Clinical trial NCT02958566: Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colon Cancer
Colon Diverticulosis
Colonic Neoplasms
Colonic Diverticulitis
Pain, Postoperative
Ileus
Ileus Paralytic
Ileus; Mechanical
Constipation Drug Induced
Constipation
Rectum Cancer
Rectum Neoplasm
Keywords: Pain control
Post-operative pain
Narcotic
Non-narcotic
Side effect
Toxicity
Lead sponsor: University of Illinois College of Medicine at Peoria
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: 30 days
measure: Days to Return of Bowel Function
timeFrame: 30 days
measure: Medication cost
timeFrame: 30 days
measure: Hospital stay cost
timeFrame: 30 days
Secondary outcomes:
measure: Amount of narcotics used
timeFrame: 30 days
measure: Complications
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: Patient satisfaction
timeFrame: 30 days
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Uicomp
state: Illinois
Study officials:
affiliation: University of Illinois College of Medicine at Peoria
name: Steven S Tsoraides, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Serclova 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.
citation: Lubawski J, Saclarides T. Postoperative ileus: strategies for reduction. Ther Clin Risk Manag. 2008 Oct;4(5):913-7. doi: 10.2147/tcrm.s2390.