Wound Infiltration With Liposomal Bupivacaine With or Without Intrathecal Analgesia in Laparotomy for Gynecological Malignancy: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Overall Benefit of Analgesia Score (OBAS)
研究概览
简要总结
This phase IV trial studies how well liposomal bupivacaine with or without hydromorphone works in improving pain control during the first 24 hours after surgery in patients with gynecological malignancies undergoing laparotomy. Liposomal bupivacaine is routinely infiltrated into the skin surrounding the abdominal incision, and is effective in providing good relief of incisional pain. Hydromorphone is also a type of pain medication that may provide better management of deep abdominal pain. It is not yet known if giving liposomal bupivacaine with or without hydromorphone will work better in improving pain in patients with gynecological malignancies during the first 24 hours after surgery.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate if no additional intervention is noninferior to intrathecal analgesia (ITA) for postoperative pain experience 24 hours after surgery after laparotomy for gynecological malignancy within an established enhanced recovery pathway which includes incisional liposomal bupivacaine (ILB).
II. Evaluate the effect of intrathecal analgesia on patient satisfaction with postoperative analgesia after laparotomy for gynecological malignancy.
III. Report the impact of ITA use on cost. IV. Validate the Quality of Recovery (QOR)-15 in our population.
OUTLINE: Patients are randomized to 1 of 2 arms.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective surgery for suspected (based on consulting surgeon's opinion-imaging, laboratory [lab], pathology [path]) gynecological malignancy, enhanced recovery after surgery (ERAS) protocol
排除标准
- •Inability to read or understand English
- •Prehospitalization narcotic use if weekly average daily oral morphine equivalent of > 20 mg
- •Chronic pain syndromes such as fibromyalgia
- •Extensive surgery planned (surrogate for post-operative [postop] pain): Planned intensive care unit (ICU) admission, abdominoperineal resection, exenteration, use of intraoperative radiation (IORT), hyperthermic intraperitoneal chemotherapy (HIPEC)
- •Contraindication to neuraxial analgesia:
- •Coagulopathy
- •International normalized ratio (INR) > 1.2 current or predicted after surgery (e.g. planned right hepatic resection)
- •Thrombocytopenia. Platelets (plts) < 100
- •Hemophiliac disease states (hemophilia, von Willebrand disease, etc.)
- •Patients receiving antithrombotic or thrombolytic therapy are excluded according to the American Society of Regional Anesthesia and Pain Medicine (ASRA) guidelines
- •Localized infection at the potential site of injection
- •Significant developmental or structural spinal abnormalities that would preclude a safe spinal technique. These include spina bifida, tethered spinal cord, lumbar spinal fusion, and active lumbar radiculopathy
- •Patients with stage 4 or 5 kidney disease (glomerular filtration rate [GFR] less than 30 ml/min per 1.73 m^2)
- •Intolerance or allergy to opioids, acetaminophen, or amide-type local anesthetics
- •Current pregnancy
研究组 & 干预措施
Arm I (laparotomy, liposomal bupivacaine)
Patients undergo standard of care laparotomy and then receive liposomal bupivacaine.
干预措施: Laparotomy (Procedure)
Arm I (laparotomy, liposomal bupivacaine)
Patients undergo standard of care laparotomy and then receive liposomal bupivacaine.
干预措施: Liposomal Bupivacaine (Drug)
Arm I (laparotomy, liposomal bupivacaine)
Patients undergo standard of care laparotomy and then receive liposomal bupivacaine.
干预措施: Questionnaire Administration (Other)
Arm II (laparotomy, liposomal bupivacaine, hydromorphone)
Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT.
干预措施: Hydromorphone (Drug)
Arm II (laparotomy, liposomal bupivacaine, hydromorphone)
Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT.
干预措施: Laparotomy (Procedure)
Arm II (laparotomy, liposomal bupivacaine, hydromorphone)
Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT.
干预措施: Liposomal Bupivacaine (Drug)
Arm II (laparotomy, liposomal bupivacaine, hydromorphone)
Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Overall Benefit of Analgesia Score (OBAS)
时间窗: Up to 24 hours after surgery
The Overall Benefit of Analgesia Score (OBAS) is a multi-dimensional survey that measures a patient's benefit from postoperative pain therapy. It assesses pain intensity, opioid-related adverse events, and patient satisfaction with analgesia. Each of 7 questions are scored on a scale from 0 to 4 where 0=minimal/not at all and 4=maximum/very much. The total score is a sum of the 7 item scores with question 7 scored as 4 minus the patient reported number. Total scores range from 0 to 28 with lower scores representing greater benefit from analgesic therapy. The median total OBAS score for each group is presented.
次要结局
- Length of Stay(Up to 1 week after surgery)
- Additional Fluid Requirement After 24 Hours of Surgery(Up to 24 hours after surgery)
- Weight Gain Following Surgery(Up to 24 hours after surgery)
- Total Cost of Care(Entire hospitalization, approximately 2-5 days)
- Incidence of Adverse Events(Up to 24 hours after surgery)
- Operating Room Time(Approximately 8 hours)
- Surgical Time(Approximately 8 hours)
- Pain Management(Whole hospitalization, approximately 2-5 days)
- Cumulative 24-hour Narcotic Consumption(Up to 24 hours after surgery)
- Post-operative Pain Scores(Up to 24 hours after surgery)
- Time to First Analgesic Request(Up to 24 hours after surgery)
- Use of Intravenous (IV) Patient-controlled Analgesia(Up to 24 hours after surgery)
- Use of Intravenous Rescue Opioids(Up to 24 hours after surgery)