CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 87 enrolled
Drug / intervention
Epidural Analgesia +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02086123
NCT02086123N/ACompleted

Randomized Clinical Trial Comparing the Use of Perioperative Epidural Analgesia to Conventional Intravenous Narcotics and NSAIDS for Patients Undergoing Laparoscopic Colorectal Resection

University of California, Irvine·interventional·Posted Mar 13, 2014·Updated Aug 14, 2023

In Brief

A clinical study evaluating Epidural Analgesia and Parenteral Analgesia (Intravenous) for Pain, Postoperative. Completed, enrolled 87 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 13, 2014
Enrollment StartMay 1, 2012
Primary CompletionMar 1, 2015
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.3 years ago

Interventions

Epidural Analgesiaprocedure

Bupivacaine + Fentanyl

Parenteral Analgesia (Intravenous)procedure

Dilaudid 0.2 -0.4 mg IV every 3 hours