Efficacy of Continuous Infusion of Levobupivacaine to the Surgical Wound Following Cesarean
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Area of incisional secondary hyperalgesia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Levobupivacaine
Continuous levobupivacaine subfascial infusion
干预措施: Levobupivacaine (Drug)
NaCl
Continuous NaCl subfascial infusion
干预措施: NaCl (Drug)
结局指标
主要结局
Area of incisional secondary hyperalgesia
时间窗: 72 hours
次要结局
- Incidence of chronic pain(6 month)
- endocrin-metabolic response(72 hours)
- 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)
研究者
Manuel Ángel Gómez-Ríos
Principal Investigator
Complexo Hospitalario Universitario de A Coruña