Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02958566|
Recruitment Status : Unknown
Verified March 2017 by Steven Tsoraides, OSF Healthcare System.
Recruitment status was: Recruiting
First Posted : November 8, 2016
Last Update Posted : March 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Colon Diverticulosis Colonic Neoplasms Colonic Diverticulitis Pain, Postoperative Ileus Ileus Paralytic Ileus; Mechanical Constipation Drug Induced Constipation Rectum Cancer Rectum Neoplasm||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||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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.|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Narcotic
Morphine, Dilaudid or Fentanyl patient controlled anesthesia (PCA) for the immediate postoperative period, in addition to Norco 5-325 mg 1-2 tabs Q4H PRN, or equivalent medication.
Post-operative day 1: PCA will be discontinued and the patients will have IV narcotics PRN: Morphine 1-2 mg Q2H PRN, fentanyl 50-75 mcg Q2H PRN or Dilaudid 0.5 mg Q2H PRN
Drug: Morphine Sulfate
Drug: HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET
Other Name: Norco
Gabapentin 300 mg PO, orphenadrine 60 mg IV, acetaminophen 1000 mg PO or IV on Morning of surgery. Lidocaine 100 mg prior to incision, lidocaine 1mg/kg/hour during procedure, marcaine in all incisions. Ketamine and methadone per anesthesia. Acetaminophen 1000 mg PO or IV, gabapentin 300 mg PO, tramadol 50 mg PO in PACU. Acetaminophen 600 mg PO Q 6 hours, tramadol 50 mg PO Q 6 hours, gabapentin 300 mg PO Q 6 hours, orphenadrine 60 mg IV Q 12 hours, ketorolac 15 mg IV Q 6 hours for 48 hours post-operatively.
Other Name: Neurontin
Other Name: Norflex
Other Name: Ultram
Other Name: Toradol
Drug: Morphine Sulfate
Drug: Hydrocodone-Acetaminophen Tab 5-325 MG
Other Name: Norco
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958566
|Contact: Mohammed Almzayyen, MDfirstname.lastname@example.org|
|Contact: Marc A Sarran, MDemail@example.com|
|United States, Illinois|
|Peoria, Illinois, United States, 61603|
|Contact: Steven S Tsoraides, MD/MPH 309-495-0200 firstname.lastname@example.org|
|Principal Investigator:||Steven S Tsoraides, MD, MPH||University of Illinois College of Medicine at Peoria|