Surgical Pain Control With Ropivacaine by Atomized Delivery

Phase 4

Completed

Conditions: Pain

Interventions: Drug: Atomized Intraperitoneal Saline (AIS)
Drug: Intraperitoneal Ropivacaine (AIR)

Registration Number: NCT01480089

Lead Sponsor: Loyola University

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 56

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atomized Intraperitoneal Saline (AIS)	Atomized Intraperitoneal Saline (AIS)	Participants randomized to this arm will be given atomized intraperitoneal saline(AIS).
Intraperitoneal Ropivacaine(AIR)	Intraperitoneal Ropivacaine (AIR)	Participants randomized to this arm will receive atomized intraperitoneal ropivacaine (AIR).

Primary Outcome Measures

Name	Time	Method
Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)	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 Outcome Measures

Name	Time	Method
Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)	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.