Effect of Laparoscopic-Guided Transversus Abdominus Plane (TAP) Block on Opioid Consumption Using Dual-Adjunct Therapy With Dexmedetomidine and Dexamethasone Versus Liposomal Bupivacaine (Exparel®) Following Minimally Invasive Colorectal Surgery: A Single-Blinded Randomized Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Visual analog scale pain scores 12 hours post op
研究概览
简要总结
Study the effect of laparoscopic guided TAP block on opioid consumption and associated costs using a mixture of dexmedetomidine, dexamethasone, and ropivacaine versus Liposomal bupivacaine (Exparel®) in patients who undergo elective minimally invasive colorectal surgery.
详细描述
This is a non-inferiority single-blinded randomized trial aiming to study the effect of laparoscopic guided TAP block on opioid consumption and associated costs using a mixture of dexmedetomidine, dexamethasone, and ropivacaine versus Liposomal bupivacaine (Exparel®) in patients who undergo elective minimally invasive colorectal surgery. This study aims to continue improving our current hospital wide effort in reducing opioid consumption and, consequently, the acute and long-term consequences of opioids. It will also complement the current ongoing efforts of the Department of Surgery's quality and safety improvement project in opioid stewardship. Additionally, this dual adjunct TAP solution combination is inexpensive ($28 per injection) and may result in a significant cost savings for the hospital.
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
- Single (Participant)
盲法说明
This study is a randomized single blinded trial to minimize bias and provide highest level of evidence in use as part of effort to reduce opioid use consumption. This study cannot be performed as a double blinded RCT due to Exparel being milky white color in appearance and cannot be altered or shielded from being visible by the operating surgeon performing the TAP block.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •provision to sign and date the consent form.
- •stated willingness to comply with all study procedures and be available for the duration of the study.
- •Male and female patients aged 18 and older
- •Benign or malignant colorectal disease undergoing laparoscopic, robotic, or a "hybrid" (minimally invasive dissection with a 6-8 cm incision to complete the surgery) colorectal resection with or without an ostomy
排除标准
- •Pregnant or breastfeeding patients
- •Medical conditions that may interfere with the use of the study medications (e.g., drug allergy),
- •Patients with opioid dependence defined as chronic opioid use more than 3 times per week preoperatively
- •Incarcerated individuals
- •Age less than 18 years-old
- •Urgent/emergent operations as defined by need for operation within 24 hours
- •Other conditions or general disability or infirmity that in the opinion of the investigator precludes further participation in the study.
- •Enrollment in another concurrent study with use of investigational drugs
研究组 & 干预措施
Investigational Arm
The study drug volume, concentration, and dose of treatment arm #1 selected is based on the Principal Investigator's prior experience recommendations by the Food Drug Administration (FDA), and evidence based on prior literature. The final concentration of ropivacaine is 0.375% and final volume of the mixture is 60mL.
- Ropivacaine 0.5% HCl, 40 mL (5 mg per mL) (200 mg)
- Dexmedetomidine HCl, 0.50 ml (100 ug per mL) (50 ug)
- Dexamethasone sodium phosphate, 1 mL (10 mg per mL) (10 mg)
- Normal saline 0.9%, 18.5mL
干预措施: Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline (Combination Product)
Liposomal Bupivacaine (Exparel)
The study drug for patients in the treatment arm #2 will be a mixture of liposomal bupivacaine and bupivacaine 0.25% as follows:
- Liposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg)
- Normal saline 0.9%, 40mL The total volume to be injected in each patient will be 60 mL (see below for different treatment arms).
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Visual analog scale pain scores 12 hours post op
时间窗: 12 hours
Visual analog scale pain scores 12 hours post op
Prescribed opioid at discharge
时间窗: 2 months
Amount of opioid prescribed at discharge
Visual analog scale pain scores 72 hours post op
时间窗: 72 hours
Visual analog scale pain scores 72 hours post op
Outpatient narcotic refill
时间窗: 2 months
Use the EMR to determine outpatient narcotic refill
Post-operative opioid consumption in the first 72 hours
时间窗: 72 hours
Total amount of both intravenous and oral opioid use in the first 72 hours after surgery measured in morphine milligram equivalents.
Visual analog scale pain scores 24 hours post op
时间窗: 24 hours
Visual analog scale pain scores 24 hours post op
Visual analog scale pain scores 48 hours post op
时间窗: 48 hours
Visual analog scale pain scores 48 hours post op
Epidural need
时间窗: 2 months
Need for an epidural post-operatively. Reviewed using the EMR.
Need for adjunctive systemic nonopioid pain medications
时间窗: 2 months
Adjunctive systemic nonopioid pain medications
Need for postoperative patient-controlled analgesia (PCA)
时间窗: 72 hours
Determined by review of EMR. Patients use or non-use of PCA.
Post-operative opioid consumption over hospital stay
时间窗: 2 months
Total morphine dose equivalents administered throughout hospital stay
Visual analog scale pain scores in the PACU
时间窗: 72 hours
Visual analog scale (VAS) pain scores in the PACU
Visual analog scale pain scores 36 hours post op
时间窗: 36 hours
Visual analog scale pain scores 36 hours post op
次要结局
- Use of antiemetics in the first 24 hours post op(24 hours)
- Use of antiemetics in the first 48 hours post op(48 hours)
- Need to insert nasogastric tube(2 months)
- Length of hospital stay(2 months)
- Use of antiemetics in the first 36 hours post op(36 hours)
- Use of antiemetics in the first 72 hours post op(72 hours)
- Time to first flatus(2 months)
- Use of antiemetics in the first 12 hours post op(12 hours)
- Time to first bowel movement(2 months)