A Non-Inferiority Randomized Trial Comparing the Impact of Thoracic Epidural Analgesia Versus Surgical Site Infiltration With Liposomal Bupivicaine on the Postoperative Recovery of Patients Following Open Gynecologic Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Analgesia as assessed by pain intensity scores on a visual analog scale
研究概览
简要总结
The goal of this study is to test the hypothesis that surgical site infiltration with liposomal bupivacaine (LB) is non-inferior to and more cost effective than thoracic epidural analgesia (TEA) for patients undergoing open gynecologic surgery on an established enhanced recovery program (ERP) using a non-inferiority randomized trial design. The impact of TEA and surgical site infiltration with LB on neuroendocrine and inflammatory mediators of surgical stress response (SSR) will also be investigated as a translational endpoint.
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
- Female
- 接受健康志愿者
- 是
入选标准
- •Individuals ≥ 18 years of age
- •Planned laparotomy by the gynecologic oncology service at the sponsor institution.
排除标准
- •Individuals who have a contraindication to thoracic epidural analgesia
- •Individuals with a coagulation disorder
- •Individuals with an infection at the site of epidural placement
- •Individuals with intracranial pathology such as non-communicating increased intracranial pressure or obstruction of cerebrospinal fluid flow related to mass lesions
- •Individuals with spinal pathology: abnormal spine anatomy, surgical fusion, or spinal column lesions
- •Individuals who have a contraindication to liposomal bupivacaine
- •Individuals with a known allergic reaction to liposomal bupivacaine
- •Individuals with Childs-Pugh Class B or C liver disease
- •Individuals who have a history of long-term opioid use for chronic pain, defined as use of opioid pain medications for ≥4 weeks prior to surgery.
研究组 & 干预措施
Arm 1: Thoracic Epidural Analgesia with bupivicaine
Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance.
干预措施: Thoracic epidural analgesia (bupivacaine) (Other)
Arm 2: Surgical Site Infiltration with Liposomal Bupivacaine
Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons.
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Analgesia as assessed by pain intensity scores on a visual analog scale
时间窗: 0 to 48 hours postoperatively
Pain intensity will be measured using visual analog scale (VAS) pain intensity scores. The VAS scores pain intensity on a scale of 0-10, where 0 is no pain and 10 is the most severe pain.
Total opioid consumption
时间窗: 0 to 48 hours postoperatively
Total opioid consumption in IV mg morphine equivalents from 0 to 48 hours postoperatively will be compared between the two arms.
Analgesia Assessed by the Area Under the Curve of Visual Analog Scale Pain Intensity Scores
时间窗: 0 to 48 hours postoperatively
Pain intensity was measured using the Visual Analog Scale (VAS), a 0-10 scale where 0 indicates no pain and 10 indicates worst pain imaginable. VAS scores were assessed hourly from 0 to 48 hours postoperatively. The area under the curve (AUC) was calculated as the sum of hourly VAS scores over 48 hours, yielding a possible range of 0 to 480. Higher scores indicate greater cumulative pain burden and worse outcomes.
Total Opioid Consumption
时间窗: 0 to 48 hours postoperatively
Total opioid consumption in IV mg morphine equivalents from 0 to 48 hours postoperatively will be compared between the two arms.
次要结局
- Change in Total cortisol level (microgram/dL)(Baseline and postoperative day 7)
- Post-discharge narcotic utilization(Postoperative day 14)
- Change in Patient-perceived quality of recovery as assessed by the Quality of Recovery-15 instrument (QoR-15)(Days 1 through 7 post-intervention)
- Change in Serum adrenocorticotropic hormone (ACTH)(Baseline and postoperative day 7)
- Amount of Vasopressor required(Start of operation through hospital discharge, up to 1 year)
- Duration of Vasopressor administration(Start of operation through hospital discharge, up to 1 year)
- Change in Epinephrine level (pg/mL)(Baseline and postoperative day 7)
- Change in C-reactive protein level (ng/mL)(Baseline and postoperative day 7)
- Mobility as assessed by the Johns Hopkins Highest Level of Mobility (JH-HLM) scale(Up to 7 days post-intervention)
- Degree of sedation as assessed by the Pasero Opioid-Induced Sedation Scale(Up to 7 days post-intervention)
- Change in Anti-diuretic hormone (ADH) level(Baseline and postoperative day 7)
- Change in Glycosaminoglycans level (ng/mL)(Baseline and postoperative day 7)
- Change in Tumor necrosis factor alpha (TNF-α) level(Baseline and postoperative day 7)
- Change in Salivary cortisol (microgram/dL) level(Baseline and postoperative day 7)
- Total intravenous fluids administered in mL(Arrival in recovery through hospital discharge, up to 1 year)
- Change in Interleukin-6 level (pg/mL)(Baseline and postoperative day 7)
- Change in Atrial natriuretic peptide (ANP) level(Baseline and postoperative day 7)
- Time (days) to return of bowel function (ROBF)(Up to 7 days post-intervention)
- Number of participants with postoperative ileus(Up to 7 days post-intervention)
- Length of stay(Up to 1 year)
- Time to postoperative diuresis(Arrival in recovery through hospital discharge, up to 1 year)
- Number of postoperative complications(Day of admission through postoperative day 30)
- Total direct cost of TEA placement and LB surgical site infiltration(Up to 1 year)
- Change in Syndecan-1 level (pg/mL)(Baseline and postoperative day 7)
- Change in Endothelial glycocalyx constituents (ng/mL)(Baseline and postoperative day 7)
- Rate of 30-day hospital readmission(Up to 30 days post discharge from index admission)
- Mobility as Assessed by the Johns Hopkins Highest Level of Mobility (JH-HLM) Scale(Up to 7 days post-intervention)
- Patient-perceived Quality of Recovery as Assessed by the Quality of Recovery-15 Instrument (QoR-15)(Days 1 through 7 post-intervention)
- Time (Days) to Return of Bowel Function (ROBF)(Up to 7 days post-intervention)
- Number of Participants With Postoperative Ileus(Up to 7 days post-intervention)
- Number of Participants With Sedation Score ≥2 as Assessed by the Pasero Opioid-Induced Sedation Scale(Up to 7 days post-intervention)
- Length of Stay(Up to 1 year)
- Time to Postoperative Diuresis(Arrival in recovery through hospital discharge, up to 1 year)
- Total Intravenous Fluids Administered in mL(Arrival in recovery through hospital discharge, up to 1 year)
- Amount of Vasopressor Required(Start of operation through hospital discharge, up to 1 year)
- Duration of Vasopressor Administration(Start of operation through hospital discharge, up to 1 year)
- Number Participants With Postoperative Complications(Day of admission through postoperative day 30)
- Total Direct Cost of TEA Placement and LB Surgical Site Infiltration(Up to 1 year)
- Post-discharge Narcotic Utilization(Postoperative day 14)
- Number of Participants With 30-day Hospital Readmission(Up to 30 days post discharge from index admission)