Randomized, Unblinded, Phase III Trial of Thoracic Epidural Analgesia Versus Four-Quadrant Transversus Abdominus Plane Block in Oncologic Open-Incision Liver Surgery
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Total length of inpatient stay
研究概览
简要总结
This phase III trial studies how well thoracic epidural analgesia or four-quadrant transversus abdominus plane block works in reducing pain in patients undergoing liver surgery. It is not yet known whether thoracic epidural analgesia or four-quadrant transversus abdominus plane block may help people to recover more completely and more quickly after surgery.
详细描述
PRIMARY OBJECTIVE:
I. To compare length of hospital stay between patients treated with thoracic epidural analgesia (TEA) versus (vs.) pre-incision ultrasound-guided, four-quadrant transversus abdominus plane (TAP) block after open liver resection within an enhanced recovery program.
SECONDARY OBJECTIVES:
I. To compare the area under the curve of early (0-48 hour) post-operative pain scores and number of patients who experience severe postoperative pain between the TEA and TAP groups.
II. To compare anesthetic-related complication rates and need to change modalities between TEA and TAP groups.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing open liver resection without bowel resection/anastomosis for malignancy at MD Anderson Cancer Center
- •Patients must sign a study-specific consent form
- •Platelets >= 100,000/ml (within 30 days of surgery)
- •International normalized ratio (INR) =< 1.5 (within 30 days of surgery)
- •Activated partial thromboplastin time (aPTT) =< 40 (within 30 days of surgery)
- •Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude epidural placement
排除标准
- •Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver surgery
- •History of chronic narcotic use, defined as 30 days or more of preoperative daily narcotic use, measured from the date of surgery
- •Anaphylaxis to local anesthetics or narcotics
- •Previous or current neurologic disease affecting the lower hemithorax or below
- •Major open abdominal/thoracic surgery in the previous 30 days under general anesthesia
- •Technical contraindications to epidural placement: previous thoracic spinal surgery or local skin or soft tissue infection at proposed site for epidural insertion
- •Use of therapeutic anticoagulation within 5 days of surgery (not including venous thromboembolism prophylaxis)
- •Known bleeding diathesis or coagulopathy
- •Psychiatric (untreated or poorly controlled schizophrenia, major depression, or bipolar disorder), or communication (language) barrier that would preclude accurate assessment of postoperative pain and/or ability to answer questionnaires (need to be able to read, comprehend, and answer questions)
- •Inability to comply with study and/or follow-up procedures
- •Patient refusal to participate in randomization
- •Pregnant women are excluded from this study; women of childbearing potential (defined as those who have not undergone defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 12 consecutive months) must agree to practice adequate contraception and to refrain from breast-feeding, as specified in the informed consent
- •Patients with obvious unresectable disease prior to signing informed consent
- •Patients with previous ventral hernia repair, cosmetic abdominoplasty or anterior abdominal wall reconstruction
研究组 & 干预措施
Arm I (TAE)
Patients undergo placement of thoracic epidural catheter before surgery. Patients receive hydromorphone hydrochloride and bupivacaine via thoracic epidural catheter every 10 minutes or 3 hours as needed. Patients may receive fentanyl and bupivacaine or plain bupivacaine via thoracic epidural catheter.
干预措施: Fentanyl (Drug)
Arm I (TAE)
Patients undergo placement of thoracic epidural catheter before surgery. Patients receive hydromorphone hydrochloride and bupivacaine via thoracic epidural catheter every 10 minutes or 3 hours as needed. Patients may receive fentanyl and bupivacaine or plain bupivacaine via thoracic epidural catheter.
干预措施: Questionnaire (Behavioral)
Arm II (TAP)
Patients undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block. Patients receive plain bupivacaine and liposomal bupivacaine via TAP block.
干预措施: Implanted Medical Device (Device)
Arm II (TAP)
Patients undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block. Patients receive plain bupivacaine and liposomal bupivacaine via TAP block.
干预措施: Bupivacaine (Drug)
Arm I (TAE)
Patients undergo placement of thoracic epidural catheter before surgery. Patients receive hydromorphone hydrochloride and bupivacaine via thoracic epidural catheter every 10 minutes or 3 hours as needed. Patients may receive fentanyl and bupivacaine or plain bupivacaine via thoracic epidural catheter.
干预措施: Implanted Medical Device (Device)
Arm II (TAP)
Patients undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block. Patients receive plain bupivacaine and liposomal bupivacaine via TAP block.
干预措施: Questionnaire (Behavioral)
Arm I (TAE)
Patients undergo placement of thoracic epidural catheter before surgery. Patients receive hydromorphone hydrochloride and bupivacaine via thoracic epidural catheter every 10 minutes or 3 hours as needed. Patients may receive fentanyl and bupivacaine or plain bupivacaine via thoracic epidural catheter.
干预措施: Hydromorphone Hydrochloride (Drug)
Arm II (TAP)
Patients undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block. Patients receive plain bupivacaine and liposomal bupivacaine via TAP block.
干预措施: Liposomal Bupivacaine (Drug)
Arm I (TAE)
Patients undergo placement of thoracic epidural catheter before surgery. Patients receive hydromorphone hydrochloride and bupivacaine via thoracic epidural catheter every 10 minutes or 3 hours as needed. Patients may receive fentanyl and bupivacaine or plain bupivacaine via thoracic epidural catheter.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Total length of inpatient stay
时间窗: Up to 5 years
Will be recorded and compared between groups. Will be summarized using descriptive statistics including mean, standard deviation, median and range. Will be compared with 2-sample t- tests, Mann Whitney U tests or Wilcoxon rank sum tests as indicated.
次要结局
- Early post-operative pain control(Within 48 hours post surgery)
- Complication rates secondary to the analgesic regimen(Up to 5 years)
- Measures of functional recovery(Up to 5 years)
- Surgical complication rates(Up to 5 years)