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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|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|
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
- 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.
- 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).
- 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.
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
|United States, California|
|University of California, Irvine Medical Center|
|Orange, California, United States, 92868|
|Principal Investigator:||Alessio Pigazzi, MD||University of California, Irvine|