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NCT Number: NCT07747038

Caudal Block v/s Local Wound Infiltration for Pain Control in Pediatric Patients After Operation for Inguinal Hernia

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lahore, Punjab Province, Pakistan

About this study

Pediatric patients undergoing inguinal hernia surgeries experience postoperative pain. Conventional pain management methods, including opiates, may pose significant side effects. This study addresses the imperative need for optimizing postoperative pain management by systematically investigating and comparing the analgesic effects of local wound infiltration versus caudal block. The study involves 100 patients allocated into two equal groups using a lottery method: one group receiving caudal block; and other group local wound infiltration . 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Caudal Block with Ropivacaine Intervention

Drug

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

Local Wound Infiltration with Ropivacaine Intervention

Drug

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

Intravenous Paracetamol Suspension Intervention

Drug

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.

Primary outcomes

  1. Postoperative Analgesic Requirement

    Time frame: Within first 8 hours after surgery

    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.

  2. Postoperative Analgesia requirement

    Time frame: Within first 8 hours after surgery

    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.

Sponsors and collaborators

Lead sponsor

Fatima Memorial Hospital

Other

Registry information

Official study title

COMPARISON OF ANALGESIC EFFECTS OF WOUND INFILTRATION WITH ROPIVACAINE VERSUS CAUDAL BLOCK WITH ROPIVACAINE IN PEDIATRIC PATIENTS UNDERGOING INGUINAL HERNIOTOMY INTRODUCTION

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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