A Multimodal Enhanced Recovery Program in Anorectal Surgery (ARSE)

Columbia University

Status: Terminated

Conditions: Opioid Abuse; Patient Satisfaction; Colorectal Disorders; Anorectal Disorder; Pain, Postoperative; Opioid Use; Opioid Dependence

Treatments: Procedure: ReCOVER Enhanced Recovery Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT03992079

AAAS3302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Control

No Intervention group

Description:

The control group will receive standard preoperative and postoperative directions, with the anesthesiologist and surgeon's preferences for analgesia during and after surgery.

Experimental

Experimental group

Description:

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.

Treatment:

Procedure: ReCOVER Enhanced Recovery Protocol