CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
Ropivacaine 0,75% +1 moredrug
Likely dose
Ropivacaine 0,75% 2 mlfrom 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/NCT01094106
NCT01094106Phase 4Completed

Local Infiltration Analgesia for Postoperative Pain After Caesarean Section. A Prospective, Randomised, Controlled Trial

North Karelia Central Hospital·interventional·Posted Mar 26, 2010·Updated Aug 18, 2020

In Brief

A Phase 4 clinical trial evaluating Ropivacaine 0,75% and NaCl 0,9% for Pain, Postoperative and Caesarean Section. Completed, enrolled 70 participants across 1 site.

Detailed Summary

Infiltration of a local anesthetic into the surgical wound is a simple method to strive to control postoperative pain after surgery. In the investigators institution, this method is used quite often. However, there is a controversy regarding the analgesic efficacy. Moreover, the cost of the single use elastomeric pump used with this procedure is clearly higher than the costs of other routinely used analgesic methods. According to the investigators observations, infiltration of a local anesthetic into the surgical wound after caesarean section seems to reduce the need for rescue analgesics. However, the scientific evidence of the efficacy of this technique is weak. The investigators decided to conduct a prospective, controlled, randomised, double blind trial on this topic. The hypothesis is that wound infiltration with local anesthetic will reduce postoperative pain and opioid consumption after caesarean section without major adverse effects.

Study Details

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

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2010
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.3 years ago

Interventions

Ropivacaine 0,75%drug

Postoperative wound infusion 2 ml/ h/ 48h

NaCl 0,9%drug

Postoperative wound infusion 2 ml/h/48h