CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 101 enrolled
Drug / intervention
Clonidine +1 moredrug
Likely dose
Clonidine 100 microgramsfrom 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/NCT01846221
NCT01846221Phase 4Completed

Comparison of Fentanyl-bupivacaine and Clonidine-bupivacaine for Breakthrough Pain in Advanced Labor in Patients With Continuous Epidural Analgesia

Columbia University·interventional·Posted May 3, 2013·Updated May 3, 2018

In Brief

A Phase 4 clinical trial evaluating Clonidine and Fentanyl for Labor Pain. Completed, enrolled 101 participants across 1 site.

Detailed Summary

Epidural analgesia has proven to be an effective method for severe pain relief associated with labor and delivery. During labor, a low dose continuous infusion of local anesthetic and narcotic will be administered through an epidural catheter. As labor progresses and the baby's head makes it way through the pelvis, breakthrough pain may emerge and often needs further treatment. The investigators provide pain relief by administering analgesics through the epidural catheter. The patients will be randomly assigned to receive one of two medication mixtures believed to be successful in treating this type of pain associated with advanced labor. After this initial treatment, if pain relief is not attained, the patient may receive the other medication as well. The medications used in this study have been used at this institution for some time and have been found to be safe for mother and baby. The opioid (fentanyl) dose is small and only a small fraction will be transmitted to the baby. The other medication (clonidine) better known as a blood pressure medication has also been used for pain relief. Studies and clinical experience have shown that clonidine when given epidurally in the doses used in this study has minimal, if any effect, on the blood pressure of the mother or of the baby. The investigators will record medical and obstetric history and labor progress relevant to the patient. The patient will be asked questions regarding labor pain and side effects before and after the analgesic is administered. The primary objective is to determine which treatment regimen is more successful in abolishing breakthrough pain in advanced labor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLabor Pain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 3, 2013
Enrollment StartJul 15, 2014
Primary CompletionJan 20, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.2 years ago

Interventions

Clonidinedrug

Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.

Fentanyldrug

Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.