Levobupivacaine to the Surgical Wound Following Cesarean

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01458431
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : December 23, 2014
Information provided by (Responsible Party):
Manuel Ángel Gómez-Ríos, Complexo Hospitalario Universitario de A Coruña

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Levobupivacaine Drug: NaCl Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Continuous Infusion of Levobupivacaine to the Surgical Wound Following Cesarean
Study Start Date : October 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Levobupivacaine
Continuous levobupivacaine subfascial infusion
Drug: Levobupivacaine
continuous levobupivacaine subfascial infusion
Other Name: local anesthetic
Placebo Comparator: NaCl
Continuous NaCl subfascial infusion
Drug: NaCl
continuous NaCl subfascial infusion
Other Name: Placebo

Primary Outcome Measures :
  1. Area of incisional secondary hyperalgesia [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Pain relief [ Time Frame: 72 hours ]
  2. consumption of morphine (mg) and paracetamol (gr) [ Time Frame: 48 hours ]
  3. Incidence of chronic pain [ Time Frame: 6 month ]
  4. Pharmacokinetic variables of levobupivacaine [ Time Frame: 72 hours ]
    Cmax, Area Under Curve, Tmax

  5. Incidence of complications and/or side effects related to the technique [ Time Frame: 72 hours ]
  6. Rate of satisfaction experienced by the patients through a survey [ Time Frame: 72 hours ]
  7. endocrin-metabolic response [ Time Frame: 72 hours ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01458431

Teresa Herrera Hospital; A Coruña University Hospital Complex
A Coruña, Spain, 15008
Sponsors and Collaborators
Manuel Ángel Gómez-Ríos
Principal Investigator: Manuel Á gómez-Ríos, MD C.H.U. A Coruña


Responsible Party: Manuel Ángel Gómez-Ríos, Principal Investigator, Complexo Hospitalario Universitario de A Coruña Identifier: NCT01458431     History of Changes
Other Study ID Numbers: MGR-LB-2010-01
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: October 2011

Keywords provided by Manuel Ángel Gómez-Ríos, Complexo Hospitalario Universitario de A Coruña:
cesarean section
wound infusion
Local anesthetic levobupivacaine
Pain management

Additional relevant MeSH terms:
Pain, Postoperative
Surgical Wound
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Wounds and Injuries
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents