CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 94 enrolled
Drug / intervention
Ropivacaine/Fentanyl +1 moredrug
Likely dose
Ropivacaine/Fentanyl 5 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03444636
NCT03444636Phase 4Completed
CompareCT.gov

The Efficacy and Safety of Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy - a Prospective Randomized Study

National Institute for Tuberculosis and Lung Diseases, Poland·interventional·Posted Feb 23, 2018·Updated May 28, 2020

In Brief

A Phase 4 clinical trial evaluating Ropivacaine/Fentanyl and Bupivacaine/Fentanyl for Pain, Postoperative and Surgery, Thoracic. Completed, enrolled 94 participants across 1 site.

Detailed Summary

The study was performed in patients aged 6-18 years after the Ravitch procedure and thoracotomy. The primary aim of the study was to evaluate the efficacy and safety of pain control provided by the multimodal approach that involves the continuous infusion ropivacaine with fentanyl vs. bupivacaine with fentanyl through thoracic epidural catheter. Secondary aims were to identify the determinants of acute post-operative pain at rest, during deep breathing and coughing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative, Surgery, Thoracic
CountriesPoland
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 23, 2018
Enrollment StartMar 2, 2015
Primary CompletionMar 14, 2017
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.4 years ago

Interventions

Ropivacaine/Fentanyldrug

Ropivacaine 0.2% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr

Bupivacaine/Fentanyldrug

Bupivacaine 0.125% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr