Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery

University of Illinois College of Medicine at Peoria

Status and phase

Unknown

Phase 4

Conditions

Colon Diverticulosis

Rectum Cancer

Colon Cancer

Pain, Postoperative

Constipation Drug Induced

Ileus; Mechanical

Ileus

Colonic Diverticulitis

Colonic Neoplasms

Constipation

Rectum Neoplasm

Ileus Paralytic

Treatments

Drug: HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET

Drug: Marcaine

Drug: Lidocaine

Drug: Hydrocodone-Acetaminophen Tab 5-325 MG

Drug: Morphine Sulfate

Drug: Dilaudid

Drug: Methadone

Drug: Orphenadrine

Drug: Gabapentin

Drug: Tramadol

Drug: Fentanyl

Drug: Ketorolac

Drug: Acetaminophen

Drug: Ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT02958566

825977-4

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Narcotic

Active Comparator group

Description:

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

Treatment:

Drug: Fentanyl

Drug: Dilaudid

Drug: Morphine Sulfate

Drug: Fentanyl

Drug: Dilaudid

Drug: Morphine Sulfate

Drug: HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET

Non-Narcotic

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl

Drug: Ketorolac

Drug: Acetaminophen

Drug: Marcaine

Drug: Ketamine

Drug: Dilaudid

Drug: Methadone

Drug: Tramadol

Drug: Lidocaine

Drug: Gabapentin

Drug: Morphine Sulfate