Pain, Postoperative Clinical Trial
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.
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.
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