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Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT02958566
Recruitment Status : Unknown
Verified March 2017 by Steven Tsoraides, OSF Healthcare System.
Recruitment status was:  Recruiting
First Posted : November 8, 2016
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Steven Tsoraides, OSF Healthcare System

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Colon Diverticulosis Colonic Neoplasms Colonic Diverticulitis Pain, Postoperative Ileus Ileus Paralytic Ileus; Mechanical Constipation Drug Induced Constipation Rectum Cancer Rectum Neoplasm Drug: Acetaminophen Drug: Gabapentin Drug: Orphenadrine Drug: Lidocaine Drug: Marcaine Drug: Ketamine Drug: Methadone Drug: Tramadol Drug: Ketorolac Drug: Morphine Sulfate Drug: Fentanyl Drug: Dilaudid Drug: Hydrocodone-Acetaminophen Tab 5-325 MG Drug: HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET Phase 4

Detailed Description:

Postoperative ileus is a well-known problem for patients who have undergone a colorectal procedure. It is manifested as abdominal distension, accumulation of gas and fluid within the bowels and delayed bowel function (flatus or defecation). It is estimated that with traditional perioperative care for open colon resection postoperative ileus can lead to a length of stay (LOS) of 10 days. Such factors include the use of narcotics, immobilization, over-hydration with IV fluid etc. With about 350,000 colon and small bowel resections occurring annually and a bill to the healthcare system greater than US $20 billion, even decreasing LOS by one or two days can result in substantial cost savings.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery as Part of an Enhanced Recovery After Surgery Protocol: A Randomized Prospective Single- Center Trial.
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Drug: Morphine Sulfate
PCA

Drug: Fentanyl
PCA

Drug: Dilaudid
PCA

Drug: HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET
Breakthrough
Other Name: Norco

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.
Drug: Acetaminophen
Other Names:
  • Tylenol
  • Ofirmev

Drug: Gabapentin
Other Name: Neurontin

Drug: Orphenadrine
Other Name: Norflex

Drug: Lidocaine
Drug: Marcaine
Drug: Ketamine
Drug: Methadone
Drug: Tramadol
Other Name: Ultram

Drug: Ketorolac
Other Name: Toradol

Drug: Morphine Sulfate
Drug: Fentanyl
Drug: Dilaudid
Drug: Hydrocodone-Acetaminophen Tab 5-325 MG
Other Name: Norco




Primary Outcome Measures :
  1. Length of Hospital Stay [ Time Frame: 30 days ]
    Total time in hospital from admission to discharge

  2. Days to Return of Bowel Function [ Time Frame: 30 days ]
    Time from operation to first passage of flatus or bowel movement

  3. Medication cost [ Time Frame: 30 days ]
    Total cost of inpatient medications

  4. Hospital stay cost [ Time Frame: 30 days ]
    Total cost of hospital stay


Secondary Outcome Measures :
  1. Amount of narcotics used [ Time Frame: 30 days ]
    Total amount of narcotics patient consumed

  2. Complications [ Time Frame: 30 days ]
    Death, prolonged ileus (insertion of NG tube or lack of bowel function on POD 3), respiratory failure, renal failure, SSI, leak, pneumonia, UTI, DVT/PE, cardiac event/MI

  3. Mortality [ Time Frame: 30 days ]
  4. Patient satisfaction [ Time Frame: 30 days ]
    Measured using a survey given to patient at discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958566


Contacts
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Contact: Mohammed Almzayyen, MD mohavt@gmail.com
Contact: Marc A Sarran, MD marc.sarran@gmail.com

Locations
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United States, Illinois
Uicomp Recruiting
Peoria, Illinois, United States, 61603
Contact: Steven S Tsoraides, MD/MPH    309-495-0200    stsora1@uic.edu   
Sponsors and Collaborators
University of Illinois College of Medicine at Peoria
Investigators
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Principal Investigator: Steven S Tsoraides, MD, MPH University of Illinois College of Medicine at Peoria

Publications of Results:
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Responsible Party: Steven Tsoraides, Assistant Professor of Clinical Surgery, OSF Healthcare System
ClinicalTrials.gov Identifier: NCT02958566     History of Changes
Other Study ID Numbers: 825977-4
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Steven Tsoraides, OSF Healthcare System:
Pain control
Post-operative pain
Narcotic
Non-narcotic
Side effect
Toxicity
Additional relevant MeSH terms:
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Diverticulitis
Diverticulum
Diverticulitis, Colonic
Colonic Neoplasms
Rectal Neoplasms
Ileus
Constipation
Pain, Postoperative
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Intestinal Obstruction
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Rectal Diseases