Transversus Abdominis Plane Block vs. Local Wound Infiltration for Elective Laparoscopic Cholecystectomy in Children and Adolescents: A Prospective Randomized-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Time to first request of pain medication
研究概览
简要总结
The objective of this study is to compare transversus abdominis plane (TAP) blocks to local wound infiltration (LWI) in terms of postoperative pain control in pediatric patients undergoing elective laparoscopic cholecystectomy. Our hypothesis is that TAP blocks will be superior to LWI for postoperative pain control resulting in decreased use of opioid / narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative period. The rationale is that determining the effect of analgesia in this pediatric population is important to optimize clinical care.
详细描述
In this study, patients ages 8 through 17 years scheduled for elective laparoscopic cholecystectomy will be invited to participate. Those having da Vinci cholecystectomy procedures will also be eligible. The da Vinci System is a minimally invasive option utilizing robotic technology. Once randomized, the patient will undergo either ultrasound guided bilateral TAP blocks or LWI at the beginning of the surgical procedure. Prospective data regarding pain scores, use of opioid medication, and nausea and vomiting episodes will be collected for both groups. Due to the nature of the study, it will not be possible to blind the investigators to the randomly selected method of injecting local anesthesia; however the personnel involved in the post-anesthetic and post-operative assessment will be blinded to the intervention, as well as the subjects themselves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8-17 yrs of age at date of enrollment.
- •Elective laparoscopic or da Vinci cholecystectomy scheduled for any diagnostic reason.
排除标准
- •Chronic pain or chronic use of narcotic or other prescription pain medications.
- •Use of pain medication within 24 hours before surgery
- •Prior major abdominal surgery
- •Evidence of acute inflammation
- •Patients with acute cholecystitis
- •Bleeding / coagulation disorder
- •Seizure disorder
- •Renal dysfunction
- •Infection at injection sites for TAP block or trocar placement
- •Contraindication to LWI or TAP block procedure, as determined by surgeon or anesthesiologist performing the procedure (including, but not limited to, previous incision distorting anatomy or inability to visualize anatomical planes)
- •Any known allergy to medications used in this study
- •Patient unable to verbalize pain score or independently assess pain level
- •Unstable patient in need of emergent intervention at surgeon discretion
- •Patients who are known to be pregnant
- •Patients who are currently prisoners
- •Children in custody of the state
- •Subjects will a BMI >/= 50
- •Investigator discretion for any other reason
结局指标
主要结局
Time to first request of pain medication
时间窗: From post-anesthesia care unit "(PACU) in" time to first pain medication dose, up to 24 hours
Amount of narcotic pain medication
时间窗: 24 hours post-op
次要结局
未报告次要终点
研究者
Brian Wallace Gray
Pediatric surgeon
Indiana University