2023-507090-18-00招募中4 期
Analgesic efficacy of wound infiltration vs ultrasound-guided transversus abdominis plane block in laparoscopic colorectal surgery
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Difference between total opioid consumption of TAP group versus Wound Infiltration (WI) group 48h. after surgery.
研究概览
简要总结
To compare total perioperative opioid consumption in each of the study groups at 48h expressed as morphine milligram equivalent.
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase IV, single-center, randomized, double-blind clinical trial, compared with clinical practice
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for laparoscopic colorectal surgery (right or left hemicolectomy, extended hemicolectomy, high anterior resection, total colectomy or sigmoidectomy).
- •Age >18 years.
- •Completed informed consent. Patients who agrees to participate in the study by signing the informed consent.
- •Willingness to NOL monitor
排除标准
- •Urgent surgery.
- •Obesity grade II or higher (BMI >35kg/m2).
- •Known allergy to local anesthetics or other drugs included in protocol.
- •Psychiatric disturbances that prevent clinical assessment of pain.
- •Absence of NOL monitor.
- •Previous history of chronic pain with habitual opioid use.
- •If the surgery is converted to open surgery, the patient will be excluded from the study
结局指标
主要结局
Difference between total opioid consumption of TAP group versus Wound Infiltration (WI) group 48h. after surgery.
Difference between total opioid consumption of TAP group versus Wound Infiltration (WI) group 48h. after surgery.
次要结局
- Difference between total opioid consumption of TAP group versus Wound Infiltration (WI) group at post-anesthesia recovery unit (PACU) and 24h after surgery.
- Difference between pain score at rest and movement (by VAS or NRS) of TAP group versus Wound Infiltration (WI) group at post-anesthesia recovery unit (PACU), 24h. and 48h. after surgery.
- Difference between the incidence of nausea and vomiting of TAP group versus Wound Infiltration (WI) group at post-anesthesia recovery unit (PACU), 24h. and 48h. after surgery.
- Difference between the onset of oral tolerance, ambulation movilization and length of hospital stay of TAP group versus Wound Infiltration (WI) group.
研究者
María Cristina Rodríguez Roca
Scientific
Hospital Universitario La Paz
研究点 (1)
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