Eliminating Narcotic Prescriptions from Outpatient Minimally Invasive Gynecologic Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Pain score on post-operative day one
研究概览
简要总结
Laparoscopic gynecologic surgeries are generally very well tolerated procedures, and patients are able to go home on the same day, with a prescription for pain control. There is currently a very wide range of prescription practice within the gynecology community in regards to opioids following surgery, and patients are going home with anything from zero to 5 or even 20 tabs of narcotics.
Aside from negative side effect of opioids (like nausea/vomiting, dizziness, constipation, and possibly addiction), unnecessary opioid prescriptions and excess unused narcotics is one of the major contributors to narcotic abuse in the community, worsening an ongoing nationwide opioid crisis. Although most patients report low pain level following these kinds of procedure, there are no current standard prescriptions after gynecologic laparoscopy.
In an effort to standardize discharge prescriptions following gynecologic laparoscopy, this study aims to find an optimal regimen for pain control in the post-operative period following laparoscopic gynecologic surgery. There will be 2 standardized set of discharge prescriptions to which patient will be randomized; both containing multimodal medications for pain control. Pain control, and patients satisfaction will be measured in the first post-operative week.
详细描述
Narcotic prescribing patterns vary greatly among gynecologists performing minimally invasive gynecologic surgery (MIGS). There is no clear consensus or established guideline regarding the choice of narcotic or total amount to be prescribed, if any, for MIGS. These represent a generally well-tolerated group of procedures that are less painful than conventional open surgery. Unnecessary opioid prescriptions and excess unused narcotics have been identified as major contributors to narcotic abuse in the community, and efforts geared towards minimizing unnecessary narcotic prescriptions may help curb the growing opioid crisis.
This study suggests eliminating opioids from discharge prescriptions following outpatient MIGS in select patients. Given the general tolerability and low pain associated with MIGS, the investigators hypothesize that elimination of narcotics from post-operative pain control, in conjunction with regular use of non-narcotic analgesics, will result in analgesia and early recovery that is no worse than a standard narcotic-containing discharge prescription.
Women undergoing elective outpatient laparoscopic gynecologic surgery at two medical center associated with the McGill University Health Centre will be recruited and screened for exclusion criteria. Patients will be randomly allocated to either intervention or control groups in a one to one fashion. Patients in both intervention and control group will undergo surgery under a standardized anesthesia protocol. Important surgical steps that can affect post-operative pain will be standardised and recorded with a surgical checklist to reduce inter-surgeon variability. Patient allocated to the intervention arm will then be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then as needed for one week's duration. Patient in control group will be discharge with a standard prescription of five tabs of 1 mg hydromorphone, with regular non-opioid analgesic use.
All patient will be contacted on day one and seven after surgery to evaluate pain scores, mobility, adequacy of analgesia, adherence to treatment, side-effects, and total opioid consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Although the patient and operative team will not be blinded to the allocation, the research team member completing the post-operative questionnaires as well as the statistician responsible for data analysis will remain blinded to the allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing elective outpatient gynecologic laparoscopy
- •Able to provide informed consent
- •Planned for same day discharge
排除标准
- •Chronic pain conditions including, but not limited to: chronic pelvic pain, fibromyalgia, connective tissue disorders, migraines on medication, severe osteoarthritis, sciatica, degenerative disk disease
- •Regular use of analgesia or narcotics. Defined as use of pain medication on most days of the week, most weeks of the month
- •History of substance abuse (opioid addiction, IV drug use, etc.)
- •Known depression or anxiety conditions with or without medication
- •Eastern Cooperative Oncology Group (ECOG) performance status 3 or greater
- •Current or recent use of pain modulators such as pregabalin or gabapentin (one month pre-operatively).
- •Allergy or contraindication to acetaminophen or NSAIDs or hydromorphone/narcotics
- •Intraoperative complications :
- •Conversion to laparotomy or mini-laparotomy > 4 cm
- •Intra-operative gastrointestinal or urologic injury
- •Intra-operative hemorrhage or need for blood transfusion
- •Need for admission
研究组 & 干预措施
Acetaminophen and naproxen only arm
Patient allocated to the intervention arm will be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then as needed for one week's duration.
干预措施: prescription for regular acetaminophen and naproxen (Other)
Acetaminophen, naproxen and dilaudid arm
Patient allocated to the control group will be discharged home with a prescription for regular acetaminophen, naproxen, and 5 tabs of hydromorphone 1 mg, with instruction to prioritize non opioid analgesic as first line.
干预措施: prescription for regular acetaminophen , naproxen and dilaudid (Other)
结局指标
主要结局
Pain score on post-operative day one
时间窗: Post-operative day one
The primary outcome of this study is patient reported pain using an 11-point Numerical Rating Scale (NRS) on post-operative day two, on a scale from 0 to 10 in which higher scores indicate higher pain (worse pain control).
次要结局
- Patient mobility and satisfaction of analgesia(Post-operative day one and seven)
- Opioid related side effect(First post-operative week (Day 7))
- Unplanned return to emergency room / clinic(First post-operative week (Day 7))
- Pain score on post-operative day one(Post-operative day 7)
- Total narcotic consumption in the first post-operative week(Post-operative day seven)
- Overall satisfaction with pain control(First post-operative week (Day 7))
研究者
Andrew Zakhari
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre