Status:
COMPLETED
Levobupivacaine to the Surgical Wound Following Cesarean
Lead Sponsor:
Manuel Ángel Gómez-Ríos
Conditions:
Postoperative Pain
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
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, fat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01458431
Start Date
October 1 2011
End Date
September 1 2014
Last Update
December 23 2014
Active Locations (1)
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1
Teresa Herrera Hospital; A Coruña University Hospital Complex
A Coruña, A Coruña, Spain, 15008