Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery

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.

Intervention / Treatment

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

Condition or Disease

  • Colon Cancer
  • Colon Diverticulosis
  • Colonic Neoplasms
  • Colonic Diverticulitis
  • Pain, Postoperative
  • Ileus
  • Ileus Paralytic
  • Ileus; Mechanical
  • Constipation Drug Induced
  • Constipation
  • Rectum Cancer
  • Rectum Neoplasm

Phase

Study Design

Study type: Interventional
Status: Unknown status
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 80 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Jan 17, 2020
Primary Completion: Dec 17, 2020
Completion Date: Dec 18, 2020
Study First Posted: Nov 08, 2016
Results First Posted: Aug 31, 2020
Last Updated: Mar 20, 2017

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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

Sex: All
Minimum Age: 18

More Details

NCT Number: NCT02958566
Other IDs: 825977-4
Study URL: https://ClinicalTrials.gov/show/NCT02958566
Last updated: Jan 27, 2021