A Phase 4 interventional study of Acetaminophen and Gabapentin in Colon Cancer, Colon Diverticulosis and Colonic Neoplasms, sponsored by University of Illinois College of Medicine at Peoria. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-20.
Sponsored by University of Illinois College of Medicine at Peoria · Phase 4, Interventional, and Supportive care
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.
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.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's planned enrollment of 80 is close to the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →University of Illinois College of Medicine at Peoria is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Also known as: Tylenol, Ofirmev
Also known as: Neurontin
Also known as: Norflex
Also known as: Ultram
Also known as: Toradol
Drug pages: Hydrocodone · Acetaminophen
Also known as: Norco
PCA
PCA
PCA
Breakthrough
Also known as: Norco
Length of Hospital Stay
Total time in hospital from admission to discharge
Time frame: 30 days
Days to Return of Bowel Function
Time from operation to first passage of flatus or bowel movement
Time frame: 30 days
Medication cost
Total cost of inpatient medications
Time frame: 30 days
Hospital stay cost
Total cost of hospital stay
Time frame: 30 days
Amount of narcotics used
Total amount of narcotics patient consumed
Time frame: 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
Time frame: 30 days
Mortality
Time frame: 30 days
Patient satisfaction
Measured using a survey given to patient at discharge
Time frame: 30 days
Plan to share: No
This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Acetaminophen · Gabapentin · Orphenadrine · Lidocaine · Bupivacaine · Ketamine · Methadone · Tramadol · Ketorolac · Hydrocodone
University of Illinois College of Medicine at Peoria