A Multimodal Enhanced Recovery Program in Anorectal Surgery (ARSE)
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|ClinicalTrials.gov Identifier: NCT03992079|
Recruitment Status : Terminated (PI is no longer at institution)
First Posted : June 20, 2019
Last Update Posted : August 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Disorders Anorectal Disorder Patient Satisfaction Pain, Postoperative Opioid Use Opioid Abuse Opioid Dependence||Procedure: ReCOVER Enhanced Recovery Protocol||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||After providing written informed consent, patients will be randomly assigned in a 1:1 ratio to either the control group, which uses physician preference for pain control, and generally relies on extended opioids or the experimental group, which includes preemptive pain control, targeted education, and multimodal opioid-sparing pain management during the intraoperative and postoperative periods.|
|Masking:||Double (Care Provider, Investigator)|
|Masking Description:||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.|
|Official Title:||A Single Institutional Randomized Controlled Trial for A Multimodal Enhanced Recovery Program in Anorectal Surgery|
|Actual Study Start Date :||June 20, 2019|
|Actual Primary Completion Date :||May 21, 2020|
|Actual Study Completion Date :||May 21, 2020|
No Intervention: Control
The control group will receive standard preoperative and postoperative directions, with the anesthesiologist and surgeon's preferences for analgesia during and after surgery.
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.
Procedure: ReCOVER Enhanced Recovery Protocol
The experimental group will receive preemptive pain management before surgery, an opioid-free strategy during surgery, and an opioid-sparing multimodal pain management protocol after surgery.
- Rate of Opioid Use [ Time Frame: Up to 30 days post surgery ]Postoperative opioid use will be measured in morphine milligram equivalents per day (MME)
- Pain Score on the Visual Analog Scale (VAS) [ Time Frame: Up to 30 days post surgery ]A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain (score of 0) and the other end meaning the worst pain imaginable (score of 100). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
- Pain Score on the Functional Pain Scale (FPS) [ Time Frame: Up to 30 days post surgery ]The Functional Pain Scale (FPS) was developed in 2001 to evaluate the effect of pain on patient function for various different types of pain. The scale ranges from 0-5 and the participants score will fall within this range 0-5 range based a combination of their subjective rating of pain and their objective opinion about how that pain interferes with daily activities. A lower score is linked to lower levels of pain and reduced interference from pain on daily activities.
- Score on the EQ-5D-3L [ Time Frame: Up to 30 days post surgery ]The EQ-5D-3L queries across five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has levels ranging from no problems (score of 1) to extreme problems (score of 5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The final "score" is coded based on the 5 responses.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992079
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Deborah S. Keller, MS, MD||Columbia University|