Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery

Study Overview
=================
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.

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.

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.

Conditions
-----------------
Ileus, Colon Cancer, Colon Diverticulosis, Colonic Neoplasms, Colonic Diverticulitis, Pain, Postoperative, Ileus Paralytic, Ileus; Mechanical, Constipation Drug Induced, Constipation, Rectum Cancer, Rectum Neoplasm

Intervention / Treatment
-----------------
* 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: Morphine Sulfate
* Drug: Fentanyl
* Drug: Dilaudid
* Drug: HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Narcotic<br>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<br>* PCA<br>Drug: Fentanyl<br>* PCA<br>Drug: Dilaudid<br>* PCA<br>Drug: HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET<br>* Breakthrough<br>* Other names: Norco;|
| Experimental: Non-Narcotic<br>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<br> <br> * Other names: Ofirmev;Drug: Gabapentin<br> <br> * Other names: Neurontin;Drug: Orphenadrine<br> <br> * Other names: Norflex;Drug: Lidocaine<br> <br> Drug: Marcaine<br> <br> Drug: Ketamine<br> <br> Drug: Methadone<br> <br> Drug: Tramadol<br> <br> * Other names: Ultram;Drug: Ketorolac<br> <br> * Other names: Toradol;Drug: Morphine Sulfate<br> <br> Drug: Fentanyl<br> <br> Drug: Dilaudid<br> <br> Drug: Hydrocodone-Acetaminophen Tab 5-325 MG<br> <br> * Other names: Norco;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain control, Post-operative pain, Narcotic, Non-narcotic, Side effect, Toxicity