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NCT Number: NCT01480089

Surgical Pain Control With Ropivacaine by Atomized Delivery

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraperitoneal Ropivacaine (AIR)

Drug

Ropivacaine 2 mg/kg per 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 names: Ropivacaine

Atomized Intraperitoneal Saline (AIS)

Drug

Atomized saline will be administered to the peritoneal cavity at the completion of surgery.

Other names: Placebo

Primary outcomes

  1. Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)

    Time frame: 2 hours after surgery

    Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.

Secondary outcomes

  1. Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)

    Time frame: 12 hours after surgery

    Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Acronym: SPRAY

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 28, 2011
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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