Opioid Based Analgesia vs Non-opioid Analgesia for Oocyte Retrieval Procedure - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the difference in average pain scores
研究概览
简要总结
It is unclear whether routine addition of opioids for analgesia during minor gynecological procedures is beneficial. In this single-center randomized single-blinded trial, the investigators aim to test the primary hypothesis that opioid-sparing anesthesia regimen including intravenous acetaminophen is non-inferior to a similar anesthesia regimen containing fentanyl in providing postoperative analgesia in women recovering from oocyte retrieval procedures for in vitro fertilization. The investigators also aim to assess the difference in incidence of patient-reported opioid related adverse-effects between the two groups, time to discharge from the post-anesthesia care unit and postoperative rescue analgesia requirements. If we demonstrate no clinically important difference between the two interventions, clinicians may be able to substantially reduce the amount of opioids administered to patients undergoing minor ambulatory procedures, and potentially decrease the associated opioid related adverse effects.
详细描述
Study Overview The investigators propose a single-center randomized single-blinded clinical trial in which healthy women undergoing oocyte retrieval procedures under general anesthesia will be randomized to receive either 1.5mcg/kg fentanyl or IV acetaminophen as part of multimodal analgesia. The investigators will evaluate the effects of an opioid-free anesthesia on pain scores, analgesic medication consumption during the initial two postoperative hours, and time to discharge from PACU, compared to an opioid-containing anesthesia.The investigators will also compare the prevalence of opioid-related sedation side effect between opioid-free anesthesia and opioid-containing anesthesia.
Setting and Population Inclusion Criteria
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Written informed consent 2. 18-45 years old 3. American Society of Anesthesiologists (ASA) physical status 1-2 4. Undergoing oocyte retrieval procedures 5. Planned number of oocytes to be retrieved <15 Exclusion Criteria
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Known allergy to fentanyl, acetaminophen, dipyrone, lidocaine, propofol or NSAIDs.
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Endometriosis
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Diagnosis of chronic pain
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Opioid dependency, defined by consumption of oral morphine equivalent of greater than or equal to 60mg a day for 7 days or longer, for any time period.
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Weight < 50 kg
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Cannabis use
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Major psychiatric disorder - Schizophrenia, bipolar disorder, major depression.
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Epilepsy disorder under anti-convulsant therapy.
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Renal insufficiency, defined as creatinine clearance <60 ml/hr
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Hepatic disease
Withdrawal Criteria
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •18-45 years old
- •American Society of Anesthesiologists (ASA) physical status 1-2
- •Undergoing oocyte retrieval procedures
- •Planned number of oocytes to be retrieved <15
排除标准
- •Known allergy to fentanyl, acetaminophen, dipyrone, lidocaine, propofol or NSAIDs.
- •Endometriosis
- •Diagnosis of chronic pain
- •Opioid dependency, defined by consumption of oral morphine equivalent of greater than or equal to 60mg a day for 7 days or longer, for any time period.
- •Weight < 50 kg
- •Cannabis use
- •Major psychiatric disorder - Schizophrenia, bipolar disorder, major depression.
- •Epilepsy disorder under anti-convulsant therapy.
- •Renal insufficiency, defined as creatinine clearance <60 ml/hr
- •Hepatic disease
研究组 & 干预措施
Opioid-free anesthesia
- IV propofol 1-1.5 mg/kg
- IV acetaminophen 1000mg
- IV dipyrone 1000mg
- IV lidocaine 1mg/kg
- IV dexacort 4mg
- PR diclofenac 50 mg
干预措施: IV acetaminophen (Drug)
Opioid-supplemented anesthesia
- IV propofol 1-1.5 mg/kg
- IV fentanyl 1.5 mcg/kg
- IV dipyrone 1000mg
- IV lidocaine 1mg/kg
- IV dexacort 4mg
- PR diclofenac 50 mg
干预措施: IV fentanyl (Drug)
结局指标
主要结局
the difference in average pain scores
时间窗: 1 year
We will test the difference in average pain scores between the groups in a non-inferiority model. All pain scores obtained during the initial two postoperative hours will be averaged and compared between the groups. The non-inferiority delta will be defined a priori as no worse than 1.5 points in average pain score. Overall alpha will be 0.05. NRS Scale from 0-10, zero is no pain.
the dependent categorical variable of time-to-discharge readiness
时间窗: 1 year
The secondary analysis will compare the dependent variable of time-to-discharge from postanesthesia care unit (PACU) readiness at 60 mins (yes/no) between the two study groups and will be reported as number (proportions). We will also record the time from arrival until discharge from PACU reported as the median \[interquartile range\] time in each group. Overall alpha will be 0.05.
次要结局
未报告次要终点