Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivicaine) Versus Continuous Erector Spinae Plane Block Catheter in Patients Undergoing Video Assisted Thoracoscopic (VAT) Surgery; Single Center, Non Inferiority, Open Label, Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Numeric Rated Pain Scale at Rest 0-4 Hours Post-operative
研究概览
简要总结
The purpose of this research is to compare a single shot long acting local anesthetic to catheter infusion of local anesthetic in patients undergoing video assisted thoracoscopic (VAT) surgery.
详细描述
The purpose of this research is to compare Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine (a long acting local anesthetic) to Ropivacaine (0.5% bolus followed by 0.2% infusion of local anesthetic using a catheter) in patients undergoing video assisted thoracoscopic (VAT) surgery.
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
- •Subjects who are age > 18, undergoing video thoracoscopic surgery and following Guthrie Robert Packer Hospital's Enhanced Recovery After Surgery (ERAS) protocol for Thoracic Surgery.
排除标准
- •weight < 50 kg, pregnant subjects,
- •left ventricular ejection fraction < 30%,
- •history of drug or narcotic abuse,
- •history of allergic to amide local anesthetic,
- •presence of contraindication for erector spinae plane block (local skin infection, sepsis, severe coagulopathy)
- •unable to provide consent,
- •unable to use pain rating scales as demonstrated by verbal feedback
- •preoperative chronic pain on narcotics,
- •history of renal insufficiency ( Creatinine > 1.5 mg/dl),
- •preoperative mild liver impairment ( i.e. AST/ALT above 1.5 times the upper normal limit)
研究组 & 干预措施
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
干预措施: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine (Drug)
Continuous catheter infusion ropivacaine
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
干预措施: Ropivacaine (0.5% bolus followed by 0.2% infusion) (Drug)
结局指标
主要结局
Numeric Rated Pain Scale at Rest 0-4 Hours Post-operative
时间窗: 0-4 hours post operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Numeric Rated Pain Scale With Cough 4-8 Hours Post-operative
时间窗: 4-8 hours post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Numeric Rated Pain Scale at Rest 4-8 Hours Post-operative
时间窗: 4-8 hours post operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Numeric Rated Pain Scale at Rest 8-12 Hours Post-operative
时间窗: 8-12 hours post operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Numeric Rated Pain Scale at Rest 12-24 Hours Post-operative
时间窗: 12-24 hours post operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Numeric Rated Pain Scale 48-72 Hours Post-operative
时间窗: 3 days post-operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Numeric Rated Pain Scale at Rest 24-48 Hours Post-operative
时间窗: 2 days post operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Numeric Rated Pain Scale With Cough 0-4 Hours Post-operative
时间窗: 0-4 hours post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Numeric Rated Pain Scale With Cough 8-12 Hours Post-operative
时间窗: 8-12 hours post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Numeric Rated Pain Scale With Cough 12-24 Hours Post-operative
时间窗: 12-24 hours post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Numeric Rated Pain Scale With Cough 24-48 Hours Post-operative
时间窗: 24-48 hours post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Numeric Rated Pain Scale With Cough 48-72 Hours Post-operative
时间窗: 48-72 hours post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
次要结局
- Total Intraoperative Opioid Consumption in Morphine Equivalent Dose(From start of surgery to end of surgery, an average of 2-3 hours)
- Acetaminophen Consumption in Milligrams 0-4 Hours Post-operative(0-4 hours post-operative)
- Acetaminophen Consumption in Milligrams 24-48 Hours Post-operative(24-48 hours post-operative)
- Gabapentin Consumption in Milligrams 0-4 Hours Post-operative(0-4 hours post-operative)
- Opioid Consumption in Morphine Equivalent Dose 4-8 Hours Post-operative(4-8 hours post-operative)
- Opioid Consumption in Morphine Equivalent Dose 16-24 Hours Post-operative(16-24 hours post-operative)
- Opioid Consumption in Morphine Equivalent Dose 24-48 Hours Post-operative(24-48 hours post-operative)
- Opioid Consumption in Morphine Equivalent Dose 48-72 Hours Post-operative(48-72 hours post-operative)
- Opioid Consumption in Morphine Equivalent Dose 0-4 Hours Post-operative(0-4 hours post-operative)
- Acetaminophen Consumption in Milligrams 4-8 Hours Post-operative(4-8 hours post-operative)
- Acetaminophen Consumption in Milligrams 8-16 Hours Post-operative(8-16 hours post-operative)
- Acetaminophen Consumption in Milligrams 16-24 Hours Post-operative(16-24 hours post-operative)
- Gabapentin Consumption in Milligrams 4-8 Hours Post-operative(4-8 hours post-operative)
- Opioid Consumption in Morphine Equivalent Dose 8-16 Hours Post-operative(8-16 hours post-operative)
- Acetaminophen Consumption in Milligrams 48-72 Hours Post-operative(48-72 hours post-operative)
- Gabapentin Consumption in Milligrams 8-16 Hours Post-operative(8-16 hours post-operative)
- Gabapentin Consumption in Milligrams 16-24 Hours Post-operative(16-24 hours post-operative)
- Gabapentin Consumption in Milligrams 24-48 Hours Post-operative(24-48 hours post-operative)
- Gabapentin Consumption in Milligrams 48-72 Hours Post-operative(48-72 hours post-operative)
- Ketorolac Consumption in Milligrams 0-4 Hours Post-operative(0-4 hours post-operative)
- Ketorolac Consumption in Milligrams 4-8 Hours Post-operative(4-8 hours post-operative)
- Ketorolac Consumption in Milligrams 8-16 Hours Post-operative(8-16 hours post-operative)
- Ketorolac Consumption in Milligrams 16-24 Hours Post-operative(16-24 hours post-operative)
- Ketorolac Consumption in Milligrams 24-48 Hours Post-operative(24-48 hours post-operative.)
- Ketorolac Consumption in Milligrams 48-72 Hours Post-operative(48-72 hours post-operative)
- Postoperative Quality of Recovery Score (QOR-15) 12-24 Hours Post-operative(12-24 hours post-operative)
- Postoperative Quality of Recovery Score (QOR-15) 24 to 48 Hours Post-operative(24-48 hours post-operative)
- Postoperative Quality of Recovery Score (QOR-15) 48 to 72 Hours Post-operative(48-72 hours post-operative)
- Post-operative Incentive Spirometry Changes From Preoperative Baseline at 0-4 Hours Post-operative(0-4 hours post-operative)
- Post-operative Incentive Spirometry Changes From Preoperative Baseline at 4-8 Hours Post-operative(4-8 hours post-operative)
- Post-operative Incentive Spirometry Changes From Preoperative Baseline at 8-12 Hours Post-operative(8-12 hours post-operative)
- Post-operative Incentive Spirometry Changes From Preoperative Baseline at 12-24 Hours Post-operative(12-24 hours post-operative)
- Post-operative Incentive Spirometry Changes From Preoperative Baseline at 24-48 Hours Post-operative(24-48 hours post-operative)
- Post-operative Incentive Spirometry Changes From Preoperative Baseline at 48-72 Hours Post-operative(48-72 hours post-operative)
- Length of Hospital Stay(From date of admission until date of discharge, an average of 72 hours)
研究者
Poovendran Saththasivam
Sponsor-Investigator
The Guthrie Clinic