Recruiting

Narcotic Limited Pain Control

Sponsor:

University of Illinois College of Medicine at Peoria

Code:

NCT02958566

Conditions

Colon Cancer

Colon Diverticulosis

Colonic Neoplasms

Colonic Diverticulitis

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acetaminophen

Gabapentin

Orphenadrine

Lidocaine

Marcaine

Study Details

Brief 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.

Conditions

Colon Cancer

Colon Diverticulosis

Colonic Neoplasms

Colonic Diverticulitis

Pain, Postoperative

Study ID

NCT02958566

Start date

Jan, 2017

Status verified date

Mar, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males or females above the age of 18
  • Patients undergoing laparoscopic or robotic colorectal resections

Exclusion Criteria:

  • History of constipation
  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: 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

experimental: 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.

Interventions

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

Primary outcome measure

  • Length of Hospital Stay [ Time Frame: 30 days ]
  • Days to Return of Bowel Function [ Time Frame: 30 days ]
  • Medication cost [ Time Frame: 30 days ]
  • Hospital stay cost [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Mohammed Almzayyen, MD

mohavt@gmail.com

Marc A Sarran, MD

marc.sarran@gmail.com

Locations

Uicomp

Recruiting

Peoria, Illinois, United States, 61603

Contacts

Steven S Tsoraides, MD/MPH

309-495-0200stsora1@uic.edu

More Information

Sponsor

University of Illinois College of Medicine at Peoria

Last update posted

Mar 20, 2017

Last verified

Mar, 2017

Keywords

  • Pain control
  • Post-operative pain
  • Narcotic
  • Non-narcotic
  • Side effect
  • Toxicity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Illinois College of Medicine at Peoria on 2017-03-20.