A Phase 4 interventional study of ERAS and Standard of care in Anorectal Disorder, sponsored by Cedars-Sinai Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-18.
Sponsored by Cedars-Sinai Medical Center · Phase 4, Interventional, and Treatment
The purpose of the study is to evaluate whether being randomized to an aggressive postoperative non-narcotic pain regimen that treats pain from multiple different pathways may decrease postoperative pain levels, decrease constipation, and decrease the dependency on opioid medications after anorectal surgery versus the standard of care for managing pain. This use of a more aggressive pain regimen is considered an enhanced recovery after surgery (ERAS) protocol because it is theorized to improve or "enhance" postoperative recovery by both decreasing the use of narcotics and their detrimental effects as well as increasing the benefit of using additional non-narcotic pain medication.
Although pain is a predictable part of the postoperative experience, inadequate management of pain is common and can have profound implications Most patients who undergo surgical procedures experience acute postoperative pain, but evidence suggests that less than half report adequate postoperative pain relief. Many preoperative, intraoperative, and postoperative interventions and management strategies are available for reducing and managing postoperative pain. Mostly, pain is treated with opioids which are narcotics. medically they are primarily used for pain relief and these are historically considered "safe" drugs as they do not impose an increased risk of bleeding, kidney, or stomach problems. However, many patients taking high dose opioids have a higher risk of constipation. Unrelieved postoperative pain may result in economic and medical implications such as extended lengths of stay, readmissions, and patient dissatisfaction with medical care. With the rising concern over narcotic use, physicians are increasingly seeking alternative ways to help patients manage pain throughout their hospital stay and beyond However, few studies in anorectal surgery have shown that using an aggressive postoperative non-narcotic pain regimen (ERAS) can help reduce postoperative pain and decreased returns to emergency care.
87 studies on the registry are indexed under Rectal Diseases; 14 are open to participants now.
This study's enrollment of 111 is close to the median of 114 across 59 interventional studies indexed under Rectal Diseases.
Browse Rectal Diseases studies →Cedars-Sinai Medical Center is the lead sponsor of 456 studies on the registry; 107 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm1 (Multimodal ERAS): Preoperative: oral gabapentin 600mg and oral acetaminophen 1,000mg Postoperative pain control: 1. Gabapentin oral 300 mg TID (#42, refill #1) 2. Acetaminophen oral 1000mg TID (#42, refill #1) 3. Ketorolac oral 10 mg TID (#15, refill #0) 4. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) Postoperative laxative regimen: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. Daily milk of magnesia 1 tablespoon if no bowel movement by POD2 until regular bowel movements 3. Daily mineral oil 1 table spoon if no bowel movement by POD2 until regular bowel movements
Combination Product: ERAS
Postoperative pain control: 1. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) 2. Patients will be allowed to take oral acetaminophen and ibuprofen over the counter if needed but active narcotic-sparing pain management regimen will not be implemented Postoperative laxative regimen: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. Daily milk of magnesia 1 tablespoon if no bowel movement by POD2 until regular bowel movements Daily mineral oil 1 table spoon if no bowel movement by POD2 until regu-lar bowel movements
Combination Product: Standard of care
Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol
Oxcodone PO Ketorolac IV only (intraop)
Total Narcotic Use Postoperatively in Oral Morphine Equivalents
Total amount of narcotics used
Time frame: 1 week postoperatively
Median Postoperative Pain Scores
Level of pain measured on a scale of 0-10 with 0 being the lowest level of pain and 10 being the highest level of pain as reported by the participant
Time frame: 1 week postoperatively
Complications
Number of participants who experienced complications
Time frame: 1 month postoperatively
| Milestone | Arm 1 (Multimodal ERAS) | Arm 2 (Control) |
|---|---|---|
| Started | 54 | 55 |
| Completed | 45 | 44 |
| Not completed | 9 | 11 |
Total amount of narcotics used
| Oral morphine miligram equivalents | Arm 1 (Multimodal ERAS) | Arm 2 (Control) |
|---|---|---|
| Total Narcotic Use Postoperatively in Oral Morphine Equivalents | 8 (0 to 390) | 79 (0 to 600) |
Level of pain measured on a scale of 0-10 with 0 being the lowest level of pain and 10 being the highest level of pain as reported by the participant
| score on a scale | Arm 1 (Multimodal ERAS) | Arm 2 (Control) |
|---|---|---|
| Median Postoperative Pain Scores | 4 (0 to 10) | 6 (0 to 10) |
Number of participants who experienced complications
| Participants | Arm 1 (Multimodal ERAS) | Arm 2 (Control) |
|---|---|---|
| Complications | 4 | 2 |
Collected over 30 days postoperatively. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 (Multimodal ERAS) | 0/45 (0%) | 0/45 (0%) | 4/45 (8.9%) |
| Arm 2 (Control) | 0/44 (0%) | 0/44 (0%) | 2/44 (4.5%) |
| Event | Arm 1 (Multimodal ERAS) | Arm 2 (Control) |
|---|---|---|
| Adverse event not resulting in significant morbidity or mortalitySurgical and medical procedures | 4/45 | 2/44 |
| Age, Categorical(Participants) | Arm 1 (Multimodal ERAS) | Arm 2 (Control) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 44 | 44 | 88 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | Arm 1 (Multimodal ERAS) | Arm 2 (Control) | Total |
|---|---|---|---|
| Median | 38 (20 to 67) | 38 (23 to 59) | 38 (20 to 67) |
| Sex: Female, Male(Participants) | Arm 1 (Multimodal ERAS) | Arm 2 (Control) | Total |
|---|---|---|---|
| Female | 25 | 16 | 41 |
| Male | 20 | 28 | 48 |
| Race and Ethnicity Not Collected(Participants) | Arm 1 (Multimodal ERAS) | Arm 2 (Control) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Arm 1 (Multimodal ERAS) | Arm 2 (Control) | Total |
|---|---|---|---|
| United States | 45 | 44 | 89 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2018 to primary completion in Aug 2022, 45 months.
Results were first posted in Dec 2023, 1 year 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.