The Effect of Intravenous Infusion of Tramadol-ondansetron on Recovery After Caesarean Section. A Prospective, Observational and Non-inferiority Study Against Epidural Analgesia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Post-surgical recovery
研究概览
简要总结
It will be a prospective observational cohort study. The investigators will compare post-cesarean section recovery in patients receiving intravenous infusion of tramadol-ondansetron versus epidural catheter with infusion of local anesthetics.
详细描述
The primary outcome is to assess the non-inferiority in terms of post-cesarean section recovery of the intravenous perfusion of tramadol + ondansetron compared to the perfusion of local anesthetics through an epidural catheter.
This will be a prospective observational cohort study, with a total N of 312 patients who underwent a cesarean section. 156 who maintain the epidural catheter as the main measure of analgesia for 24 h, and 156 who receive an infusion of tramadol-ondansetron from the end of the cesarean section and for the following 24 h. The following data will be collected at 24 and 48 hours: need for unscheduled pharmacological reinforcement, adverse effects, QoR (Quality of Recovery) score 15, ObsQor-10 (Obstetric Quality of Recovery) score, and Visual Analogue Pain Scale (VAS) every 4 hours for 48 hours. The incidence of chronic pain 90 days after cesarean section will be assessed using the Numerical Pain Rating Scale (NRS).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman over 18 years old undergoing caesarean section
- •She agrees to participate voluntarily.
- •She is already receiving any of the analgesic strategies studied.
排除标准
- •Receiving an analgesic medication other than the one mentioned as "routine multimodal analgesia" (either as regular medication or for acute post-surgical pain)
- •Medical history that determines the baseline data of the scales and data that we collect ( pain or previous disabilities; addiction to drugs, alcohol or drugs; another disease that worsens the quality of life)
- •Medical history that conditions the pharmacological effect (allergy, intolerance or atypical reaction to any of the drugs involved in its treatment or possible cross-reactions )
- •Contraindication for neuraxial techniques (patient refusal, difficulty in understanding or communication, localized infection, increased intracranial pressure, or other medical criteria)
- •Two or more previous caesarean sections
- •Difficulty in understanding or communication
- •Mother care will not be available to the newborn in the postpartum period for any reason
研究组 & 干预措施
TRON (Tramadol-Ondansetron)
Women who receive an infusion of tramadol-ondansetron from the end of the cesarean section and for the following 24 h. The infusion (TRON) is composed of 300 mg of tramadol and 12 mg of ondansetron dissolved in 250 ml of 0.9% saline, which is routinely programmed at 11 ml/h until the content is exhausted (approximately 23 hours).
干预措施: Tramadol-ondansetron continuous infusion (Drug)
AL-EPI (Local anesthetics via epidural)
Women who maintain the epidural catheter as the main measure of analgesia for 24 h. The epidural catheter after caesarean section is programmed with a 0.2% ropivacaine PCA (Patient controlled analgesia) pump at 7 ml/h with 7 ml on-demand boluses, with block every 20 min.
干预措施: Ropivacaine via epidural catheter (Drug)
结局指标
主要结局
Post-surgical recovery
时间窗: Day 1
QoR-15 score at 24 hours after cesarean section
次要结局
- Analgesia for acute pain(Day 2)
- Quality of recovery using ObsQoR10 - Spanish version(Day 1)
- Adverse effects(Day 2)
- Post-surgical recovery(Day 2)
- Chronic Pain(Day 90)
研究者
Oscar Diaz-Cambronero
Principal Investigator. Head of the perioperative medicine group. Coordinator of the Clinical Medicine Unit
Hospital Universitario La Fe