hours post-surgery.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: From the end of surgery to 24 hours post-surgery, with any complications or adverse events documented during the recovery period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 May 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazi Mahzabin Arin, Bangladesh Medical University
- Investigators
- AKM Akhtaruzzaman, MD, Study director, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575204
- Sponsor's protocol ID
- #5734
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20045849Terkawi 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.
PubMed 24348179Tao 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.
PubMed 38729099Sharara-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.
PubMed 29150457Sridharan 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.
PubMed 40200590Splinter 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.
PubMed 31063627Singh 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.
PubMed 39583595Rybojad 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.
PubMed 35206676Reysner 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.
PubMed 39209730Ozen 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.
PubMed 35144265Ozen 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.
PubMed 32507565Naja 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.
PubMed 21790518Nakamura 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.
PubMed 40023044Melati 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.
PubMed 39906767Kinter 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/
PubMed 32134612
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasound-Guided Pudendal Versus Dorsal Penile Nerve Block for Postoperative Analgesia in Paediatric Hypospadias Surgery
- ClinicalTrials.gov ID
- NCT07575204
- Acronym / sponsor ID
- #5734
- Keywords
- Hypospadias, Dorsal penile nerve block, Postoperative analgesia, Pudendal nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Pudendal Nerve Block Group | Experimental | Procedure: Ultrasound-Guided Pudendal Nerve BlockIn 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 | Procedure: Ultrasound-Guided Dorsal Penile Nerve BlockUltrasound-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 |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients aged 1 to 6 years.
- Scheduled for hypospadias surgery under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I or II (healthy children or those with mild systemic disease).
- Parents or legal guardians willing to provide written informed consent.
- Patients who meet the study's medical and surgical eligibility after pre-anesthetic evaluation.
Key exclusion criteria (7 listed)
- Allergy to local anesthetics (e.g., bupivacaine).
- Patient or parent refusal to participate.
- Local infection or inflammation at the site of Block placement.
- Anatomical deformities that may interfere with the Block administration.
- Coagulopathy or bleeding disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Pudendal Nerve BlockThis 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. | Procedure or surgery | Ultrasound-Guided Pudendal Nerve Block Group |
| Ultrasound-Guided Dorsal Penile Nerve BlockThis 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. | Procedure or surgery | Ultrasound-Guided Dorsal Penile Nerve Block Group |
Primary outcome
Postoperative pain intensity by using Face, Leg, Activity, Cry, Consolability (FLACC) scale
Time frame: 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
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.
7 secondary outcomes
Time to First Postoperative Analgesic Requirement
Time frame: From the end of surgery to the first analgesic requirement, within the first 24 hours post-surgery.
Total Postoperative Analgesic Consumption in the First 24 Hours
Time frame: From the end of surgery to 24 hours post-surgery, with total analgesic consumption recorded at regular intervals.
Hear rate (HR)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: From the end of surgery to 24 hours post-surgery, with any complications or adverse events documented during the recovery period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 20045849Voepel-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.
- Background: PubMed 24348179Terkawi 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.
- Background: PubMed 38729099Tao 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.
- Background: PubMed 29150457Sharara-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.
- Background: PubMed 40200590Sridharan 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.
- Background: PubMed 31063627Splinter 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.
- Background: PubMed 39583595Singh 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.
- Background: PubMed 35206676Rybojad 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.
- Background: PubMed 39209730Reysner 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.
- Background: PubMed 35144265Ozen 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.
- Background: PubMed 32507565Ozen 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.
- Background: PubMed 21790518Naja 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AKM Akhtaruzzaman, MD study director
Bangladesh Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Pudendal Nerve Block and Ultrasound-Guided Dorsal Penile Nerve Block in people with Hypospadias and Pudendal Nerve Block, run by Bangladesh Medical University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity by using Face, Leg, Activity, Cry, Consolability (FLACC) scale (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07575204, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.