Postoperative Pain
Conditions
Keywords
cesarean section, wound infusion, Local anesthetic levobupivacaine, Pain management
Brief 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.
Interventions
DRUGLevobupivacaine
continuous levobupivacaine subfascial infusion
DRUGNaCl
continuous NaCl subfascial infusion
Sponsors
Manuel Ángel Gómez-Ríos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area of incisional secondary hyperalgesia | 72 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| consumption of morphine (mg) and paracetamol (gr) | 48 hours | — |
| Incidence of chronic pain | 6 month | — |
| Pharmacokinetic variables of levobupivacaine | 72 hours | Cmax, Area Under Curve, Tmax |
| Pain relief | 72 hours | — |
| Rate of satisfaction experienced by the patients through a survey | 72 hours | — |
| endocrin-metabolic response | 72 hours | — |
| Incidence of complications and/or side effects related to the technique | 72 hours | — |
Countries
Spain
Outcome results
None listed