Evaluating the Effect of Preoperative Patient Education on Postoperative Opioid Consumption, Storage, and Disposal After Urogynecologic Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 6
- 主要终点
- 2 week postoperative opioid consumption
研究概览
简要总结
The purpose of this randomized controlled trial is to evaluate whether preoperative opioid education will reduce postoperative opioid consumption after urogynecologic surgeries. Additionally, the effect of the opioid education on opioid storage and disposal patterns will be evaluated. The pattern of opioid consumption 2 and 6 weeks after surgery will be compared between patients in the study arms. The rates of prescription refills 12 weeks and 12 months after the surgery will be compared between patients in the study arms.
详细描述
The study concept would be introduced to the patients at the prior to or during the preoperative visit. If the patient agrees to participation during any of these encounters, written consent and HIPPA authorization will be obtained and the patient would be randomized to the intervention or control arm using a computerized randomization scheme on REDCap. The randomization will be stratified by hospital system the surgery was performed within (UC Irvine Medical Center versus Kaiser Permanente Southern California). If the patient is randomized to the intervention arm, the first opioid informational pamphlet will be provided and reviewed with the patient in addition to standard preoperative instructions. If the patient is randomized to the control arm, standard preoperative instructions will be provided. Patients within both arms of the study will receive standardized postoperative medication prescriptions prior to the surgery. Patients within both arms of the study will complete the modified surgical pain score and preoperative opioid education study survey prior to surgery.
After the surgery is completed, the primary surgeon will decide whether to admit the patient to the hospital and which postoperative analgesics will be administered within the hospital prior to discharge for subjects in both study arms. The patient will follow up for standard postoperative clinic visits at 2 weeks and 6 weeks postoperatively. One to two days prior to the 2 week postoperative visit, the patients will be contacted via telephone to remind them to bring their opioid prescription bottles to the clinic visit.
Between the surgery date and the 2 week postoperative visit, the electronic medical records will be reviewed to evaluate the length of the surgery, intraoperative complications, the postoperative date of discharge, the postoperative date of removal of the transurethral foley catheter, the total daily morphine equivalents that the patient was prescribed prior to discharge from the hospital, and the presence of opioid prescriptions 30 days prior to the surgery. Additionally, the CURES 2.0 Database will be queried to evaluate for opioid prescriptions 30 days prior to the surgery.
During the 2 week postoperative visit, the remaining opioid tablets will be counted and recorded by a co-investigator. The patient will complete the modified surgical pain score and postoperative opioid education study survey. The electronic medical record system and CURES 2.0 Database will be queried to evaluate for additional opioid prescriptions since the time of surgery. Patients randomized to the intervention arm will receive the second opioid informational pamphlet, which will be reviewed by a co-investigator.
During the 6 week the patient will complete the modified surgical pain score and postoperative opioid education study survey. The electronic medical record system and CURES 2.0 Database will be queried to evaluate for additional opioid prescriptions since the time of surgery. The patients' electronic medical records will be reviewed after the 6 week postoperative visit to evaluate for postoperative complications.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-99 years old
- •English speaking
- •Evaluated by a provider within the Urogynecology division at UC Irvine Medical Center, Kaiser Permanente Orange County - Irvine Medical Center, or Kaiser Permanente Orange County - Anaheim Medical Center, and consented for either a uterosacral ligament suspension, sacrospinous ligament fixation, minimally-invasive colpopexy (either laparoscopic or robotic-assisted laparoscopic), colporrhaphy, or colpocleisis
排除标准
- •Non English-speaking
- •Cognitive deficits that would prevent the patient from completing the study questionnaires
- •Cancellation of the surgery
- •Combined case with another surgical service (i.e. colorectal surgery)
结局指标
主要结局
2 week postoperative opioid consumption
时间窗: 2 weeks after the surgery
Mean number of opioid tablets consumed 2 weeks postoperatively
次要结局
- Modified Surgical Pain Score(Between the preoperative assessment and 6 weeks after surgery)
- Postoperative complications(The electronic medical record will be reviewed 6 weeks after surgery. This data point will be included in the initial analysis that will be performed after the last enrolled patient has completed the 12 week postoperative chart review.)
- Postoperative Oral Morphine Equivalents Prior to Discharge(The electronic medical record will be reviewed 2 weeks after surgery. This data point will be included in the initial analysis that will be performed after the last enrolled patient has completed the 12 week postoperative chart review.)
- Additional opioid prescriptions(To be performed three times between 2 weeks to 12 months after the surgery. This data point will be included in the initial analysis that will be performed after the last enrolled patient has completed the 12 week postoperative chart review.)
- Preoperative Patient Survey answers(To be collected within 30 days prior to surgery. This data point will be included in the initial analysis that will be performed after the last enrolled patient has completed the 12 week postoperative chart review.)
- Intraoperative complications(These will be evaluated within the first 6 weeks after surgery. This data point will be included in the initial analysis that will be performed after the last enrolled patient has completed the 12 week postoperative chart review.)
- Postoperative Patient Survey answers(Conducted two times 2 weeks and 6 weeks after surgery. This data point will be included in the initial analysis that will be performed after the last enrolled patient has completed the 12 week postoperative chart review.)