FindTrial
Sign In

Continuous epidural infusion of local anaesthetic and fentanyl versus epidural morphine boluses for children undergoing upper abdominal surgery

Comparison of the analgesic efficacy of continuous segmental epidural block with dilute local anaesthetic and fentanyl to epidural morphine boluses in dilute local anaesthetic in paediatric patients undergoing upper abdominal surgery– a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044024
Enrollment
60
Registered
2022-07-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Continuous epidural infusion of fentanyl and dilute local anaesthetic: Group II or Study group patients will receive a bolus of 0.2% ropivacaine [0.03-0.04 ml/kg/ segment if age less th

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 2-14 years of ASA physical status I and II undergoing upper abdominal surgery requiring supra umbilical incision.

Exclusion criteria

Exclusion criteria: 1. Parent/ patient refusal. 2. Children with any contraindications to epidural catheter insertion like coagulation abnormality, infection at the site of catheter insertion, allergy to local anaesthetics. 3. Patients with any vertebral, spinal or rib cage abnormality. 4. Patients with pre-existing lung infection. 5. Patients requiring postoperative mechanical ventilation, vasopressor support.

Design outcomes

Primary

MeasureTime frame
To assess cumulative pain at rest over 24 hours postoperatively between the continuous epidural infusion group (fentanyl and dilute local anaesthetic) and the morphine epidural bolus group.Timepoint: 24 hours—

Secondary

MeasureTime frame
1. Sedation score after extubation using Ramsay sedation scale. 2. Assessment of pain scores at rest. 3. Assessment of pain scores on deep breathing. 4. Cumulative pain score on deep breathing over 24 hours. 5.To assess adverse effects related to either technique (nausea, vomiting, pruritus, sedation, respiratory depression, and need for urinary catheterisation). 6.Epidural related adverse effects such as difficulty in threading catheter, visualisation on US, bleeding at time of needle or catheter insertion, accidental dural puncture, perioperative catheter displacement, blockage, insertion site infection. 7.Need for rescue analgesic. 8.To assess lung atelectasis on ultrasound at baseline and 24 hours post- operatively. 9.Parental satisfaction score at 24 hours. Timepoint: Assessment of pain at rest and on deep breathing, PONV and need for supplemental analgesia, sedation, respiratory rate and SpO2 will be done at 1, 2, 4, 6, 12, 18 and 24 hours. Parental satisfaction and ultrasound of lung will be done at 24 hours. Adverse events and cumulative pain scores will be calculated over 24 hours.—

Countries

India

Contacts

Public ContactDr Sumit Singh

All India Institute of Medical Sciences

anjolie5@hotmail.com9810104383

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026