Rectus Sheath Block With Liposomal Bupivacaine for Postoperative Analgesia Following Gynecologic Oncology Surgery: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative opioid consumption 0- 72 hours after surgery
研究概览
简要总结
Thirty subjects undergoing laparotomy for Gynecologic oncology surgery will be prospectively enrolled and will receive a bilateral rectus sheath block (RSB) under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side. Cases will be matched in a 1:2 ratio by age, race, insurance status and duration of surgery with historical controls who received postoperative analgesia using thoracic epidural analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients ≥18 years presenting for a laparotomy for Gynecologic malignancy with a vertical incision.
- •ASA Classification II or III.
- •English speaking patients
排除标准
- •BMI >50 kg/m
- •Chronic pain or chronic opioid therapy.
- •Allergy or contraindication to local anesthetics or any component of the multimodal analgesic regimen (NSAIDs and acetaminophen)
研究组 & 干预措施
Rectus Sheath Block Group (Prospective arm)
Thirty subjects will be prospectively enrolled and will receive a bilateral rectus sheath block under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side.
干预措施: Rectus sheath block (Procedure)
Rectus Sheath Block Group (Prospective arm)
Thirty subjects will be prospectively enrolled and will receive a bilateral rectus sheath block under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side.
干预措施: Liposomal bupivacaine (Drug)
Rectus Sheath Block Group (Prospective arm)
Thirty subjects will be prospectively enrolled and will receive a bilateral rectus sheath block under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side.
干预措施: Bupivacaine Hydrochloride (Drug)
Thoracic Epidural Analgesia Group (retrospective arm)
60 patients who received thoracic epidural analgesia as part of our enhanced recovery after surgery protocol and stayed in hospital for at least 72 h.
干预措施: Thoracic Epidural Analgesia (Procedure)
Thoracic Epidural Analgesia Group (retrospective arm)
60 patients who received thoracic epidural analgesia as part of our enhanced recovery after surgery protocol and stayed in hospital for at least 72 h.
干预措施: Bupivacaine-Hydromorphone Cassette (Drug)
结局指标
主要结局
Postoperative opioid consumption 0- 72 hours after surgery
时间窗: 0-72 hours after time 0 (end of surgery)
次要结局
- Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores through 72 hours (AUC0-72)(0-72 hours after time 0 (end of surgery))
- Maximum pain scores reported(0-72 hours after time 0 (end of surgery))
- Time to mobilization(0-72 hours after time 0 (end of surgery))
- Total postsurgical opioid consumption at 0-24, 24-48, and 48-72 hours(0-24 hours, 24-48 hours and 48-72 hours after time 0 (end of surgery))
- Number of patients receiving rescue antiemetics(0-72 hours after time 0 (end of surgery))
- Number of patients receiving intraoperative vasopressors(Intraoperative)
- Number of patients with intraoperative hypotension(Intraoperative)
- Number of patients developing ileus or constipation(0-72 hours after time 0 (end of surgery))
- Number of patients with respiratory Depression(0-72 hours after time 0 (end of surgery))
- Time to urinary catheter removal(0-72 hours after time 0 (end of surgery))
- Duration of post anesthesia care unit (PACU) stay(0-6 hours after time 0 (end of surgery))
- Duration of hospital stay(0-10 days after surgery)
- Number of patients with postoperative hypotension(0-72 hours after time 0 (end of surgery))
- Number of patients receiving rescue antipruritics(0-72 hours after time 0 (end of surgery))