Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02958566
• Other study ID #: 825977-4
• Status: Recruiting
• Phase: Phase 4
• First received: November 4, 2016
• Last updated: March 16, 2017
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: University of Illinois College of Medicine at Peoria
• Contact: Mohammed Almzayyen, MD
• Email: mohavt[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Acetaminophen

• Gabapentin

• Orphenadrine

• Lidocaine

• Marcaine

• Ketamine

• Methadone

• Tramadol

• Ketorolac

• Morphine Sulfate

• Fentanyl

• Dilaudid

• Hydrocodone-Acetaminophen Tab 5-325 MG

• Morphine Sulfate
PCA
• Fentanyl
PCA
• Dilaudid
PCA
• HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET
Breakthrough

Locations

Country	Name	City	State
United States	Uicomp	Peoria	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois College of Medicine at Peoria

Country where clinical trial is conducted

United States, 

References & Publications (3)

Lubawski J, Saclarides T. Postoperative ileus: strategies for reduction. Ther Clin Risk Manag. 2008 Oct;4(5):913-7. — View 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.2 — View Citation

Serclová Z, Dytrych P, Marvan J, Nová K, Hankeová Z, Ryska O, Slégrová Z, Buresová L, Trávníková L, Antos F. Fast-track in open intestinal surgery: prospective randomized study (Clinical Trials Gov Identifier no. NCT00123456). Clin Nutr. 2009 Dec;28(6):61 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Hospital Stay	Total time in hospital from admission to discharge	30 days
Primary	Days to Return of Bowel Function	Time from operation to first passage of flatus or bowel movement	30 days
Primary	Medication cost	Total cost of inpatient medications	30 days
Primary	Hospital stay cost	Total cost of hospital stay	30 days
Secondary	Amount of narcotics used	Total amount of narcotics patient consumed	30 days
Secondary	Complications	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	30 days
Secondary	Mortality		30 days
Secondary	Patient satisfaction	Measured using a survey given to patient at discharge	30 days