Viewing Study NCT01552226



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Last Modification Date: 2024-10-26 @ 10:48 AM
Study NCT ID: NCT01552226
Status: UNKNOWN
Last Update Posted: 2014-07-23
First Post: 2012-02-28

Brief Title: Compare Preperitoneal Analgesia to Epidural Analgesia for Pain Control After Colon and Rectal Surgery
Sponsor: Saint Joseph Mercy Health System
Organization: Saint Joseph Mercy Health System

Study Overview

Official Title: Prospective Randomized Clinical Trial to Compare Continuous Preperitoneal Analgesia to Continuous Epidural Analgesia for Pain Control After Colon and Rectal Surgery
Status: UNKNOWN
Status Verified Date: 2014-07
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a prospective randomized study of 114 patients The purpose of this study is to compare the efficacy of two standard methods of analgesia for pain control in patients undergoing elective colon and rectal surgery as measured by the Numeric Pain Scale NPS and by the need for supplemental narcotic analgesics This study is designed to determine if postoperative pain control by local analgesics delivered through preperitoneally placed ON-Q Silver SoakerTM catheters CPA is equivalent to continuous epidural analgesia CEA
Detailed Description: Background Perioperative analgesia is a vital part of the management of patients undergoing colon and rectal surgery affecting well being and length of hospital stay Neuraxial anesthetics infused through epidural or spinal catheters have become commonplace pain management agents for patients These techniques however are labor-intensive and expensive Alternatively local analgesics may be administered directly to the surgical wound via silver catheters

Aim Two standard methods of analgesia for pain control for colon and rectal surgery will be evaluated systematically to determine if these two approaches are equivalent in terms of patient pain scores and supplemental narcotic use

Study Design This is a prospective randomized study of 114 participants undergoing elective colon and rectal surgery at an independent academic medical center The primary outcomes are post-operative pain control and supplemental narcotic usage

Other variables of interest

Surgical site infections
The post-operative time to return of bowel function
The hospital expensescost differences
Quality of life measured with the SF- 36 questionnaire

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None