Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery

NCT02958566 | Unknown Phase 4 DMC

• 1 other identifier: 825977-4
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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; Ileus; Ileus Paralytic; Ileus; Mechanical; Constipation Drug Induced; Constipation; Rectum Cancer; Rectum Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Length of Hospital Stay

  Total time in hospital from admission to discharge

  30 days

• Days to Return of Bowel Function

  Time from operation to first passage of flatus or bowel movement

  30 days

• Medication cost

  Total cost of inpatient medications

  30 days

• Hospital stay cost

  Total cost of hospital stay

  30 days

Secondary Outcomes (4)

• Amount of narcotics used

  30 days

• Complications

  30 days

• Mortality

  30 days

• Patient satisfaction

  30 days

Study Arms (2)

Narcotic

ACTIVE COMPARATOR

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; Drug: Fentanyl; Drug: Dilaudid; Drug: HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET

Non-Narcotic

EXPERIMENTAL

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; 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

Interventions

Acetaminophen DRUG

Also known as: Tylenol, Ofirmev

Non-Narcotic

Gabapentin DRUG

Also known as: Neurontin

Non-Narcotic

Orphenadrine DRUG

Also known as: Norflex

Non-Narcotic

Lidocaine DRUG

Non-Narcotic

Marcaine DRUG

Non-Narcotic

Ketamine DRUG

Non-Narcotic

Methadone DRUG

Non-Narcotic

Tramadol DRUG

Also known as: Ultram

Non-Narcotic

Ketorolac DRUG

Also known as: Toradol

Non-Narcotic

Morphine Sulfate DRUG

Non-Narcotic

Fentanyl DRUG

Non-Narcotic

Dilaudid DRUG

Non-Narcotic

Hydrocodone-Acetaminophen Tab 5-325 MG DRUG

Also known as: Norco

Non-Narcotic

HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET DRUG

Breakthrough

Also known as: Norco

Narcotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois College of Medicine at Peoria: lead

Study Sites (1)

Uicomp

Peoria, Illinois, 61603, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 19135997 RESULT

• 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.

  PMID: 19535182 RESULT

• Lubawski J, Saclarides T. Postoperative ileus: strategies for reduction. Ther Clin Risk Manag. 2008 Oct;4(5):913-7. doi: 10.2147/tcrm.s2390.

  PMID: 19209273 RESULT

MeSH Terms

Conditions

Colonic Neoplasms; Diverticulosis, Colonic; Diverticulitis, Colonic; Pain, Postoperative; Ileus; Constipation; Rectal Neoplasms; Agnosia

Interventions

Acetaminophen; Gabapentin; Orphenadrine; Lidocaine; Bupivacaine; Ketamine; Methadone; Tramadol; Ketorolac; Ketorolac Tromethamine; Morphine; Fentanyl; Hydromorphone; oxycodone-acetaminophen; Hydrocodone

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Diverticulitis; Diverticular Diseases; Gastroenteritis; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Intestinal Obstruction; Signs and Symptoms, Digestive; Rectal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Ethylamines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Ketones; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Codeine

Study Officials

• Steven S Tsoraides, MD, MPH

  University of Illinois College of Medicine at Peoria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed Almzayyen, MD

CONTACT

mohavt@gmail.com

Marc A Sarran, MD

CONTACT

marc.sarran@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Surgery

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 8, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 20, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)