Infiltration Analgesia After Caesarean Section
|ClinicalTrials.gov Identifier: NCT01094106|
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : January 4, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative Caesarean Section||Drug: Ropivacaine 0,75% Drug: NaCl 0,9%||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Local Infiltration Analgesia for Postoperative Pain After Caesarean Section. A Prospective, Randomised, Controlled Trial|
|Study Start Date :||April 2010|
|Primary Completion Date :||October 2011|
|Study Completion Date :||October 2011|
Active Comparator: Ropivacaine 0,75%
Postoperative wound infusion 15 mg /h / 48h
Drug: Ropivacaine 0,75%
Postoperative wound infusion 2 ml/ h/ 48h
Placebo Comparator: NaCl 0,9%
Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h
Drug: NaCl 0,9%
Postoperative wound infusion 2 ml/h/48h
- The demand of rescue analgesics [ Time Frame: 48 hours ]The amount of opiate analgesics requied 48 hours after operation. Rescue analgesics will be administred when the strength of pain is over 3 on numeric rating scale (NRS) 0-10.
- Strength of pain on numeric rating scale (NRS) [ Time Frame: 48 hours ]
- Postoperative nausea and vomiting (PONV) [ Time Frame: 48 hours ]The vigor of nausea will be assessed on the numeric rating scale (NRS) 0-10. NRS values over 3 will be medicated with antiemetics.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094106
|North Karelia Central hospital|
|Joensuu, Finland, 80880|
|Principal Investigator:||Sakari Syväoja, MD||North Carelia CH, Department of Anesthesia|