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

NCT02086123 | Completed

• 1 other identifier: 20118564
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Analgesia; Epidural Analgesia; Narcotic Analgesia; Patient Controlled Analgesia; Anesthesia and Analgesia; Anti inflammatory Analgesics; NSAIDS

Outcome Measures

Primary Outcomes (1)

• Length of Hospital Stay

  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.

  1-7 days

Secondary Outcomes (1)

• Return of bowel function

  1-7 days

Other Outcomes (1)

• Intensity of postoperative pain.

  1-7 days

Study Arms (2)

Epidural Analgesia

ACTIVE COMPARATOR

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

Parenteral Analgesia (Intravenous)

ACTIVE COMPARATOR

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)

Interventions

Epidural Analgesia PROCEDURE

Bupivacaine + Fentanyl

Epidural Analgesia

Parenteral Analgesia (Intravenous) PROCEDURE

Dilaudid 0.2 -0.4 mg IV every 3 hours

Parenteral Analgesia (Intravenous)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (21)

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MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Alessio Pigazzi, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Interim Chair of Surgery

Study Record Dates

• First Submitted: November 20, 2013
• First Posted: March 13, 2014
• Study Start: May 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)