NCT06213454进行中（未招募）4 期
Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery
研究概览
简要总结
This study is being done to see if preoperative transversus abdominis plane (TAP) analgesia will provide similar postoperative pain control, hospital length of stay, and postoperative outcomes compared to surgeon-initiated wound infiltration with local anesthetic in participants undergoing laparotomy for gynecologic indications.
详细描述
Primary Objective
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on pain control in subjects undergoing laparotomy.
Secondary Objectives
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on subject-rated perception of pain in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on length of hospital stay in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on postoperative anti-emetic use and number of recorded episodes of emesis in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on return of bowel function in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on subject satisfaction in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on postoperative complications in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on readmission rates in subjects undergoing laparotomy.
- To evaluate the cost of care associated with TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on readmission rates in subjects undergoing laparotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and the willingness to sign a written informed consent document
- •Patients undergoing exploratory laparotomy via midline vertical skin incision for gynecologic indications at UW Hospital and Clinics
- •Patients must be >18 years old
- •English speaking (able to provide consent and complete questionnaires)
- •Patients must have the ability to understand visual and verbal pain scales
- •Patients must be eligible for TAP block placement. This will be confirmed during preoperative visit with the primary surgeon. Patient's are not eligible if they have allergies to the anesthetic medications or have had prior abdominal reconstructive surgery that would alter their abdominal wall anatomy in a way where the block would not be expected to be effective.
排除标准
- •Known allergy to local anesthetics.
- •Known history of chronic pain disorders and/or chronic opioid use defined as greater than 10mg of PO morphine or equivalent used daily for at least 30 days prior to enrollment.
- •Patient has a history of opioid dependence requiring rehabilitation or the use of opioid antagonists.
- •Patients with a planned exploration with biopsies (no organs removed) will be excluded from the study.
- •Individuals who are pregnant, lactating or planning on becoming pregnant during the study.
- •Significant liver disease that would inhibit prescription of opioids.
- •Significant kidney disease that would inhibit administration of gabapentin.
- •Not suitable for study participation due to other reasons at the discretion of the investigators.
研究组 & 干预措施
TAP Block plus Laparotomy
Active Comparator
干预措施: TAP Anesthesia (Drug)
Laparotomy plus Local Wound Anesthetic
Active Comparator
干预措施: Surgeon-Initiated Local Anesthetic (Drug)
结局指标
主要结局
Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery
时间窗: 24 hours post-surgery
Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery (including intraoperative and Post Anesthesia Care Unit (PACU) opioid utilization).
次要结局
- Return of bowel function measured in whole hours from completion of surgery to passage of flatus(estimated to be up to 3 days)
- Mean postoperative pain score for the first 24 hours post-surgery(24 hours post-surgery)
- Length of hospital stay, measured in whole hours from admission to PACU to time of discharge order placement(estimated to be up to 3 days)
- Post-operative anti-emetic use(estimated to be up to 3 days)
- Number of recorded episodes of emesis(estimated to be up to 3 days)
- Participant Satisfaction at Postoperative Visit measured by two pain questions from the QoR-15 Patient Reported Outcomes Survey Score(post-operative visit (up to 60 days))
- Readmission rate measured by readmission in the 30 days following surgery(up to 30 days)
- Cost of care measured by aggregate cost of hospitalization following discharge from surgical hospital stay(estimated to be up to 3 days)
- Summary of Post-operative Complications(up to 30 days post-operatively)
- Time to First Ambulation measured in hours(estimated to be within 72 hours post-surgery)
研究者
研究点 (1)
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