Infiltration Analgesia After Caesarean Section

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Postoperative, Caesarean Section

Intervention / Treatment
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* Drug: Ropivacaine 0,75%
* Drug: NaCl 0,9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: volunteer age over 18 years spinal anesthesia ASA 1-2 no allergy to used medications no medications which have effect on pain perception Exclusion Criteria: patient's refusal to participate marked systemic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine 0,75%<br>Postoperative wound infusion 15 mg /h / 48h | Drug: Ropivacaine 0,75%<br>* Postoperative wound infusion 2 ml/ h/ 48h<br>|
| Placebo Comparator: NaCl 0,9%<br>Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h | Drug: NaCl 0,9%<br>* Postoperative wound infusion 2 ml/h/48h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Demand of Rescue Analgesics (Oxycodone) | The amount of oxycodone required 48 hours after operation. Oxycodone was administered when the strength of pain is over 3 on numeric rating scale (NRS) 0-10. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength of Pain on Numerical Rating Scale (NRS) | Intensity of pain was recorded on a numerical rating scale (0-10), where higher scores mean more severe pain, during rest and when moving, for five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h); for each time interval, the highest recorded pain score was taken into account. | 48 hours, divided to five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h) | 
| Postoperative Nausea and Vomiting (PONV) | The numbers of patients with at least mild nausea at any time post-operatively. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, infiltration analgesia, ropivacaine, Caesarean Section