Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery
NCT ID: NCT02958566
Last Updated: 2017-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2017-01-31
2018-12-31
Brief Summary
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Detailed Description
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All patients undergoing colorectal surgery require medications for pain control. The mainstay of current treatment includes narcotics/opioids. The effect of these medicines on mu receptors of the intestine contribute to delayed bowel function. Protocols that limit the use of narcotics/opioids may reduce the risk of ileus, thus reducing length of stay and reducing cost.
A prospective randomized clinical trial at a single tertiary referral academic affiliated medical center (OSF St. Francis Medical Center). Patients undergoing minimally invasive (laparoscopic or robotic) colorectal resection will be considered for inclusion. Surgery will be performed by two surgeons participating in the study protocol. Patient accrual is intended to begin May 1, 2016 and terminate either after 80 patients have been accrued or December 31, 2018, whichever is first. Informed consent will be obtained and preoperative education will be provided (appendix A). Patients will be randomized to one of two groups. The randomization scheme is a random-permuted-block design without stratification. The block size is a random number between 4 and 8. Personnel who are unassociated with patient screening, enrollment, or follow-up will create the allocation sequence and will use a computerized, random number generator. The allocation sequence will be transferred to sequentially numbered, opaque envelopes for purposes of allocation concealment. Clinical trial coordinators/physicians will verify patient eligibility and informed consent before opening the envelope to obtain the treatment assignment. The experimental group will be placed on a narcotic limited protocol as described below. All used medications are FDA approved. No investigational medicines will be used.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Narcotic
Morphine, Dilaudid or Fentanyl patient controlled anesthesia (PCA) for the immediate postoperative period, in addition to Norco 5-325 mg 1-2 tabs Q4H PRN, or equivalent medication.
Post-operative day 1: PCA will be discontinued and the patients will have IV narcotics PRN: Morphine 1-2 mg Q2H PRN, fentanyl 50-75 mcg Q2H PRN or Dilaudid 0.5 mg Q2H PRN
Morphine Sulfate
PCA
Fentanyl
PCA
Dilaudid
PCA
HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET
Breakthrough
Non-Narcotic
Gabapentin 300 mg PO, orphenadrine 60 mg IV, acetaminophen 1000 mg PO or IV on Morning of surgery. Lidocaine 100 mg prior to incision, lidocaine 1mg/kg/hour during procedure, marcaine in all incisions. Ketamine and methadone per anesthesia. Acetaminophen 1000 mg PO or IV, gabapentin 300 mg PO, tramadol 50 mg PO in PACU. Acetaminophen 600 mg PO Q 6 hours, tramadol 50 mg PO Q 6 hours, gabapentin 300 mg PO Q 6 hours, orphenadrine 60 mg IV Q 12 hours, ketorolac 15 mg IV Q 6 hours for 48 hours post-operatively.
Acetaminophen
Gabapentin
Orphenadrine
Lidocaine
Marcaine
Ketamine
Methadone
Tramadol
Ketorolac
Morphine Sulfate
Fentanyl
Dilaudid
Hydrocodone-Acetaminophen Tab 5-325 MG
Interventions
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Acetaminophen
Gabapentin
Orphenadrine
Lidocaine
Marcaine
Ketamine
Methadone
Tramadol
Ketorolac
Morphine Sulfate
Fentanyl
Dilaudid
Hydrocodone-Acetaminophen Tab 5-325 MG
Morphine Sulfate
PCA
Fentanyl
PCA
Dilaudid
PCA
HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET
Breakthrough
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients undergoing laparoscopic or robotic colorectal resections
Exclusion Criteria
* Pre-existing use of narcotics or opioids
* Pre-existing renal or hepatic failure
* Mental illness, mental retardation, or inability to participate in informed consent due to mental status
* Pre-existing dementia
* Allergy to any protocol medication
* Emergency operation
* Subjects who are incarcerated or wards of the state
* Minors
* Subjects with inflammatory bowel disease, active colitis, or pre-existing intra-abdominal inflammation. Diverticulitis without active infection/inflammation will not be excluded.
18 Years
ALL
No
Sponsors
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University of Illinois College of Medicine at Peoria
OTHER
Responsible Party
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Steven Tsoraides
Assistant Professor of Clinical Surgery
Principal Investigators
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Steven S Tsoraides, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Illinois College of Medicine at Peoria
Locations
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Uicomp
Peoria, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Muller S, Zalunardo MP, Hubner M, Clavien PA, Demartines N; Zurich Fast Track Study Group. A fast-track program reduces complications and length of hospital stay after open colonic surgery. Gastroenterology. 2009 Mar;136(3):842-7. doi: 10.1053/j.gastro.2008.10.030. Epub 2008 Nov 1.
Serclova Z, Dytrych P, Marvan J, Nova K, Hankeova Z, Ryska O, Slegrova Z, Buresova L, Travnikova L, Antos F. Fast-track in open intestinal surgery: prospective randomized study (Clinical Trials Gov Identifier no. NCT00123456). Clin Nutr. 2009 Dec;28(6):618-24. doi: 10.1016/j.clnu.2009.05.009. Epub 2009 Jun 17.
Lubawski J, Saclarides T. Postoperative ileus: strategies for reduction. Ther Clin Risk Manag. 2008 Oct;4(5):913-7. doi: 10.2147/tcrm.s2390.
Other Identifiers
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825977-4
Identifier Type: -
Identifier Source: org_study_id
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