Surgical Pain Control With Ropivacaine by Atomized Delivery

Pain Clinical Trial

— SPRAY  

Official title:

Surgical Pain Control With Ropivacaine by Atomized Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480089
• Other study ID #: 203353
• Status: Completed
• Phase: Phase 4
• First received: November 23, 2011
• Last updated: May 6, 2016
• Start date: November 2011
• Est. completion date: February 2013

Study information

• Verified date: May 2016
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

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:
• Atomized Intraperitoneal Saline (AIS)
Atomized saline will be administered to the peritoneal cavity at the completion of surgery.

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-op Pain with Atomized Intraperitoneal Ropivacaine (AIR)	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.	2, 4, 8, 12, 24, and 48 hours after surgery	No
Secondary	Post-op Pain with atomized intraperitoneal saline (AIS)	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.	2, 4, 8, 12, 24, and 48 hours after surgery	No