Levobupivacaine to the Surgical Wound Following Cesarean

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Levobupivacaine
* Drug: NaCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full-term pregnant women who undergo scheduled cesarean surgery under intradural anesthesia. Duly informed patients who have signed the informed consent during the preanesthesia consultation, or after a period of consideration if necessary, expressing their consent to be included in the study. Between 18-45 years of age. ASA I and II. Sufficient intellectual ability to understand the technique as well as the equipment being used. Exclusion Criteria: Failure to meet any of the above criteria. Presence of a major medical, cardiovascular, pulmonary, metabolic, renal or liver disorder. Preeclampsia and/or HELLP syndrome. Coagulopathy Profuse bleeding greater than 1000 ml or that which provokes hemodynamic instability that requires aggressive fluid therapy and/or transfusion. Allergy to any drug included in the protocol. Psychiatric or neurological pathology. Preexisting infection. Previous treatment with opioids or antidepressants or suffer from chronic pain. History of alcohol or drug abuse or known consumption of medications that interfere with LB metabolism.

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 |
| --- | --- |
| Experimental: Levobupivacaine<br>Continuous levobupivacaine subfascial infusion | Drug: Levobupivacaine<br>* continuous levobupivacaine subfascial infusion<br>* Other names: local anesthetic;|
| Placebo Comparator: NaCl<br>Continuous NaCl subfascial infusion | Drug: NaCl<br>* continuous NaCl subfascial infusion<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area of incisional secondary hyperalgesia |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief |  | 72 hours | 
| consumption of morphine (mg) and paracetamol (gr) |  | 48 hours | 
| Incidence of chronic pain |  | 6 month | 
| Pharmacokinetic variables of levobupivacaine | Cmax, Area Under Curve, Tmax | 72 hours | 
| Incidence of complications and/or side effects related to the technique |  | 72 hours | 
| Rate of satisfaction experienced by the patients through a survey |  | 72 hours | 
| endocrin-metabolic response |  | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, wound infusion, Local anesthetic levobupivacaine, Pain management