NCT07747038

Brief Summary

This randomized controlled trial aims to compare the analgesic efficacy of local wound infiltration with Ropivacaine versus Caudal Block with Ropivacaine in pediatric patients undergoing surgery for inguinal hernia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
Last Updated

August 5, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 31, 2026

Last Update Submit

July 31, 2026

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

  • Postoperative Analgesic Requirement

    Post-operative pain will be assessed at 30 minutes, and 1, 2, 4, 6, and 8 hours using the Hannallah Modified Objective Pain Scale. At any stage, if a pain score of 3 or more is observed, it will be considered severe pain, and rescue analgesia in intravenous paracetamol suspension at 15 ml/kg body weight will be administered.

    Within first 8 hours after surgery

  • Postoperative Analgesia requirement

    Post-operative pain will be assessed at 30 minutes, and 1, 2, 4, 6, and 8 hours using the Hannallah Modified Objective Pain Scale. At any stage, if a pain score of 3 or more is observed, it will be considered severe pain, and rescue analgesia in intravenous paracetamol suspension at 15 ml/kg body weight will be administered.

    Within first 8 hours after surgery

Study Arms (2)

Group A: Caudal Block Group

EXPERIMENTAL

Pediatric patients undergoing open elective inguinal herniotomy who receive a post-operative caudal block.

Drug: Caudal Block with Ropivacaine InterventionDrug: Intravenous Paracetamol Suspension Intervention

Group B: Local wound infiltration

ACTIVE COMPARATOR

Pediatric patients undergoing open elective inguinal herniotomy who receive post-operative local wound infiltration.

Drug: Local Wound Infiltration with Ropivacaine InterventionDrug: Intravenous Paracetamol Suspension Intervention

Interventions

Caudal Block with Ropivacaine InterventionDRUG

Administered after surgery using the landmark technique with 0.25% ropivacaine at a dose of 2mg/kg body weight.

Group A: Caudal Block Group
Local Wound Infiltration with Ropivacaine InterventionDRUG

Administered after surgery by pediatric surgeons using 0.5% ropivacaine at a dose of 2mg/kg body weight into the groin skin crease incision.

Group B: Local wound infiltration
Intravenous Paracetamol Suspension InterventionDRUG

Administered as rescue analgesia at a dose of 15 ml/kg body weight if the patient's postoperative pain score reaches 3 or higher on the Hannallah Modified Objective Pain Scale.

Group A: Caudal Block GroupGroup B: Local wound infiltration

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male and female patients aged 2-10 years.
  • Patients undergoing open elective herniotomy.
  • Patients classified as ASA (American Society of Anesthesiologists) classes I and II.

You may not qualify if:

  • Patients with recurrent, bilateral, complicated, or obstructed hernias.
  • History of bleeding disorders.
  • Presence of congenital anomalies of the spine.
  • History of drug allergy.
  • Infection at the caudal injection site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia, Fatima Memorial Hospital Lahore, Punjab, Pakistan, 54000

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
COMPARISON OF ANALGESIC EFFECTS OF WOUND INFILTRATION WITH ROPIVACAINE VERSUS CAUDAL BLOCK WITH ROPIVACAINE IN PEDIATRIC PATIENTS UNDERGOING INGUINAL HERNIOTOMY INTRODUCTION

Study Record Dates

First Submitted

July 31, 2026

First Posted

August 5, 2026

Study Start

July 1, 2025

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

August 5, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)