Levobupivacaine to the Surgical Wound Following Cesarean

Phase 3

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: NaCl; Drug: Levobupivacaine

• Registration Number: NCT01458431
• Lead Sponsor: Manuel Ángel Gómez-Ríos

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-10
• Study Start: 2011-10
• Study First Submitted: 2011-10-17
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-24
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-12-20
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl	NaCl	Continuous NaCl subfascial infusion
Levobupivacaine	Levobupivacaine	Continuous levobupivacaine subfascial infusion

Primary Outcome Measures

Name	Time	Method
Area of incisional secondary hyperalgesia	72 hours

Secondary Outcome Measures

Name	Time	Method
Incidence of chronic pain	6 month
Pain relief	72 hours
consumption of morphine (mg) and paracetamol (gr)	48 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
Pharmacokinetic variables of levobupivacaine	72 hours	Cmax, Area Under Curve, Tmax
endocrin-metabolic response	72 hours

Trial Locations

Locations (1)

Teresa Herrera Hospital; A Coruña University Hospital Complex; 🇪🇸 A Coruña, Spain