Clinical Trial: Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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.

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 Summary:

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 unas
Sponsor: University of Illinois College of Medicine at Peoria

Current Primary Outcome:

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: University of Illinois College of Medicine at Peoria

Dates:
Date Received: November 4, 2016
Date Started: January 2017
Date Completion: December 2018
Last Updated: March 16, 2017
Last Verified: March 2017