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Surgical Pain Control With Ropivacaine by Atomized Delivery

Information source: Loyola University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Intraperitoneal Ropivacaine (AIR) (Drug); Atomized Intraperitoneal Saline (AIS) (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: Loyola University

Official(s) and/or principal investigator(s):
Elizabeth Mueller, MD, Principal Investigator, Affiliation: Loyola University

Overall contact:
Elizabeth Mueller, MD, Phone: 708-216-0342, Email: emuelle@lumc.edu


The purpose of this research is to find out the good and bad effects 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.

Clinical Details

Official title: Surgical Pain Control With Ropivacaine by Atomized Delivery

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Primary outcome: Post-op Pain with Atomized Intraperitoneal Ropivacaine (AIR)

Secondary outcome: Post-op Pain with atomized intraperitoneal saline (AIS)

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 (2mh/kg) during laparoscopic appendectomy(4). 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 patients(4). 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.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- Consent to undergo robotic assisted gynecologic or urologic surgery

- Between the ages of 18 and 75

- Able to consent, fill out study documents, and complete all study procedures and

follow-up visits Exclusion Criteria:

- Patients with an allergy to local anesthetics

- Patients with severe underlying cardiovascular, renal or hepatic disease

- Pregnant patients

Locations and Contacts

Elizabeth Mueller, MD, Phone: 708-216-0342, Email: emuelle@lumc.edu

Loyola University Medical Center, Maywood, Illinois 60153, United States; Recruiting
Elizabeth Mueller, MD, Phone: 708-216-0342, Email: emuelle@lumc.edu
Elizabeth Mueller, MD, Principal Investigator
Additional Information

Starting date: November 2011
Last updated: August 10, 2015

Page last updated: August 23, 2015

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