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临床试验/NCT03581539
NCT03581539已完成不适用

Randomized, Prospective, Study Comparing Four-quadrant Transverses Abdominis Plane (TAP) Block, Quadratus Lumborum (QL) Block and Surgeon Infiltration Using Exparel for Postoperative Analgesia After Laparoscopic Nephrectomy

Indiana University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Primary endpoint of this study will be VAS pain score at 24 hours

研究概览

简要总结

All three methods of postoperative analgesia have been shown to decrease postoperative pain control in nephrectomy patients, the three methods have never been compared to each other.

This study aims to compare three different pain techniques proven to be beneficial in surgical nephrectomies, including the efficacy and the side effects of each technique.

详细描述

Both four-quadrant TAP block and QL blocks will be done after induction of anesthesia but prior to incision. Surgeon infiltration will be completed intraoperatively at the end of the surgery. All procedures will be done using sterile technique with masks, hats, and sterile gloves. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service.

All patients will receive 1 gm acetaminophen and 600 mg gabapentin preoperatively per SOC. Patients above 70 years will receive 300 mg gabapentin per SOC. Patients will be grouped by type of nephrectomy: simple, radical, or partial. Patients will be randomized to type of block. Intraoperatively, the patient will receive ketamine 0.5 mg/kg LBM at the beginning of the case followed by a 0.25 mg/kg/hr infusion during surgery but turned off prior to emergence per SOC; patients with relative contraindications to ketamine such as history of seizures may not receive ketamine and this will NOT be considered a deviation.

For group 1, the TAP block group, after the patient is induced, the skin will be prepped with ChloPrep and a clean, sterile transducer will be placed in an axial (transverse) plane to visualize the TAP plane just superior to the iliac crest. This will allow us to identify the three muscular layers of the abdominal wall: the external oblique (most superficial), the internal oblique, and the transversus abdominis. Using an in-plane technique (seeing the needle at all times), the needle will be advanced into the fascial plane between the internal oblique and transversus abdominis muscles under ultrasound guidance and 15 mL 0.125% bupivacaine plus 5 mL of Exparel® will be injected into the fascial plane; this procedure will be repeated in the other four quadrants of the abdomen. The tip of the needle will be observed under ultrasound at all times, making this a minimal risk procedure. It is also important to note that the mg dose of bupivacaine with exparel will never be in a ratio greater than 1:2 per Exparel dosing guidelines. A total of 80 mL will be given.

The QL block will be performed after induction with the patient placed in a slight lateral position in order to facilitate visualization of the Quadratus Lumborum muscle. Once the skin has been prepped and the sterile transducer is applied, the continuation of the transversalis fascia will be visualized along with the termination of the external and internal obliques. The quadratus lumborum will be identified deep to these structures. Once identified, an in plane technique will be used in order to place the needle in the plane just superior to the QL and 20 mL of 0.125% bupivacaine along with 10mL of Exparel will be injected. The same process will be repeated on the contralateral side. Once again the needle will be visualized throughout the procedure.

Surgeon infiltration will be completed at the end of the procedure before the patient emerges from general anesthesia. The needle will be inserted approximately 0.5 to 1 cm into the tissue plane to ensure that all layers of the surgical incision are infiltrated. The local anesthetic solution of 5 mL 0.125% bupivacaine plus 10 mL Exparel® will be injected while slowly withdrawing the needle to decrease the risk of intravascular injection.22 A total of 30 mL will be delivered. Surgeon name will be recorded.

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

入选标准

  • Patients undergoing laparoscopic nephrectomy including partial, simple and radical nephrectomy
  • ASA class 1, 2, 3 or 4
  • Age 18 or older, male or female

排除标准

  • Any contraindication for TAP block, QL block or surgeon infiltration
  • Donor Nephrectomy
  • History of substance abuse in the past 6 months
  • Patients on more than 30mg po morphine equivalents of opioids, staff anesthesiologist will confirm this portion prior to enrollment.
  • Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
  • Known allergy to bupivacaine or Exparel
  • Patients <40kg or >110 kg TBW

结局指标

主要结局

Primary endpoint of this study will be VAS pain score at 24 hours

时间窗: Pain scores will be measured 24 hours after surgery

The VAS scores will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

Primary endpoint of this study will be VAS pain score at 48 hours

时间窗: Pain scores will be measured 48 hours after surgery

Pain scores will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

次要结局

  • Secondary endpoint includes total IV and PO (By Mouth) opioid consumption at 72 hours(Opioid consumption will be measured at 1 hour post op, 24, 48, and 72 hours post op. The total amount will be recorded)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin Michael Backfish-White

Anesthesiologist

Indiana University

研究点 (2)

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