Efficacy and Safety of Methylprednisolone Versus Dexamethasone in Caudal Block for Children Undergoing Hypospadias Surgical Repair: A Bi-center Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mansoura University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- duration of analgesia
Study Overview
Brief Summary
This randomized, double-blind, controlled bi-center study was designed to compare the postoperative analgesic efficacy of dexamethasone and methylprednisolone in caudal block for children undergoing hypospadias surgical repair using the duration of analgesia as the primary outcome. We hypothesize that methylprednisolone will provide superior postoperative analgesia than dexamethasone when added to bupivacaine for caudal block. This study will be conducted on 80 male patients of American Society of Anesthesiologists physical status I-II of with their age ranging from 1 to 6 years scheduled for surgical repair of hypospadias. The patients will be randomly assigned into 2 groups:- Group D: will receive 0.5 ml/kg volume (bupivacaine 0.25 % + dexamethasone 0.1mg/kg) Group M: will receive 0.5 ml/kg volume (bupivacaine 0.25% + methylprednisolone 0.5mg/kg) The main collected data will be the duration of analgesia (first need for rescue analgesia ), the severity of postoperative pain according to FLACC and the side effects like nausea and vomiting, respiratory depression.
Detailed Description
Hypospadias repair surgery is an invasive surgery that results in significant postoperative pain. pain alters the quality of life and satisfaction of the patients and results in manipulation of wounds, infection, bleeding, and wound dehiscence leading to unfavorable surgical outcome .
As a plan for postoperative pain prophylaxis in children, different analgesic techniques have been used as preemptive analgesia such as local infiltration of anesthesia, penile block, epidural block and caudal block in addition to general anesthesia. Caudal block is found to be one of most succeeded technique in hypospadias repair and decreases the postoperative analgesia consumption.
Bupivacaine is a local anesthetic commonly used via caudal epidural route but gives limited duration of analgesia. Therefore, the addition of other drugs in an attempt to improve the quality and duration of analgesia given by bupivacaine has been studied.
Examples of additives drugs used in the caudal epidural are opioids, alpha 2 agonist as dexmedtomidine and clonidine which produce prolongation of the duration of the analgesia, but their undesirable effect may limit its use as nausea, vomiting, pruritus, urinary retention and respiratory depression.
Epidural corticosteroids have a long history of safe and effective use in the treatment of low back and radicular pain due to their strong anti-inflammatory effect encouraging use in management of acute postoperative pain.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The study subjects and the resident assessing the outcomes will be blinded to the study group. A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation
Eligibility Criteria
- Ages
- 1 Year to 6 Years (Child)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male patients
- •American Society of Anesthesiologists physical status I-II of
- •age ranging from 1 to 6 years
- •scheduled for surgical repair of hypospadias
Exclusion Criteria
- •a history of neurodevelopmental delay
- •type I diabetes
- •coagulopathy
- •known allergy to any local anesthetic or steroid,
- •known congenital anomaly of the spine and local infection.
Arms & Interventions
Group Dexamethasone
will receive 0.5 ml/kg volume (bupivacaine 0.25 % + dexamethasone 0.1mg/kg) for caudal block
Intervention: caudal block using dexamethasone (Drug)
Group Methylprednisolone
will receive 0.5 ml/kg volume (bupivacaine 0.25% + methylprednisolone 0.5mg/kg) for caudal block
Intervention: caudal block using methylprednisolone (Drug)
Outcomes
Primary Outcomes
duration of analgesia
Time Frame: Up to 24 hours after the procedure]
first need for rescue analgesia will be recorded
Secondary Outcomes
- the severity of postoperative pain according to FLACC score(Up to 24 hours after the procedure])
- side effects(Up to 24 hours after the procedure])
Investigators
Mahmoud Mohammed Alseoudy
Lecturer of anesthesia, ICU & pain management; Faculty of Medicine
Mansoura University