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Randomized Study Comparing the Use of Epidural Analgesia to Intravenous Narcotics for Laparoscopic Colorectal Resection.

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ClinicalTrials.gov Identifier: NCT02086123
Recruitment Status : Unknown
Verified November 2014 by Alessio Pigazzi, University of California, Irvine.
Recruitment status was:  Active, not recruiting
First Posted : March 13, 2014
Last Update Posted : November 10, 2014
Sponsor:
Information provided by (Responsible Party):
Alessio Pigazzi, University of California, Irvine

Brief Summary:

Laparoscopic colorectal surgery (LCS) has gained wide acceptance in the treatment of various pathology from diverticular disease to colon cancer. In comparison to conventional open surgery LCS has the benefits of shorter hospital stay, reduced postoperative pain, lower wound-related complication rates, better cosmetic results and earlier return to normal activities.

Despite the fact that laparoscopic colorectal surgery is done through smaller incisions, there is still a considerable amount of abdominal wall trauma with these procedures. This still can cause a significant amount of postoperative discomfort, which can add to patients' stress, decreased satisfaction, and prolong length of hospital stay. Postoperative pain can be difficult to control and has been mainly managed pharmacologically with the use of narcotics and non-narcotic medications delivered through different routes. The effectiveness of pain control depends on the medication, its dosage, frequency and route of administration. The latter is mainly achieved through the intravenous route in the immediate postoperative period in laparoscopic colorectal surgery patient, as patients are restricted from having anything by mouth until return of bowel function.

Another route of delivery is the use of local anesthetics as well as opioids via an epidural catheter. Epidural analgesia (EA) has the potential to offer excellent pain control and decrease the rate of postoperative ileus. Despite the extensive use of epidural anesthesia in obstetrics, to date there has been very few studies looking at the effectiveness of epidural analgesia in laparoscopic colorectal surgery.

The primary purpose of this study is to evaluate the impact of epidural analgesia as compared to conventional analgesia on the length of hospital stay in patients undergoing laparoscopic colorectal procedures. The secondary objectives of the study will be to evaluate patient satisfaction, quality of life, pain control and return of bowel function in patients treated with either epidural analgesia or intravenous narcotics.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Epidural Analgesia Procedure: Parenteral Analgesia (Intravenous) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Clinical Trial Comparing the Use of Perioperative Epidural Analgesia to Conventional Intravenous Narcotics and NSAIDS for Patients Undergoing Laparoscopic Colorectal Resection
Study Start Date : May 2012
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Epidural Analgesia
Subjects randomized to this arm will receive Bupivacaine + Fentanyl Epidural Analgesia. Subjects on this group could be allowed to receive Toradol Intravenously (IV) + Acetaminophen Orally (PO) if needed.
Procedure: Epidural Analgesia
Bupivacaine + Fentanyl

Active Comparator: Parenteral Analgesia (Intravenous)
Subjects randomized to this arm will receive Analgesia with Dilaudid 0.2 -0.4 mg Intravenously (IV) every 3 hours. Subjects on this group could be allowed to receive Toradol Intravenously (IV) + Acetaminophen Orally (PO) if needed.
Procedure: Parenteral Analgesia (Intravenous)
Dilaudid 0.2 -0.4 mg IV every 3 hours




Primary Outcome Measures :
  1. Length of Hospital Stay [ Time Frame: 1-7 days ]
    The primary end point of the analyses is length of hospital stay from the date of admission for the surgical procedure to the day of hospital discharge.


Secondary Outcome Measures :
  1. Return of bowel function [ Time Frame: 1-7 days ]
    The secondary outcome is to measure the length of time in days from the day of the surgical procedure to the time of return of bowel function (passage of flatus and bowel movements).


Other Outcome Measures:
  1. Intensity of postoperative pain. [ Time Frame: 1-7 days ]
    Other secondary objective of the study is to evaluate the intensity of postoperative pain measured by the visual analog scale. This objective will be evaluated applying a daily questionnaire to the patients asking about their level of pain.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Subjects undergoing laparoscopic large bowel resection or rectal resection with anastomosis and/ or any type of ostomy (end, diverting)
  • University of California, Irvine Medical Center inpatients and outpatients scheduled for surgery
  • Elective surgery for benign and malignant conditions

Exclusion Criteria:

  • Emergency procedure including procedures done for bowel obstruction, constriction, fulminant inflammation
  • Infection
  • Patient participating in other trials that may affect the study outcome
  • Subjects with hypersensitivity to any of the anesthesia drugs used per Standard of Care at UCI Medical Center
  • Subjects with history of chronic pain
  • Pregnant patients or nursing females
  • Subjects with a history of severe cardiovascular, pulmonary, renal, hepatic, hematologic or systemic disease
  • Early Study Termination due to conversion to Open Surgery (subjects who were converted from laparoscopic to open surgery
  • Contraindication to epidural anesthesia (bleeding diathesis, severe hypovolemia, elevated intracranial pressure, infection at the site of injection, and severe stenotic valvular heart disease or ventricular outflow obstruction.

Information from the National Library of Medicine

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): NCT02086123


Locations
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United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Alessio Pigazzi, MD University of California, Irvine
Publications:

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Responsible Party: Alessio Pigazzi, Associate Clinical Professor of Surgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02086123    
Other Study ID Numbers: HS#2011-8564
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014
Keywords provided by Alessio Pigazzi, University of California, Irvine:
Analgesia
Epidural Analgesia
Narcotic Analgesia
Patient Controlled Analgesia
Anesthesia and Analgesia
Anti inflammatory Analgesics
NSAIDS
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations