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Completed

NCT Number: NCT01458431

Levobupivacaine to the Surgical Wound Following Cesarean

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.

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Key information

Conditions

Postoperative Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Teresa Herrera Hospital; A Coruña University Hospital Complex

A Coruña, 15008, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levobupivacaine

Drug

continuous levobupivacaine subfascial infusion

Other names: local anesthetic

NaCl

Drug

continuous NaCl subfascial infusion

Other names: Placebo

Primary outcomes

  1. Area of incisional secondary hyperalgesia

    Time frame: 72 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Manuel Ángel Gómez-Ríos

Other

Registry information

Official study title

Efficacy of Continuous Infusion of Levobupivacaine to the Surgical Wound Following Cesarean

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 24, 2011
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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