A Multimodal Enhanced Recovery Program in Anorectal Surgery (ARSE)
24 agosto 2020 aggiornato da: Columbia University
A Single Institutional Randomized Controlled Trial for A Multimodal Enhanced Recovery Program in Anorectal Surgery
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.
Panoramica dello studio
Stato
Terminato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
60
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10032
- Columbia University Medical Center
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Nessun intervento: Control
The control group will receive standard preoperative and postoperative directions, with the anesthesiologist and surgeon's preferences for analgesia during and after surgery.
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Sperimentale: Experimental
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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Rate of Opioid Use
Lasso di tempo: Up to 30 days post surgery
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Postoperative opioid use will be measured in morphine milligram equivalents per day (MME)
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Up to 30 days post surgery
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pain Score on the Visual Analog Scale (VAS)
Lasso di tempo: Up to 30 days post surgery
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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.
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Up to 30 days post surgery
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Pain Score on the Functional Pain Scale (FPS)
Lasso di tempo: Up to 30 days post surgery
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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.
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Up to 30 days post surgery
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Score on the EQ-5D-3L
Lasso di tempo: Up to 30 days post surgery
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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.
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Up to 30 days post surgery
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Deborah S. Keller, MS, MD, Columbia University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Carmichael JC, Keller DS, Baldini G, Bordeianou L, Weiss E, Lee L, Boutros M, McClane J, Feldman LS, Steele SR. Clinical Practice Guidelines for Enhanced Recovery After Colon and Rectal Surgery From the American Society of Colon and Rectal Surgeons and Society of American Gastrointestinal and Endoscopic Surgeons. Dis Colon Rectum. 2017 Aug;60(8):761-784. doi: 10.1097/DCR.0000000000000883. No abstract available.
- Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.
- Gloth FM 3rd, Scheve AA, Stober CV, Chow S, Prosser J. The Functional Pain Scale: reliability, validity, and responsiveness in an elderly population. J Am Med Dir Assoc. 2001 May-Jun;2(3):110-4.
- Tan M, Law LS, Gan TJ. Optimizing pain management to facilitate Enhanced Recovery After Surgery pathways. Can J Anaesth. 2015 Feb;62(2):203-18. doi: 10.1007/s12630-014-0275-x. Epub 2014 Dec 10.
- Swarup A, Mathis KA, Hill MV, Ivatury SJ. Patterns of opioid use and prescribing for outpatient anorectal operations. J Surg Res. 2018 Sep;229:283-287. doi: 10.1016/j.jss.2018.04.005. Epub 2018 May 9.
- Rose KR, Christie BM, Block LM, Rao VK, Michelotti BF. Opioid Prescribing and Consumption Patterns following Outpatient Plastic Surgery Procedures. Plast Reconstr Surg. 2019 Mar;143(3):929-938. doi: 10.1097/PRS.0000000000005351.
- Harris K, Curtis J, Larsen B, Calder S, Duffy K, Bowen G, Hadley M, Tristani-Firouzi P. Opioid pain medication use after dermatologic surgery: a prospective observational study of 212 dermatologic surgery patients. JAMA Dermatol. 2013 Mar;149(3):317-21. doi: 10.1001/jamadermatol.2013.1871.
- Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in urological practice. J Urol. 2011 Feb;185(2):551-5. doi: 10.1016/j.juro.2010.09.088. Epub 2010 Dec 18.
- Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272.
- Kenan K, Mack K, Paulozzi L. Trends in prescriptions for oxycodone and other commonly used opioids in the United States, 2000-2010. Open Med. 2012 Apr 10;6(2):e41-7. Print 2012.
- Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers---United States, 1999--2008. MMWR Morb Mortal Wkly Rep. 2011 Nov 4;60(43):1487-92.
- Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.
- Florence CS, Zhou C, Luo F, Xu L. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. Med Care. 2016 Oct;54(10):901-6. doi: 10.1097/MLR.0000000000000625.
- Baker DW. History of The Joint Commission's Pain Standards: Lessons for Today's Prescription Opioid Epidemic. JAMA. 2017 Mar 21;317(11):1117-1118. doi: 10.1001/jama.2017.0935. No abstract available.
- Kessler ER, Shah M, Gruschkus SK, Raju A. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy. 2013 Apr;33(4):383-91. doi: 10.1002/phar.1223.
- Lee JS, Hu HM, Edelman AL, Brummett CM, Englesbe MJ, Waljee JF, Smerage JB, Griggs JJ, Nathan H, Jeruss JS, Dossett LA. New Persistent Opioid Use Among Patients With Cancer After Curative-Intent Surgery. J Clin Oncol. 2017 Dec 20;35(36):4042-4049. doi: 10.1200/JCO.2017.74.1363. Epub 2017 Oct 19.
- Carroll I, Barelka P, Wang CK, Wang BM, Gillespie MJ, McCue R, Younger JW, Trafton J, Humphreys K, Goodman SB, Dirbas F, Whyte RI, Donington JS, Cannon WB, Mackey SC. A pilot cohort study of the determinants of longitudinal opioid use after surgery. Anesth Analg. 2012 Sep;115(3):694-702. doi: 10.1213/ANE.0b013e31825c049f. Epub 2012 Jun 22.
- Van Backer JT, Jordan MR, Leahy DT, Moore JS, Callas P, Dominick T, Cataldo PA. Preemptive Analgesia Decreases Pain Following Anorectal Surgery: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial. Dis Colon Rectum. 2018 Jul;61(7):824-829. doi: 10.1097/DCR.0000000000001069.
- Parrish AB, O'Neill SM, Crain SR, Russell TA, Sonthalia DK, Nguyen VT, Aboulian A. An Enhanced Recovery After Surgery (ERAS) Protocol for Ambulatory Anorectal Surgery Reduced Postoperative Pain and Unplanned Returns to Care After Discharge. World J Surg. 2018 Jul;42(7):1929-1938. doi: 10.1007/s00268-017-4414-8.
Collegamenti utili
- Centers for Disease Control and Prevention. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics; 2017.
- Center for Behavioral Health Statistics and Quality. (2017). 2016 National Survey on Drug Use and Health: Detailed Tables. Substance Abuse and Mental Health Services Administration, Rockville, MD.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
20 giugno 2019
Completamento primario (Effettivo)
21 maggio 2020
Completamento dello studio (Effettivo)
21 maggio 2020
Date di iscrizione allo studio
Primo inviato
18 giugno 2019
Primo inviato che soddisfa i criteri di controllo qualità
18 giugno 2019
Primo Inserito (Effettivo)
20 giugno 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 agosto 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 agosto 2020
Ultimo verificato
1 agosto 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Disturbi indotti chimicamente
- Malattie dell'apparato digerente
- Processi patologici
- Disturbi Correlati a Sostanze
- Complicanze postoperatorie
- Dolore
- Manifestazioni neurologiche
- Malattie gastrointestinali
- Malattie intestinali
- Disturbi correlati agli stupefacenti
- Dolore, Postoperatorio
- Patologia
- Disturbi correlati agli oppioidi
- Malattie del retto
Altri numeri di identificazione dello studio
- AAAS3302
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
No
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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