Surgical Pain Control With Ropivacaine by Atomized Delivery (SPRAY)

This study is currently recruiting participants.
Verified October 2012 by Loyola University
Sponsor:
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT01480089
First received: November 23, 2011
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Intraperitoneal Ropivacaine (AIR)
Other: Atomized Intraperitoneal Saline (AIS)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: Surgical Pain Control With Ropivacaine by Atomized Delivery

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Post-op Pain with Atomized Intraperitoneal Ropivacaine (AIR) [ Time Frame: 2, 4, 8, 12, 24, and 48 hours after surgery ] [ Designated as safety issue: No ]
    After the surgery is completed, the participant will be given medications to control pain as needed. The participant will be asked to rate his/her pain level by filling out a questionnaire. The medical record will also be reviewed to collect information regarding the surgery and post-operative care.


Secondary Outcome Measures:
  • Post-op Pain with atomized intraperitoneal saline (AIS) [ Time Frame: 2, 4, 8, 12, 24, and 48 hours after surgery ] [ Designated as safety issue: No ]
    After the surgery is completed, the participant will be given medications to control pain as needed. The participant will be asked to rate his/her pain level by filling out a questionnaire. The medical record will also be reviewed to collect information regarding the surgery and post-operative care.


Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Intraperitoneal Saline (AIS)
Participants randomized to this arm will be given atomized intraperitoneal saline(AIS).
Other: Atomized Intraperitoneal Saline (AIS)
Atomized saline will be administered to the peritoneal cavity at the completion of surgery.
Other Name: Saline
Active Comparator: Intraperitoneal Ropivacaine(AIR)
Participants randomized to this arm will receive atomized intraperitoneal ropivacaine (AIR).
Drug: Intraperitoneal Ropivacaine (AIR)
Ropivacaine 2 mg/kg lean body mass up to no more than 200mg total dose will be atomized and delivered into the peritoneal cavity at the completion of surgery.
Other Name: Ropivacaine

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480089

Contacts
Contact: Elizabeth Mueller, MD 708-216-0342 emuelle@lumc.edu

Locations
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Elizabeth Mueller, MD    708-216-0342    emuelle@lumc.edu   
Principal Investigator: Elizabeth Mueller, MD         
Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Elizabeth Mueller, MD Loyola University
  More Information

No publications provided

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT01480089     History of Changes
Other Study ID Numbers: 203353
Study First Received: November 23, 2011
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Loyola University:
Surgical Pain Management
Robotic surgery
Ropivacaine

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014