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Levobupivacaine to the Surgical Wound Following Cesarean

NCT01458431 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2014-12-23

No results posted yet for this study

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.

Conditions

  • Postoperative Pain

Interventions

DRUG

Levobupivacaine

continuous levobupivacaine subfascial infusion

DRUG

NaCl

continuous NaCl subfascial infusion

Sponsors & Collaborators

  • Manuel Ángel Gómez-Ríos

    lead OTHER

Principal Investigators

  • Manuel Á gómez-Ríos, MD · C.H.U. A Coruña

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01458431 on ClinicalTrials.gov