Effectiveness of Ultrasound-Guided Pudendal Versus Dorsal Penile Nerve Block for Postoperative Analgesia in Paediatric Hypospadias Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
Kazi Mahzabin Arin
Assistant Professor
Bangladesh Medical University