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Nonsteroidal Anti-inflammatory Drug (NSAID)
Non-Narcotic for Paralytic Ileus
Phase 4
Waitlist Available
Led By Steven S Tsoraides, MD, MPH
Research Sponsored by University of Illinois College of Medicine at Peoria
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males or females above the age of 18
Patients undergoing laparoscopic or robotic colorectal resections
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
The General Objective of this study is to investigate the cost and efficacy of treating patients undergoing colorectal surgical resections with an opioid limited pain control regimen as part of an Enhanced Recovery After Surgery (ERAS) Protocol. This group will be compared to a traditional opioid based pain control regimen.
Eligible Conditions
- Paralytic Ileus
- Postoperative Pain
- Rectal Cancer
- Intestinal Obstruction
- Constipation
- Mechanical Ileus
- Diverticulitis
- Colorectal Cancer
- Colon Cancer
- Diverticulosis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Days to Return of Bowel Function
Hospital stay cost
Length of Hospital Stay
+1 moreSecondary outcome measures
Narcotics
Complications
Mortality
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Non-NarcoticExperimental Treatment13 Interventions
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.
Group II: NarcoticActive Control4 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen
FDA approved
Gabapentin
FDA approved
Orphenadrine
FDA approved
Lidocaine
FDA approved
Bupivacaine
FDA approved
Ketamine
FDA approved
Methadone
FDA approved
Tramadol
FDA approved
Ketorolac
FDA approved
Morphine
FDA approved
Fentanyl
FDA approved
Find a Location
Who is running the clinical trial?
University of Illinois College of Medicine at PeoriaLead Sponsor
14 Previous Clinical Trials
11,731 Total Patients Enrolled
Steven S Tsoraides, MD, MPHPrincipal InvestigatorUniversity of Illinois College of Medicine at Peoria
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