CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 70 enrolled
Drug / intervention
Levobupivacaine +1 moredrug
Likely dose
Not stated in 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/NCT01458431
NCT01458431Phase 3Completed

Efficacy of Continuous Infusion of Levobupivacaine to the Surgical Wound Following Cesarean

Manuel Ángel Gómez-Ríos·interventional·Posted Oct 24, 2011·Updated Dec 23, 2014

In Brief

A Phase 3 clinical trial evaluating Levobupivacaine and NaCl for Postoperative Pain. Completed, enrolled 70 participants across 1 site.

Detailed Summary

The postoperative period following cesarean is associated with moderate to severe pain that requires a considerable amount of analgesics that carry with them side-effects such as nausea, vomiting, fatigue and immobilization. Several studies have tried, with variable results, to find a more effective analgesia alternative such as infusion of local anesthetics through a catheter in the surgical wound sinus, a practice that has currently been widely used in clinical practice. Despite existing references on its use in the postoperative period following cesareans there continues to be a lack of information on other aspects. The investigators study hypothesis is that the use of levobupivacaine in the surgical wound will reduce the surface of hyperalgesia compared to the control group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 24, 2011
Enrollment StartOct 1, 2011
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 14.7 years ago

Interventions

Levobupivacainedrug

continuous levobupivacaine subfascial infusion

NaCldrug

continuous NaCl subfascial infusion