Methylprednisolone Versus Dexamethasone in Pediatric Caudal Block

Overview

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.

Full Title of Study: “Efficacy and Safety of Methylprednisolone Versus Dexamethasone in Caudal Block for Children Undergoing Hypospadias Surgical Repair: A Bi-center Randomized Controlled Study”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Outcomes Assessor)
• Study Primary Completion Date: November 1, 2023

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. In pediatric surgical patients presenting for mainly lower abdominal surgery, a meta-analysis revealed clinically meaningful prolongation of the duration of analgesia from caudal blockade by adjuvant dexamethasone versus placebo. In addition to doubling to tripling the duration of analgesia, adjuvant dexamethasone has a rescue analgesia sparing effect and reduces post postoperative nausea and vomiting. A vast majority of literature supports the efficacy of particulate steroids like methylprednisolone over dexamethasone in providing longer analgesia in management of chronic pain conditions. Aim of the work and hypothesis: To the best of our knowledge, this is the first study that will evaluate the analgesic efficacy and safety of caudal methylprednisolone in pediatric patients. 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. The investigators hypothesize that methylprednisolone will provide superior postoperative analgesia than dexamethasone when added to bupivacaine for caudal block.

Interventions

• Drug: caudal block using dexamethasone
  • patient will receive 0.5 ml/kg volume (bupivacaine 0.25 % + dexamethasone 0.1mg/kg) through the sacral hiatus
• Drug: caudal block using methylprednisolone
  • patients will receive 0.5 ml/kg volume (bupivacaine 0.25% + methylprednisolone 0.5mg/kg) through the sacral hiatus

Arms, Groups and Cohorts

• Active Comparator: Group Dexamethasone
  • will receive 0.5 ml/kg volume (bupivacaine 0.25 % + dexamethasone 0.1mg/kg) for caudal block
• Experimental: Group Methylprednisolone
  • will receive 0.5 ml/kg volume (bupivacaine 0.25% + methylprednisolone 0.5mg/kg) for caudal block

Clinical Trial Outcome Measures

Primary Measures

• duration of analgesia
  • Time Frame: Up to 24 hours after the procedure]
  • first need for rescue analgesia will be recorded

Secondary Measures

• the severity of postoperative pain according to FLACC score
  • Time Frame: Up to 24 hours after the procedure]
  • Pain levels will be assessed post operatively using the 10-point behavioral face, leg, activity, cry, consolability (FLACC) pain scale, with a minimum score of 0 and a maximum of 10 at 0,1, 2, 4, 6, 12, 24 hours
• side effects
  • Time Frame: Up to 24 hours after the procedure]
  • side effects including nausea and vomiting, respiratory depression, hyperglycemia

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 1 Year

Maximum Age: 6 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Mansoura University
• Provider of Information About this Clinical Study
  • Principal Investigator: Mahmoud Mohammed Alseoudy, Lecturer of anesthesia, ICU & pain management; Faculty of Medicine – Mansoura University
• Overall Contact(s)
  • Mahmoud M Alseoudy, MD, +201006224551, drs3ody.mansora@mans.edu.eg