Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The difference in discharge opioid consumption in morphine milligram equivalents (MMEs)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
The study participants, surgeons and PACU nurses will be blinded.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients from 18-90 years old who are undergoing laparoscopic hiatal hernia surgery
- •Elective Laparoscopic hiatal hernia repair
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Opioid Based Anesthesia Protocol (OBA) (Other)
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.
干预措施: Opioid Sparing Anesthesia Protocol (OSA) (Other)
结局指标
主要结局
The difference in discharge opioid consumption in morphine milligram equivalents (MMEs)
时间窗: through postoperative Day 7
The difference in discharge opioid consumption in morphine milligram equivalents (MMEs) through postoperative day 7 in patients in the Opioid Sparing Anesthesia (OSA) protocol vs. Opioid Based Anesthesia (OBA) protocol will be collected.
The Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)
时间窗: Postoperative day 1,2, 3, 4, 5, 6 and 7.
The difference in discharge opioid consumption in morphine milligram equivalents (MMEs) from postoperative day 1 through postoperative day 7 in patients in the Opioid Sparing Anesthesia (OSA) protocol vs. Opioid Based Anesthesia (OBA) protocol will be collected.
次要结局
- Postoperative Visual Analogue Scale (VAS) pain scores(Upon post-anesthesia care unit arrival (within 2 hours after surgery), upon post-anesthesia care unit discharge (4 hours after surgery), and upon hospital discharge (up to 7 days))
- Total Hospital Opioid Consumption (MMEs)(up to 7 days)
- Post Anesthesia Care Unit(up to 7 days)
- Rate of emergency room visit(within 30 days)
- Hospital Length of stay(up to 7 days)
- Incidence of post operative nausea and vomiting (PONV )(during post anesthesia care unit stay (up to 3 hours), postoperative Day 1, during hospital stay (up to 7 days))
- Rate of rehospitalization(within 30 days)
- Rate of reoperation(within 30 days)
- Surgeon satisfaction with surgical conditions(within 30 minutes after surgery)
- Hospital Cost Differential(up to 30 days)
- Rate of Rehospitalization(within 30 days of surgery)
- Postoperative Visual Analogue Scale (VAS) Pain Scores(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)(From PACU admission until hospital discharge, up to 7 days after admission)
- Post Anesthesia Care Unit(from PACU admission until PACU discharge)
- Hospital Length of Stay(from hospital admission for hernia surgery until hospital discharge)
- Incidence of Post Operative Nausea and Vomiting (PONV )(during post anesthesia care unit stay (up to 3 hours), postoperative Day 1, during hospital stay (up to 7 days))
- Rate of Reoperation(within 30 days of surgery)
- Rate of Emergency Room Visit(within 30 days of surgery)
- Surgeon Satisfaction With Surgical Conditions(within 30 minutes after surgery)
- VAS Pain Severity Postoperative Days 1-7(Postoperative days 1, 2, 3, 4, 5, 6, 7.)
- Total Ketorolac Dose(From hospital admission until hospital discharge)
研究者
Steven Greenberg
Jeffery S. Vender Endowed Chair of Anesthesiology Research and Education
Endeavor Health