Colon CancerPhase 4NCT02958566
Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery
A Phase 4 study testing Acetaminophen, Gabapentin and Orphenadrine in people with Colon Cancer and Colon Diverticulosis, run by University of Illinois College of Medicine at Peoria at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Colon Diverticulosis, Colonic Neoplasms
- What is being tested?
- Acetaminophen, Gabapentin and Orphenadrine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females above the age of 18
- Patients undergoing laparoscopic or robotic colorectal resections
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Mohammed Almzayyen, MD contact
Marc A Sarran, MD contact
United States1 site, 1 recruiting
- Recruiting
Uicomp
Peoria, Illinois, 61603
Steven S Tsoraides, MD/MPH, 309-495-0200, stsora1@uic.edu
About this study
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.
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.
Read the 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.
- Conditions
- Colon Cancer, Colon Diverticulosis, Colonic Neoplasms, Colonic Diverticulitis, Pain, Postoperative, Ileus
- Being tested
- Acetaminophen, Gabapentin, Orphenadrine, Lidocaine, Marcaine
- Keywords
- Pain control, Post-operative pain, Narcotic, Non-narcotic, Side effect, Toxicity
- Medical subject headings
- Colonic Neoplasms, Diverticulosis, Colonic, Diverticulitis, Colonic, Pain, Postoperative, Ileus, Constipation, Rectal Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Tylenol, Ofirmev
GabapentinDrug
Also called Neurontin
OrphenadrineDrug
Also called Norflex
LidocaineDrug
MarcaineDrug
KetamineDrug
MethadoneDrug
TramadolDrug
Also called Ultram
KetorolacDrug
Also called Toradol
Morphine SulfateDrug
FentanylDrug
DilaudidDrug
Hydrocodone-Acetaminophen Tab 5-325 MGDrug
Also called Norco
Morphine SulfateDrug
PCA
FentanylDrug
PCA
DilaudidDrug
PCA
HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLETDrug
Also called Norco
Breakthrough
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
Total time in hospital from admission to discharge
Measured: 30 days
Days to Return of Bowel Function
Time from operation to first passage of flatus or bowel movement
Measured: 30 days
Medication cost
Total cost of inpatient medications
Measured: 30 days
Hospital stay cost
Total cost of hospital stay
Measured: 30 days
Secondary outcomes (4)
Amount of narcotics used
Total amount of narcotics patient consumed
Measured: 30 days
Complications
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
Measured: 30 days
Mortality
Measured: 30 days
Patient satisfaction
Measured using a survey given to patient at discharge
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois College of Medicine at Peoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Tsoraides, OSF Healthcare System
- Investigators
- Steven S Tsoraides, MD, MPH, Principal investigator, University of Illinois College of Medicine at Peoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958566
- Sponsor's protocol ID
- 825977-4
- Status last verified
- Mar 2017
- First submitted
- 4 Nov 2016
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 19135997Serclova 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.
PubMed 19535182Lubawski J, Saclarides T. Postoperative ileus: strategies for reduction. Ther Clin Risk Manag. 2008 Oct;4(5):913-7. doi: 10.2147/tcrm.s2390.
PubMed 19209273
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02958566
- Acronym / sponsor ID
- 825977-4
- Conditions
- Colon Cancer, Colon Diverticulosis, Colonic Neoplasms, Colonic Diverticulitis, Pain, Postoperative, Ileus
- Keywords
- Pain control, Post-operative pain, Narcotic, Non-narcotic, Side effect, Toxicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Illinois College of Medicine at PeoriaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narcotic | Active comparator | Drug: Morphine Sulfate, Drug: Fentanyl, Drug: Dilaudid, Drug: HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLETMorphine, 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 |
| Non-Narcotic | Experimental | 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 MGGabapentin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males or females above the age of 18
- Patients undergoing laparoscopic or robotic colorectal resections
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenAlso: Tylenol, Ofirmev | Drug | Non-Narcotic |
| GabapentinAlso: Neurontin | Drug | Non-Narcotic |
| OrphenadrineAlso: Norflex | Drug | Non-Narcotic |
| Lidocaine | Drug | Non-Narcotic |
| Marcaine | Drug | Non-Narcotic |
| Ketamine | Drug | Non-Narcotic |
| Methadone | Drug | Non-Narcotic |
| TramadolAlso: Ultram | Drug | Non-Narcotic |
| KetorolacAlso: Toradol | Drug | Non-Narcotic |
| Morphine Sulfate | Drug | Non-Narcotic |
| Fentanyl | Drug | Non-Narcotic |
| Dilaudid | Drug | Non-Narcotic |
| Hydrocodone-Acetaminophen Tab 5-325 MGAlso: Norco | Drug | Non-Narcotic |
| Morphine SulfatePCA | Drug | Narcotic |
| FentanylPCA | Drug | Narcotic |
| DilaudidPCA | Drug | Narcotic |
| HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLETAlso: NorcoBreakthrough | Drug | Narcotic |
Primary outcome
Length of Hospital Stay
Time frame: 30 days
Total time in hospital from admission to discharge
Days to Return of Bowel Function
Time frame: 30 days
Time from operation to first passage of flatus or bowel movement
Medication cost
Time frame: 30 days
Total cost of inpatient medications
Hospital stay cost
Time frame: 30 days
Total cost of hospital stay
4 secondary outcomes
Amount of narcotics used
Time frame: 30 days
Complications
Time frame: 30 days
Mortality
Time frame: 30 days
Patient satisfaction
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Results publication: PubMed 19135997Muller 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.
- Results publication: PubMed 19535182Serclova 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.
- Results publication: PubMed 19209273Lubawski J, Saclarides T. Postoperative ileus: strategies for reduction. Ther Clin Risk Manag. 2008 Oct;4(5):913-7. doi: 10.2147/tcrm.s2390.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Almzayyen, MD contact
Marc A Sarran, MD contact
Steven S Tsoraides, MD, MPH principal investigator
University of Illinois College of Medicine at Peoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen, Gabapentin and Orphenadrine in people with Colon Cancer and Colon Diverticulosis, run by University of Illinois College of Medicine at Peoria at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Almzayyen, MD (mohavt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02958566, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.