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临床试验/NCT03794882
NCT03794882终止4 期

Impact of Preoperative Quadratus Lumborum Block on Recovery Profile After Laparoscopic Ventral Hernia Repair

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年5月6日最近更新:
适应症

试验速览

阶段
4 期
状态
终止
入组人数
14
试验地点
2
主要终点
Postoperative Day (POD) 1 Pain Score

研究概览

简要总结

Ventral hernia repair may be associated with significant postoperative pain. Pain is typically managed with intravenous (IV) and oral medications that come with their own risks, such as nausea, constipation, sedation, respiratory depression, increased bleeding, and/or kidney or liver dysfunction. The quadratus lumborum peripheral nerve block has been shown to produce anesthesia of the anterior abdominal wall in the T7 to L1 distribution. This study aims to evaluate if the addition of the quadratus lumborum peripheral nerve block (QLB) can improve pain scores, decrease the need for IV and oral pain medications, and/or speed the patients' return to normal activity.

详细描述

Current trends in perioperative pain management stress the importance of multimodal analgesia in an effort to reduce the dependence on opioid pain medications. Adverse effects of opioids include sedation, respiratory depression, nausea, vomiting, constipation, itching, and, most importantly, the potential for tolerance and abuse. Multimodal analgesia attempts to utilize multiple techniques, including medications and nerve block procedures, to improve postoperative analgesia. Improved postoperative pain control can enable an earlier return to normal activities for patients, not only improving patient satisfaction, but also reducing postoperative morbidity and adverse effects of opioids.

Approximately 350,000 to 500,000 ventral hernia repairs are performed each year in the United States. Surgeries completed laparoscopically are typically performed on an outpatient basis, allowing patients to return home the same day of surgery and treat their pain independently with prescribed pain medications. Utilization of a regional anesthesia technique may allow prolonged numbing of the nerves postoperatively and decrease the reliance on oral pain medications. Transversus abdominis plane (TAP) blocks have been shown to decrease pain scores and opioid consumption following ventral hernia repair. Quadratus lumborum (QL) blocks are newer iterations of the TAP block.

There are currently three types of the QL block, all targeting the thoracolumbar fascia surrounding the quadratus lumborum muscle. Injection within this fascial plane may allow local anesthetic spread into the paravertebral space, possibly explaining why QL blocks have been mapped from the T7 to T12/L1 dermatomes, covering the entire abdomen. Conversely, TAP blocks have been mapped from the T10 to T12/L1 dermatomes, only covering the abdomen below the umbilicus. In the first, the Quadratus lumborum 1 block (QL1), the local anesthetic is injected within the fascial plane lateral to the QL muscle. In the second, the Quadratus lumborum 2 block (QL2), the needle trajectory is more superficial, and the local anesthetic is injected along the posterior border of the QL muscle. The third iteration, the Quadratus lumborum 3 block (QL3), involves a deeper, transmuscular approach with injection along the anterior border of the QL muscle. Our study would utilize the QL2 approach as the dermatomal distribution of the QL1 and QL2 blocks appear to be more widespread than the QL3 block, and the QL2 block may be a safer approach due to the more superficial angle of the needle 3.

Additionally, the QL block has been shown to have a longer duration of analgesia when directly compared to the TAP block. A study of pediatric lower abdominal surgery revealed improved pain scores and parent satisfaction with care in the QL group compared to TAP block. This improvement persisted to the 24 hour mark. In a study of postoperative pain following cesarean delivery, pain scores were improved and opioid consumption decreased with the QL block compared to the TAP block. The differences were not significant at the 1 and 6 hour marks, but were significant at the 12, 24 and 48 hour marks, highlighting the analgesic duration of the QL block 8.

This study aims to evaluate the efficacy of the QL block using the QL2 approach on recovery profile after laparoscopic ventral hernia repair, a commonly performed surgery, as well as contribute to the understanding of the block and its distribution of anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

The participant is blinded to the treatment.

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

入选标准

  • The subject is scheduled for elective laparoscopic ventral hernia repair;
  • The subject is ≥ 18 years and ≤ 80 years;
  • The patient agrees to receive a quadratus lumborum block
  • American Society of Anesthesiologists class 1-3.

排除标准

  • Subject is < 18 years of age or >80 years of age;
  • Subject is non-English speaking;
  • Subject is known or believed to be pregnant;
  • Subject is a prisoner;
  • Subject has impaired decision-making capacity per discretion of the Investigator;
  • Significant renal, cardiac or hepatic disease per discretion of the investigator;
  • American Society of Anesthesiologists class 4-5;
  • Known hypersensitivity and/or allergies to local anesthetics;
  • Chronic opioid use (daily or almost daily use of opioids for > 3 months at any point in their lives).
  • Repair of a recurrent ventral hernia
  • Repair of multiple ventral hernias
  • Unobtainable sonographic views
  • Lacking health insurance

结局指标

主要结局

Postoperative Day (POD) 1 Pain Score

时间窗: 24 hours

Pain Score assessed on POD 1 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.

次要结局

  • Pain Score at Rest(PACU, POD1, POD2, POD7)
  • Additional Analgesics in Milligrams Administered in the Operating Room(6 hours)
  • Numbness Distribution in PACU(12 hours)
  • Total Antiemetic Consumption on POD 0 and in PACU(12 hours)
  • Additional Analgesics in Milliliters Administered in the Operating Room(6 hours)
  • Pain Score With Activity(PACU, POD1, POD2, POD7)
  • Postoperative Time to Discharge(72 hours)
  • Number of Participants With Presence of Nausea Necessitating Treatment(POD1, POD2, POD7)
  • Rating of Satisfaction With Perioperative Care(POD1, POD2, POD7)
  • Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams(12 hours)
  • Opioid Consumption in Oral Morphine Milligram Equivalent (OMME)(PACU, POD1, POD2, POD7)
  • Location of Most Severe Pain(PACU, POD1, POD2, POD7)
  • Time in PACU(48 hours)
  • Number of Participants Who Report Nausea in PACU(12 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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