Quantitative Observational Comparative Effectiveness of Quadratus Lumborum (QL) Block With Liposomal Bupivacaine (Exparel®) Versus Thoracic Epidural Analgesia in Patients Undergoing Laparoscopic Colectomy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Cumulative Opioid Consumption Over 48 Hours
研究概览
简要总结
The purpose of this study is to determine if using a different type of injection of local anesthestic (pain medicine) in between the muscle layers of the abdominal wall (called a quadratus lumborum block) will improve pain control and be easier to manage after surgery than the current standard of care epidural (spinal injection) pain relief for patients undergoing laparoscopy colectomy.
详细描述
Participants in this study will receive exparel via an abdominal muscle nerve block procedure immediately prior to their operation. Participants will be in this study for 96 hours following surgery, which is typically 3 days. During participation, the study staff will review participant's electronic health records for pain scores and pain medication needs.
Participants that receive the quadratus lumborum block, may experience improved pain control and/or reduced side effects compared to the epidural pain relief option, but it is not known yet whether this will be the case.
The most common risk is being sore in the flank where the block was placed. Other risks of the block rarely occur (less than .5-1%), these can include infection, allergy to the local anesthetic, bleeding, damage to the nerve, seizures, abnormal heart rhythms, and cardiac arrest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective, laparoscopic colonic resection by one of three surgeons: Drs. Thacker, Mantyh or Migaly. These surgeons perform this procedure in the same manner
- •Age 18-85 years
- •American Society of Anesthesiologists (ASA) Physical Class I-III
- •BMI 18-35 kg/m^2
排除标准
- •Inability to consent
- •Inability to speak English
- •Pregnancy
- •Emergency surgery
- •Contraindications to regional blockade: coagulopathy or bleeding diathesis, local infection, allergy to local anesthetics
- •Allergies/intolerances/contraindications to any of the multimodal agents (acetaminophen, gabapentin, ketorolac)
- •Daily opioid equivalent use of 30 mg of morphine or greater at time of consent
- •History of drug or alcohol abuse
- •Rheumatoid arthritis
- •Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion of the investigator, may interfere with the study assessments of compliance
研究组 & 干预措施
Quadratus lumborum block
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
干预措施: Exparel (Drug)
Thoracic epidural analgesia
Historical cohort that received thoracic epidural analgesia.
干预措施: Thoracic epidural analgesia (Other)
结局指标
主要结局
Cumulative Opioid Consumption Over 48 Hours
时间窗: From arrival to PACU to 48 hours post-operatively
Measured in morphine milligram equivalents.
次要结局
- Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11)(30 minutes after arrival to Post-Anesthesia Care Unit (PACU), and at 8 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours and 168 hours post Exparel administration)