减少腹腔镜食管裂孔疝患者术后阿片类药物的使用
This is a prospective randomized, double-blinded, controlled trial that will target enrollment of 46 subjects undergoing laparoscopic hiatal hernia repair surgery. Participants who meet eligibility criteria will be randomized in a 1:1 ratio to receive either the opioid sparring anesthesia protocol (OSA) or the opioid based anesthesia protocol (OBA). The purpose of this study is to investigate if an opioid sparring protocol for laparoscopic hiatal hernia repair will reduce opioid consumption during discharge. Other outcomes include: postoperative VAS scores (PACU arrival, PACU discharge, hospital discharge), total in hospital opioid consumption, PACU length of stay, incidence of postoperative nausea and vomiting (PONV in PACU, postoperative day 1, during hospital stay), rehospitalization rate, rate of reoperation, rate of emergency room visit, surgeon satisfaction, and hospital cost differential.
研究概览
地位
条件
详细说明
The administration of perioperative opioids to nearly 80% of surgical patients leaves approximately 6 million Americans susceptible to becoming opioid-dependent. This practice has been hypothesized as a contributing factor to the ongoing opioid crisis, where currently more than 136 Americans die from an opioid overdose every day. Recent data suggest a potential benefit of reducing perioperative opioid use, while improving the quality of surgical recovery when employing an Opioid Sparing Anesthesia (OSA) protocol with non-narcotic analgesics.
More than a million hernia repairs are performed each year in the US. With the significant nationwide obesity epidemic, it is estimated that the prevalence of hiatal hernias in the western population is approximately 20%. The investigators perform hundreds of laparoscopic hiatal hernia repairs annually at NorthShore University HealthSystem. Patients routinely receive fentanyl and other opioids during this surgery to reduce pain, but opioids also increase the risk of nausea, vomiting, and ileus. In addition, these patients are often times prescribed opioids upon discharge from the hospital. Preliminary results from a small, retrospective study among laparoscopic hiatal hernia surgical patients suggested that an OSA protocol with non-narcotic analgesics (that included dexmedetomidine and ketamine) resulted in a 33% reduction in those patients requiring opioids post-discharge. Moreover, these same patients had a significant reduction in hospital length of stay and nausea/retching. Therefore, the investigators propose a double-blinded randomized controlled trial to compare the number of patients in OSA protocol vs. Opioid Based Anesthesia (OBA) protocol groups, who require no opioids within 7 days postoperatively, (a time period where our quality data suggest nearly all patients receive postoperative opioids in this population).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Illinois
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Evanston、Illinois、美国、60201
- Endeavor Health
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients from 18-90 years old who are undergoing laparoscopic hiatal hernia surgery
- Elective Laparoscopic hiatal hernia repair
Exclusion Criteria:
- Patients receiving urgent or emergent hiatal hernia surgery
- Patients receiving hiatal hernia surgery without laparoscopy
- Patients with adverse reactions (e.g., anaphylaxis, rash) to any of the drugs in the OBA or OSA protocols.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Opioid Sparing Anesthesia Protocol
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids. |
OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids. |
|
其他：Opioid Based Anesthesia Protocol
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case. |
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)
大体时间：From hospital discharge through postoperative day 7.
|
Cumulative outpatient oral opioid consumption, expressed in morphine milligram equivalents (MMEs), from hospital discharge through postoperative day 7 was compared between the Opioid Sparing Anesthesia (OSA) and Opioid Based Anesthesia (OBA) groups. |
From hospital discharge through postoperative day 7.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative Visual Analogue Scale (VAS) Pain Scores
大体时间：Upon post-anesthesia care unit (PACU) arrival (within 2 hours after surgery), upon PACU discharge (4 hours after surgery), at hospital discharge, and on postoperative day 1, 2, 3, 4, 5, 6, and 7.
|
Patients Visual Analogue Scale (VAS) pain scores in each group will be collected. Subjects will rate their pain level on a scale of 0-10 cm. Number "0" indicates no pain and number "10" indicates terrible pain. |
Upon post-anesthesia care unit (PACU) arrival (within 2 hours after surgery), upon PACU discharge (4 hours after surgery), at hospital discharge, and on postoperative day 1, 2, 3, 4, 5, 6, and 7.
|
|
Postoperative Hospital Opioid Consumption (MMEs)
大体时间：From PACU admission until hospital discharge, up to 7 days after admission
|
Total hospital opioid consumption (MMEs) in each group will be collected starting from the end of surgery (PACU admission) until hospital discharge or on postoperative day 7, whichever is first. |
From PACU admission until hospital discharge, up to 7 days after admission
|
|
Post Anesthesia Care Unit
大体时间：from PACU admission until PACU discharge
|
Post anesthesia care unit (PACU) length of stay (hours) in each group will be recorded. |
from PACU admission until PACU discharge
|
|
Hospital Length of Stay
大体时间：from hospital admission for hernia surgery until hospital discharge
|
Hospital length of stay (hours) in each group will be recorded. |
from hospital admission for hernia surgery until hospital discharge
|
|
Incidence of Post Operative Nausea and Vomiting (PONV )
大体时间：during post anesthesia care unit stay (up to 3 hours), postoperative Day 1, during hospital stay (up to 7 days)
|
Incidence of post operative nausea and vomiting in each group will be recorded. |
during post anesthesia care unit stay (up to 3 hours), postoperative Day 1, during hospital stay (up to 7 days)
|
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Rate of Rehospitalization
大体时间：within 30 days of surgery
|
Rate of rehospitalization will be recorded for each group up to 30 days after hiatal hernia surgery. |
within 30 days of surgery
|
|
Rate of Reoperation
大体时间：within 30 days of surgery
|
Rate of reoperation will be recorded for each group up to 30 days after hiatal hernia surgery. |
within 30 days of surgery
|
|
Rate of Emergency Room Visit
大体时间：within 30 days of surgery
|
Rate of emergency room visits will be recorded up to 30 days after hiatal hernia surgery. |
within 30 days of surgery
|
|
Surgeon Satisfaction With Surgical Conditions
大体时间：within 30 minutes after surgery
|
Surgeon satisfaction with surgical conditions using a 5-point Likert score will be collected after surgery. A scale from 1-5; 1=Very dissatisfied, 2=Somewhat dissatisfied, 3=Neutral, 4=Somewhat satisfied, 5=Very satisfied) |
within 30 minutes after surgery
|
|
VAS Pain Severity Postoperative Days 1-7
大体时间：Postoperative days 1, 2, 3, 4, 5, 6, 7.
|
VAS Pain Severity was calculated for Postoperative Days 1-7. VAS scores of 0-3 were classified as mild, scores of 4-6 were classified as moderate, and scores of 7-10 were classified as severe. |
Postoperative days 1, 2, 3, 4, 5, 6, 7.
|
|
Total Ketorolac Dose
大体时间：From hospital admission until hospital discharge
|
Total Ketorolac dose administered intraoperatively and postoperatively until hospital discharge |
From hospital admission until hospital discharge
|
合作者和调查者
调查人员
- 首席研究员：Steven Greenberg, MD、Endeavor Health
出版物和有用的链接
一般刊物
- Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.
- Wengritzky R, Mettho T, Myles PS, Burke J, Kakos A. Development and validation of a postoperative nausea and vomiting intensity scale. Br J Anaesth. 2010 Feb;104(2):158-66. doi: 10.1093/bja/aep370. Epub 2009 Dec 26.
- Lawal OD, Gold J, Murthy A, Ruchi R, Bavry E, Hume AL, Lewkowitz AK, Brothers T, Wen X. Rate and Risk Factors Associated With Prolonged Opioid Use After Surgery: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Jun 1;3(6):e207367. doi: 10.1001/jamanetworkopen.2020.7367.
- Bastawrous AL, Brockhaus KK, Chang MI, Milky G, Shih IF, Li Y, Cleary RK. A national database propensity score-matched comparison of minimally invasive and open colectomy for long-term opioid use. Surg Endosc. 2022 Jan;36(1):701-710. doi: 10.1007/s00464-021-08338-9. Epub 2021 Feb 10.
- Siu EY, Moon TS. Opioid-free and opioid-sparing anesthesia. Int Anesthesiol Clin. 2020 Spring;58(2):34-41. doi: 10.1097/AIA.0000000000000270. No abstract available.
- Hoffman C, Buddha M, Mai M, Sanjeevi S, Gutierrez R, O' Neill C, Miller A, Banki F. Opioid-Free Anesthesia and Same-Day Surgery Laparoscopic Hiatal Hernia Repair. J Am Coll Surg. 2022 Jul 1;235(1):86-98. doi: 10.1097/XCS.0000000000000229. Epub 2022 Apr 11.
- Anderson R, Saiers JH, Abram S, Schlicht C. Accuracy in equianalgesic dosing. conversion dilemmas. J Pain Symptom Manage. 2001 May;21(5):397-406. doi: 10.1016/s0885-3924(01)00271-8.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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