A Multimodal Enhanced Recovery Program in Anorectal Surgery
Stopped early · Not applicable
Conditions studied: Colorectal Disorders, Anorectal Disorder, Patient Satisfaction, Pain, Postoperative, Opioid Use, Opioid Abuse, Opioid Dependence
In brief
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.
Key facts
- Study ID
- NCT03992079
- Run by
- Columbia University
- People needed
- 60
- Starts
- 2019-06-20
- Expected to finish
- 2020-05-21
- Last updated by the study team
- 2020-08-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients in whom surgery is planned via an anorectal approach for hemorrhoids, fissures, or fistula disease.
You may not qualify if…
- Patients are not eligible if currently or chronically (more than 7 days prior to presentation) on opioid medication or opioid-receptor antagonist medication.
Where it is running
- Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.