Levobupivacaine to the Surgical Wound Following Cesarean

Manuel Ángel Gómez-Ríos

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: Levobupivacaine; Drug: NaCl

Study type: Interventional

Funder types: Other

Identifiers

NCT01458431

MGR-LB-2010-01

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Levobupivacaine

Experimental group

Description:

Continuous levobupivacaine subfascial infusion

Treatment:

Drug: Levobupivacaine

NaCl

Placebo Comparator group

Description:

Continuous NaCl subfascial infusion

Treatment:

Drug: NaCl