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