Methylprednisolone Versus Dexamethasone in Pediatric Caudal Block

Sponsor

Mansoura University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05717374

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caudal Block	Drug: caudal block using dexamethasone Drug: caudal block using methylprednisolone	N/A

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 (1).

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 (2).

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 (3).

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 (4).

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 (5).

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 (6).

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 (7).

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. We hypothesize that methylprednisolone will provide superior postoperative analgesia than dexamethasone when added to bupivacaine for caudal block.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, randomized, double blind studyProspective, randomized, double blind study

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

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group D will receive 0.5 ml/kg volume (bupivacaine 0.25 % + dexamethasone 0.1mg/kg) for caudal block	Drug: caudal block using dexamethasone patient will receive 0.5 ml/kg volume (bupivacaine 0.25 % + dexamethasone 0.1mg/kg) through the sacral hiatus Other Names: caudal dexamethasone
Experimental: Group M will receive 0.5 ml/kg volume (bupivacaine 0.25% + methylprednisolone 0.5mg/kg) for caudal block	Drug: caudal block using methylprednisolone patients will receive 0.5 ml/kg volume (bupivacaine 0.25% + methylprednisolone 0.5mg/kg) through the sacral hiatus Other Names: caudal methylprednisolone

Arm

Intervention/Treatment

Active Comparator: Group D

will receive 0.5 ml/kg volume (bupivacaine 0.25 % + dexamethasone 0.1mg/kg) for caudal block

Drug: caudal block using dexamethasone

patient will receive 0.5 ml/kg volume (bupivacaine 0.25 % + dexamethasone 0.1mg/kg) through the sacral hiatus

Other Names:

caudal dexamethasone

Experimental: Group M

will receive 0.5 ml/kg volume (bupivacaine 0.25% + methylprednisolone 0.5mg/kg) for caudal block

Drug: caudal block using methylprednisolone

patients will receive 0.5 ml/kg volume (bupivacaine 0.25% + methylprednisolone 0.5mg/kg) through the sacral hiatus

Other Names:

caudal methylprednisolone

Outcome Measures

Primary Outcome Measures

duration of analgesia [Up to 24 hours after the procedure]]
first need for rescue analgesia will be recorded

Secondary Outcome Measures

the severity of postoperative pain according to FLACC score [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 [Up to 24 hours after the procedure]]
side effects including nausea and vomiting, respiratory depression, hyperglycemia