Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery

Sponsor

University of Illinois College of Medicine at Peoria (Other)

Overall Status

Unknown status

CT.gov ID

NCT02958566

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer Colon Diverticulosis Colonic Neoplasms Colonic Diverticulitis Pain, Postoperative Ileus Ileus Paralytic Ileus; Mechanical Constipation Drug Induced Constipation Rectum Cancer Rectum Neoplasm	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	Phase 4

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

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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.

Actual Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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: 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: Acetaminophen Other Names: Tylenol Ofirmev Drug: Gabapentin Other Names: Neurontin Drug: Orphenadrine Other Names: Norflex Drug: Lidocaine Drug: Marcaine Drug: Ketamine Drug: Methadone Drug: Tramadol Other Names: Ultram Drug: Ketorolac Other Names: Toradol Drug: Morphine Sulfate Drug: Fentanyl Drug: Dilaudid Drug: Hydrocodone-Acetaminophen Tab 5-325 MG Other Names: Norco

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: 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: Acetaminophen

Other Names:

Tylenol

Ofirmev

Drug: Gabapentin

Other Names:

Neurontin

Drug: Orphenadrine

Other Names:

Norflex

Drug: Lidocaine

Drug: Marcaine

Drug: Ketamine

Drug: Methadone

Drug: Tramadol

Other Names:

Ultram

Drug: Ketorolac

Other Names:

Toradol

Drug: Morphine Sulfate

Drug: Fentanyl

Drug: Dilaudid

Drug: Hydrocodone-Acetaminophen Tab 5-325 MG

Other Names:

Norco

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Amount of narcotics used [30 days]
Total amount of narcotics patient consumed
Complications [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
Mortality [30 days]
Patient satisfaction [30 days]
Measured using a survey given to patient at discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.