Four Quadrants Transverse Abdominus Plane (4Q-TAP) Block With Plain and Liposomal Bupivacaine vs. Thoracic Epidermal Analgesia (TEA) in Patients Undergoing Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC) on an Enhanced Recovery Pathway: A Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Efficacy of TEA vs 4Q-TAP in QoR at Postoperative Day (POD)2
研究概览
简要总结
The goal of this clinical research study is to compare the effects of 4 quadrant TAP block (4Q-TAP block) with the standard-of-care thoracic epidural analgesia (TEA) in patients recovering from cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC).
A 4Q-TAP block is also known as an abdominal wall block and TEA is also known as a thoracic epidural. Both are types of anesthetics but are given in different ways. A 4Q-TAP block is when anesthetic injections are given in 4 different parts of the abdomen. A TEA is when an anesthetic injection is given in the space surrounding the spinal cord through your back.
This is an investigational study. The surgery and the levels of anesthetic participant is receiving are standard-of-care. It is investigational to compare 4Q-TAP block with TEA.
Up to 140 participants will be enrolled in this study. All will take part at MD Anderson.
详细描述
Baseline Tests:
If participant agrees to take part in this study, within 60 days before participant's surgery:
- Participant will have a physical exam.
- Blood (about 8 teaspoons) will be drawn for routine tests.
- Participant will complete a questionnaire about the quality of recovery. Participant's responses before surgery will be compared to participant's responses after surgery. It should take about 5 minutes to complete.
Study Groups/Procedures:
Participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups on the morning of participant's surgery. This is done because no one knows if one study group is better, the same, or worse than the other group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed consent
- •18 years old or older
- •American Society of Anesthesiologists physical status (ASA) 1-3
- •Scheduled surgery: open elective CRS-HIPEC
- •Able to complete the QoR 15 questionnaire
- •Patients scheduled to receive intraoperative chemotherapy
排除标准
- •Thrombocytopenia (platelet count: <100,000 cell/dL), coagulopathy (International Normalized Ratio > 1.5, PT>16.5 seconds or aPTT > 35.9 seconds)
- •Bupivacaine or liposomal bupivacaine sensitive or known allergy;
- •Pregnancy or breastfeeding patients
- •Patients with recent (within 60 days preoperatively) history severe hepatic disease (defined as liver injury with encephalopathy plus impaired synthetic liver function (i.e. >1.5)
- •Patients with recent (within 15 days preoperatively) history deteriorate kidney function (creatinine serum concentrations > 2.5 mg/dL or eGFR < 30 mL/kg/min)
- •Chronic opioid use defined as daily opioid use for more than one month prior the scheduled date of surgery
研究组 & 干预措施
Standard-of-Care Thoracic Epidural Analgesia (TEA)
An epidural catheter placed before induction of anesthesia by an anesthesiologist. A bolus or infusion of the local anesthetic solution with or without the addition opioids given before surgical incision according to anesthesia provider's clinical judgment.
干预措施: Local Anesthetic Solution (Drug)
4Q-TAP Blocks
Participants have an ultrasound guided 4Q-TAP block. A maximum of 80 cc of a solution consisting of 30 mg of bupivacaine HCl in 10 cc of preservative free normal saline (PFNS) and 65 mg of liposomal bupivacaine in 10 cc of PFNS injected before surgical incision in each of the four quadrants.
干预措施: Bupivacaine HCl (Drug)
4Q-TAP Blocks
Participants have an ultrasound guided 4Q-TAP block. A maximum of 80 cc of a solution consisting of 30 mg of bupivacaine HCl in 10 cc of preservative free normal saline (PFNS) and 65 mg of liposomal bupivacaine in 10 cc of PFNS injected before surgical incision in each of the four quadrants.
干预措施: Liposomal Bupivacaine (Drug)
结局指标
主要结局
Efficacy of TEA vs 4Q-TAP in QoR at Postoperative Day (POD)2
时间窗: 48 hours after CRS-HIPEC surgery
To compare the efficacy of 4 quadrants TAP blocks (4Q-TAP) versus Thoracic Epidural Analgesia (routine care) on the quality of recovery 48 hours after CRS-HIPEC surgery, measure by QoR-15 changes from Pre-Op to POD2. The QoR scale is a validated scoring system that allows for the quantification of a patient's early postoperative health status. The minimum score 0 and maximum score 150. The higher score mean a better outcome.
次要结局
- Number of Participants With Adverse Events Related to 4Q-TAP Versus TEA(48 hours after CRS-HIPEC surgery)
- Comparison of the Length of Stay (LOS) Between Patients With 4Q-TAP Versus TEA(Length of stay calculated from day of surgery to date of hospital discharge, up to 46 days)
- 4Q-TAP Versus TEA on Postoperative Pain(48 hours after CRS-HIPEC surgery)
- Comparison of the Total Opioid Consumption Between Patients With 4Q-TAP Versus TEA(During the 48 hours after CRS-HIPEC surgery)
- Number of Participants With Incidence of Opioid-Related Adverse Events Related to 4Q-TAP Versus TEA 48(Within the first 48 hours after the end of CRS-HIPEC surgery)
- Number of Participants With Incidence of Postoperative Complications and Morbidity in Patients Receiving 4Q-TAP Versus TEA(48 hours after CRS-HIPEC surgery)