Randomized Prospective Study Comparison of Erector Spinae Plane Block and Intrathecal Opioid for Postoperative Analgesia After Laparoscopic Colorectal Surgery in an Enhanced Recovery Setting
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- 24 Hour Cumulated Oral Morphine Equivalent (OME)
研究概览
简要总结
This study is being done to compare 2 types of pain control methods and determine which is more effective postoperatively for laparoscopic colorectal surgery. Group 1 will receive an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid. Group 2 will receive an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
详细描述
All laparoscopic colorectal cases were scheduled by colorectal surgeons at IU Health University or Methodist Hospital and were identified using medical records. The subjects were contacted face-to-face prior to surgery. They were informed about the study and questions were answered. The potential subjects were given a copy of the informed consent form and authorization form. The subjects were contacted face-to-face in Pre-Operative Care Unit on the day of surgery and if they decided to participate, written consent was taken.
In the Intrathecal group, intrathecal preservative free morphine (duramorph) 200 mcg with 7.5mg of hyperbaric bupivacaine was given for a patient 18-75 years of age and duramorph 150 mcg with 7.5mg of hyperbaric bupivacaine was given for a patient 76- 80 years of age.
In the ESP group, a patient was given a bilateral ESP block at thoracic vertebrae level 10 (T10). This was placed under ultrasound using 30 ml of 0.25% bupivacaine and 4 mg of Decadron.
Randomization will be performed using Research Randomizer. The primary investigator informed the person doing the regional techniques as to what group the patients were randomized to. Neither the patients and the research staff doing assessments will be blinded to the randomization.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital
- •ASA Class 1, 2, 3 (American Society of Anesthesiologists physical status classification system)
- •Age 18 to 80 years (male or female)
- •BMI < 40kg/m2
- •Desires regional anesthesia for postoperative pain control
排除标准
- •Any contraindication for neuraxial analgesia or ESP block procedure
- •Contraindications for neuraxial analgesia include: Elevated intracranial pressure (except in cases of pseudo-tumor cerebri), infection at the site of injection, lack of consent from the patient, patient refusal, true allergy to any drug used in the spine, and uncorrected hypovolemia.
- •Contraindications for ESP block procedure include: Infection at the site of injection, patient refusal, true allergy to any of the drugs used in the block, and lack of patient consent.
- •Any patient undergoing a laparoscopic abdominoperineal resection.
- •Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
- •Known true allergy to the study medications (morphine, bupivacaine, decadron, Tylenol, Celebrex)
- •Takes over 30 mg of oral morphine equivalents daily
- •Any history of substance abuse in the past 6 months
- •End stage liver disease, end stage renal disease
- •Body weight of < 50 kg
研究组 & 干预措施
ESP Block
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
干预措施: ESP Block (Drug)
IT Injection
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
干预措施: IT Injection (Drug)
结局指标
主要结局
24 Hour Cumulated Oral Morphine Equivalent (OME)
时间窗: 24 hours after surgery
24 hour cumulated oral morphine consumption (OME)
次要结局
- First Flatus(Duration of hospital stay up to 72 hours)
- Oral Liquid(Duration of hospital stay up to 72 hours)
- Oral Food(Duration of hospital stay up to 72 hours)
- Oral Morphine Equivalents (OME)(72 hours after surgery)
- Oral Morphine Equivalents (OME)(1 hour after surgery)
- Oral Morphine Equivalents (OME)(12 hours after surgery)
- Oral Morphine Equivalents (OME)(24 hours after surgery)
- Oral Morphine Equivalents (OME)(48 hours after surgery)
- Visual Analog Scale Pain Scores(1 hour after surgery)
- Visual Analog Scale Pain Scores(12 hours after surgery)
- Visual Analog Scale Pain Scores(24 hours after surgery)
- Visual Analog Scale Pain Scores(48 hours after surgery)
- Visual Analog Scale Pain Scores(72 hours after surgery)
- First Ambulation(Duration of hospital stay up to 72 hours)
- Hospital Length of Stay(Duration of hospital stay up to 7 days)
- Patient's Satisfaction Scores(24 hours after surgery)
- Patient's Satisfaction Scores(48 hours after surgery)
- Number of Participants With Side Effects(Duration of hospital stay up to 72 hours)
- Nausea(Duration of hospital stay up to 72 hours)
研究者
Amy McCutchan
Assistant Professor of Clinical Anesthesiology
Indiana University