Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery

March 16, 2017 updated by: Steven Tsoraides, University of Illinois College of Medicine at Peoria

Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery as Part of an Enhanced Recovery After Surgery Protocol: A Randomized Prospective Single- Center Trial.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Peoria, Illinois, United States, 61603
        • Recruiting
        • Uicomp
        • Contact:
          • Steven S Tsoraides, MD/MPH
          • Phone Number: 309-495-0200
          • Email: stsora1@uic.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Fentanyl
Drug: Morphine Sulfate
Drug: Dilaudid
Drug: Morphine Sulfate
PCA
Drug: Fentanyl
PCA
Drug: Dilaudid
PCA
Drug: HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET
Breakthrough
Other Names:
  • 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: Gabapentin
Other Names:
  • Neurontin
Drug: Fentanyl
Drug: Lidocaine
Drug: Ketamine
Drug: Methadone
Drug: Marcaine
Drug: Acetaminophen
Other Names:
  • Tylenol
  • Ofirmev
Drug: Ketorolac
Other Names:
  • Toradol
Drug: Tramadol
Other Names:
  • Ultram
Drug: Morphine Sulfate
Drug: Dilaudid
Drug: Morphine Sulfate
PCA
Drug: Fentanyl
PCA
Drug: Dilaudid
PCA
Drug: Orphenadrine
Other Names:
  • Norflex
Drug: Hydrocodone-Acetaminophen Tab 5-325 MG
Other Names:
  • Norco

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: 30 days
Total time in hospital from admission to discharge
30 days
Days to Return of Bowel Function
Time Frame: 30 days
Time from operation to first passage of flatus or bowel movement
30 days
Medication cost
Time Frame: 30 days
Total cost of inpatient medications
30 days
Hospital stay cost
Time Frame: 30 days
Total cost of hospital stay
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
30 days
Amount of narcotics used
Time Frame: 30 days
Total amount of narcotics patient consumed
30 days
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
30 days
Patient satisfaction
Time Frame: 30 days
Measured using a survey given to patient at discharge
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois College of Medicine at Peoria

Investigators

  • Principal Investigator: Steven S Tsoraides, MD, MPH, University of Illinois College of Medicine at Peoria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 4, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Actual)

March 20, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 825977-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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