NCT03992079

A Multimodal Enhanced Recovery Program in Anorectal Surgery

A Single Institutional Randomized Controlled Trial for A Multimodal Enhanced Recovery Program in Anorectal Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Disorders
• Anorectal Disorder
• Patient Satisfaction
• Pain, Postoperative
• Opioid Use
• Opioid Abuse
• Opioid Dependence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-20
• Primary completion: 2020-05-21
• Completion: 2020-05-21
• First posted: 2019-06-20
• Last updated: 2020-08-25

Locations

1 site across 1 country: United States