Pain, Postoperative Clinical Trial
— ARSEOfficial title:
A Single Institutional Randomized Controlled Trial for A Multimodal Enhanced Recovery Program in Anorectal Surgery
NCT number | NCT03992079 |
Other study ID # | AAAS3302 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | June 20, 2019 |
Est. completion date | May 21, 2020 |
Verified date | August 2020 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 60 |
Est. completion date | May 21, 2020 |
Est. primary completion date | May 21, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Opioid Use | Postoperative opioid use will be measured in morphine milligram equivalents per day (MME) | Up to 30 days post surgery | |
Secondary | Pain Score on the Visual Analog Scale (VAS) | 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. | Up to 30 days post surgery | |
Secondary | Pain Score on the Functional Pain Scale (FPS) | 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. | Up to 30 days post surgery | |
Secondary | Score on the EQ-5D-3L | 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. | Up to 30 days post surgery |
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