Levobupivacaine to the Surgical Wound Following Cesarean

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Complexo Hospitalario Universitario de A Coruña.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Manuel Ángel Gómez-Ríos, Complexo Hospitalario Universitario de A Coruña
ClinicalTrials.gov Identifier:
NCT01458431
First received: October 17, 2011
Last updated: October 20, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Postoperative Pain
Drug: continuous levobupivacaina subfascial infusion
Drug: NaCl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Continuous Infusion of Levobupivacaine to the Surgical Wound Following Cesarean

Further study details as provided by Complexo Hospitalario Universitario de A Coruña:

Primary Outcome Measures:
  • Area of incisional secondary hyperalgesia [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain relief [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • consumption of morphine (mg) and paracetamol (gr) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Incidence of chronic pain [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Pharmacokinetic variables of levobupivacaine [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Cmax, Area Under Curve, Tmax

  • Incidence of complications and/or side effects related to the technique [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
  • Rate of satisfaction experienced by the patients through a survey [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • endocrin-metabolic response [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: October 2011
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with continuous levobupivacaine infusion Drug: continuous levobupivacaina subfascial infusion
continuous levobupivacaina subfascial infusion
Other Name: continuous levobupivacaina subfascial infusion
Placebo Comparator: Patients without local anesthetics Drug: NaCl
continuous NaCl subfascial infusion
Other Name: continuous NaCl subfascial infusion

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458431

Contacts
Contact: Manuel Á gómez-Ríos, MD 0034636909413 magoris@hotmail.com

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

Publications:

Responsible Party: Manuel Ángel Gómez-Ríos, Principal Investigator, Complexo Hospitalario Universitario de A Coruña
ClinicalTrials.gov Identifier: NCT01458431     History of Changes
Other Study ID Numbers: MGR-LB-2010-01
Study First Received: October 17, 2011
Last Updated: October 20, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Complexo Hospitalario Universitario de A Coruña:
cesarean section
wound infusion
Local anesthetic levobupivacaine
Pain management

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics, Local
Levobupivacaine
Bupivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014