QL Block With Exparel in Colectomy
关键词
抽象
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.
日期
| 最后验证: | 06/30/2020 |
| 首次提交: | 01/30/2019 |
| 提交的预估入学人数: | 01/30/2019 |
| 首次发布: | 01/31/2019 |
| 上次提交的更新: | 07/09/2020 |
| 最近更新发布: | 07/13/2020 |
| 实际学习开始日期: | 10/30/2019 |
| 预计主要完成日期: | 03/31/2021 |
| 预计完成日期: | 04/07/2021 |
状况或疾病
干预/治疗
Drug: Quadratus lumborum block
Other: Thoracic epidural analgesia
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: 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. | Drug: 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. |
| Other: Thoracic epidural analgesia Historical cohort that received thoracic epidural analgesia. | Other: Thoracic epidural analgesia Historical cohort that received thoracic epidural analgesia |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
结果
主要结果指标
1. Cumulative opioid consumption over 48 hours [Opioid consumption from administration of Exparel to 48 hours post-administration]
其他成果措施
1. 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]
2. Block success [30 minutes after arrival to PACU, 8 hours, 24 hours, 36 hours, 48 hours and 72 hours post Exparel administration]
3. Adverse Events [From administration of Exparel through 168 hours post Exparel administration]
4. Satisfaction with postoperative pain control [From administration of Exparel through 48 hours post Exparel administration]
5. Hospital length of stay [From administration of Exparel through hospital discharge]
6. Incidence of opioid-related adverse events [From administration of Exparel through 168 hours post Exparel administration]
7. Time to first mobilization [From time of arrival in PACU through first mobilization]
8. Cost [From time of arrival in PACU through 96 hours post Exparel administration]
9. Sleep Quality [From administration of Exparel through 168 hours post Exparel administration]
