Administration of Rectal Acetaminophen During Oocyte Retrievals Reduces Post-Operative Opioid Utilization in Fertility Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized
研究概览
简要总结
The primary aim of this study is to evaluate the administration of rectal acetaminophen to current and standard anesthesia and analgesia protocol in oocyte retrievals would reduce postoperative utilization of opioids (Tylenol with codeine) in fertility patients.
详细描述
As the opioid epidemic shows no sign of abating, this national crisis deserves careful attention from all medical subspecialties. This includes reproductive endocrinology and infertility (REI), where opioids are primarily utilized for intraoperative and postoperative pain management for outpatient procedures such as oocyte retrievals, operative hysteroscopy, and laparoscopic myomectomy. The purpose of this study is to evaluate whether the administration of rectal acetaminophen in addition to the current, standard anesthesia and analgesia protocol in oocyte retrievals can help decrease utilization of prescribed opioid at home following oocyte retrieval. Rectal acetaminophen will be used rather than conventional IV acetaminophen because of the lack of access to IV acetaminophen at the study institution. Rectal acetaminophen is appealing because it is cheap, readily available in most medical centers and there is the potential for increased analgesic benefit due to the proximity to the vaginal and ovarian tissue, as well as the possible benefit from the partial avoidance of hepatic first-pass metabolism. This trial has the potential to provide practice-changing clinical information to the field of REI. The information gained can even translate to other ambulatory procedures and guide clinical practice. The investigators hypothesize that participants given rectal acetaminophen in addition to standard anesthesia/analgesia at the end of their oocyte retrieval will use less amount of prescribed Tylenol with codeine 3 days after discharge from the surgery center compared those receiving standard anesthesia/analgesia for oocyte retrieval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 56 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Any female patient undergoing oocyte retrieval by transvaginal ultrasound-guided ovarian puncture
排除标准
- •Patients with chronic pain conditions such as fibromyalgia and sickle cell anemia.
- •Patient with BMI greater than 40
- •Patients that required general endotracheal intubation anesthesia in prior oocyte retrieval
- •Patients with documented allergic reaction to acetaminophen
- •Patient with contra-indication to the use of acetaminophen (liver disease)
- •Patients with a history of past or current alcohol, drug or opioid abuse
- •Patients with ulcerative colitis, Crohn's disease, or severe rectal hemorrhoids
研究组 & 干预措施
Fentanyl/propofol + acetaminophen
In addition to the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol, one dose of 1300 mg of solid base rectal acetaminophen suppository (2 suppositories) will be administered at the end of oocyte retrieval.
干预措施: Acetaminophen (Drug)
Fentanyl/propofol + acetaminophen
In addition to the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol, one dose of 1300 mg of solid base rectal acetaminophen suppository (2 suppositories) will be administered at the end of oocyte retrieval.
干预措施: Fentanyl (Drug)
Fentanyl/propofol + acetaminophen
In addition to the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol, one dose of 1300 mg of solid base rectal acetaminophen suppository (2 suppositories) will be administered at the end of oocyte retrieval.
干预措施: Propofol (Drug)
Fentanyl/propofol only
Participants in this arm will receive the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol.
干预措施: Fentanyl (Drug)
Fentanyl/propofol only
Participants in this arm will receive the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol.
干预措施: Propofol (Drug)
结局指标
主要结局
Proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized
时间窗: 72 hours following oocyte retrieval
The proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized 72 hours postoperatively will be assessed by telephone encounter. A total of 10 tablets of Tylenol #3 will be prescribed to each participant. Fewer Tylenol #3 used at the end of this time frame would indicate better outcome.
次要结局
- Pain score in post-anesthesia care unit using the Visual Analog Scale(1-hour after oocyte retrieval)
- 24-hour pain score using the Visual Analog Scale(24 hours after oocyte retrieval)
- 48-hour pain score using the Visual Analog Scale measuring pain(48 hours after oocyte retrieval)
- 72-hour pain score using the Visual Analog Scale measuring pain(72 hours after oocyte retrieval)
