A Single Institutional Randomized Controlled Trial for A Multimodal Enhanced Recovery Program in Anorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of Opioid Use
研究概览
简要总结
The goal of this study is to establish whether an opioid-sparing Enhanced Recovery After Surgery (ERAS) program in ambulatory anorectal surgery can be safely introduced at a single tertiary referral center without an increase in postoperative pain or negative impact on the patient experience. A single-center, single-blinded randomized control trial is proposed, where patients will be assigned in a 1:1 ratio to either usual care, which includes extended opioids (control group) or the enhanced recovery group (experimental), which includes preemptive pain control, targeted education, and multimodal opioid-sparing pain management during the intraoperative and postoperative periods. The expected outcome is that the enhanced recovery program will significantly reduce opioid utilization with comparable pain scores and patient satisfaction after anorectal surgery.
详细描述
There is an opioid epidemic in the United States, and the epidemic continues to worsen. The rate of opioids prescribed, distributed, and deaths from opioid overdoses continue to increase steadily. Opioids also have the costs of abuse, dependence, diversion of unused medication, and can serve as a gateway to other illegal substances. Opioid use often begins with treatment of acute postoperative pain, and the surgical episode can be a 'gateway' to the opioid crisis. Opioids remain ubiquitous in patients undergoing surgical procedures. Among opioid-naïve patients, persistent use after surgery occurs in 6-10%.
Ambulatory surgery cases are rarely mentioned in the context of this public health crisis, but are a major contributor to the problem. Opioids are ubiquitous after ambulatory anorectal surgery and prescribed in large quantities, often several times more than what is needed or taken by patients. As patients take a fraction of the opioids prescribed, this adds to issues of opioid diversion. In colorectal surgery, ambulatory anorectal procedures are common and frequent procedures, with the potential to impact a large number of patients when implementing quality improvement. Thus, study into ERAS and ways to reduce opioids after ambulatory anorectal surgery is warranted.
This application challenges the notion that inpatient surgery should be the only target for enhanced recovery and opioid interventions. It seeks to shift the clinical practice paradigm that extended opioids are necessary after ambulatory anorectal surgery. This new application of ERAS to ambulatory anorectal surgery could address a critical barrier to progress in reducing opioids in procedures that are common but underrepresented in current research.
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
- Double (Care Provider, Investigator)
盲法说明
Randomization will be conducted by means of a secure website (Sealed Envelope), with block randomization to help balance the groups by the procedures performed within each arm. The patients, post-anesthesia care unit (PACU) staff, and study investigators performing follow up assessments, collecting, and analyzing the data will be unaware of the treatment assignments. It is not feasible to blind the operating team or site enrolment personnel as different preoperative and discharge information, medication and patient education will be given to the experimental and control groups. A numbered, sealed envelope, corresponding to the patient's assigned study number, will be opened, and the research coordinator will alert the surgeon to the patient's group assignment. Using the assumption that patients do not know the difference between enhanced recovery and usual care, the patient will not be informed of which arm they are assigned to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in whom surgery is planned via an anorectal approach for hemorrhoids, fissures, or fistula disease.
排除标准
- •Patients are not eligible if currently or chronically (more than 7 days prior to presentation) on opioid medication or opioid-receptor antagonist medication.
研究组 & 干预措施
Control
The control group will receive standard preoperative and postoperative directions, with the anesthesiologist and surgeon's preferences for analgesia during and after surgery.
Experimental
The experimental group will receive routine directions for surgery and a ReCOVER patient education document on the Enhanced Recovery protocol, with instructions on preoperative preparation, postoperative wound care, pain management, preventing and managing constipation, activity limitations, and return precautions. The information sheet will be provided to patients in clinic and reviewed with a member of the healthcare team to ensure an understanding of the plan.
干预措施: ReCOVER Enhanced Recovery Protocol (Procedure)
结局指标
主要结局
Rate of Opioid Use
时间窗: Up to 30 days post surgery
Postoperative opioid use will be measured in morphine milligram equivalents per day (MME)
次要结局
- Score on the EQ-5D-3L(Up to 30 days post surgery)
- Pain Score on the Visual Analog Scale (VAS)(Up to 30 days post surgery)
- Pain Score on the Functional Pain Scale (FPS)(Up to 30 days post surgery)