Ignite Creation Date:
2024-05-06 @ 12:06 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01480089
Status:
COMPLETED
Last Update Posted:
2016-07-27
First Post:
2011-11-23
Brief Title:
Surgical Pain Control With Ropivacaine by Atomized Delivery
Sponsor:
Loyola University
Organization:
Loyola University
Study Overview
Official Title:
Surgical Pain Control With Ropivacaine by Atomized Delivery
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
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:
SPRAY
Brief Summary:
The purpose of this trial is to determine the effect of spraying a local anesthetic called Ropivacaine numbing medicine into the abdominal cavity prior to surgery Ropivacaine is a local anesthetic used to block pain in the body There are studies showing that Ropivacaine decreases the pain of surgery with minimally invasive laparoscopic appendix and gallbladder removal but has not been tried in robotic pelvic surgery
Detailed Description:
Practice guidelines from the American Society of Anesthesiologists peri-operative techniques for pain management have remained essentially unchanged over the last 10 years 3 Current acute pain-management strategies include 1 Epidural or intrathecal opioids 2 Patient-controlled devices delivering systemic opioids and 3 Regional techniques such as peripheral nerve blocks and post-incisional infiltration with local anesthetics
The use of epidural and systemic opioids results in significant side-effects such as post-operative nausea and ileus which often lead to increased hospital stay The literature supporting the benefit of preincisional infiltration with anesthetics remains equivocal
A recently published study describes the use of intraperitoneal Ropivacaine 2mhkg during laparoscopic appendectomy4 The study was a randomized double-blinded placebo-controlled study using Ropivacaine vs placebo injected through the laparoscopic ports prior to the start of the appendectomy in 63 patients4
Patients treated with Ropivacaine had a significant decrease in visual analog pain scores post-operatively and had decreased narcotic use during their hospital stay compared to placebo There were no side-effects found with the one-time use of the Ropivacaine
The results of the above study and review of an additional 24 randomized controlled trials conducted from 1993-2003 are not felt to be generalizable to pelvic surgery where port placement and the operative procedures vary significantly Hence this study was undertaken to investigate the role of intraperitoneal Ropivacaine as an adjuvant to muscle relaxants and narcotics at the time of pelvic surgery
The use of epidural and systemic opioids results in significant side-effects such as post-operative nausea and ileus which often lead to increased hospital stay The literature supporting the benefit of preincisional infiltration with anesthetics remains equivocal
A recently published study describes the use of intraperitoneal Ropivacaine 2mhkg during laparoscopic appendectomy4 The study was a randomized double-blinded placebo-controlled study using Ropivacaine vs placebo injected through the laparoscopic ports prior to the start of the appendectomy in 63 patients4
Patients treated with Ropivacaine had a significant decrease in visual analog pain scores post-operatively and had decreased narcotic use during their hospital stay compared to placebo There were no side-effects found with the one-time use of the Ropivacaine
The results of the above study and review of an additional 24 randomized controlled trials conducted from 1993-2003 are not felt to be generalizable to pelvic surgery where port placement and the operative procedures vary significantly Hence this study was undertaken to investigate the role of intraperitoneal Ropivacaine as an adjuvant to muscle relaxants and narcotics at the time of pelvic surgery
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