Clinical trial NCT03992079: A Multimodal Enhanced Recovery Program in Anorectal Surgery
Official title: A Single Institutional Randomized Controlled Trial for A Multimodal Enhanced Recovery Program in Anorectal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Disorders
Anorectal Disorder
Patient Satisfaction
Pain, Postoperative
Opioid Use
Opioid Abuse
Opioid Dependence
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients in whom surgery is planned via an anorectal approach for hemorrhoids, fissures, or fistula disease.

Exclusion Criteria:

* Patients are not eligible if currently or chronically (more than 7 days prior to presentation) on opioid medication or opioid-receptor antagonist medication.

Primary outcomes:
measure: Rate of Opioid Use
timeFrame: Up to 30 days post surgery
Secondary outcomes:
measure: Pain Score on the Visual Analog Scale (VAS)
timeFrame: Up to 30 days post surgery
measure: Pain Score on the Functional Pain Scale (FPS)
timeFrame: Up to 30 days post surgery
measure: Score on the EQ-5D-3L
timeFrame: Up to 30 days post surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Deborah S. Keller, MS, MD
role: PRINCIPAL_INVESTIGATOR
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