Surgical Pain Control With Ropivacaine by Atomized Delivery (SPRAY)

Loyola University

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Intraperitoneal Ropivacaine (AIR); Drug: Atomized Intraperitoneal Saline (AIS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01480089

203353

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

Atomized Intraperitoneal Saline (AIS)

Placebo Comparator group

Description:

Participants randomized to this arm will be given atomized intraperitoneal saline(AIS).

Treatment:

Drug: Atomized Intraperitoneal Saline (AIS)

Intraperitoneal Ropivacaine(AIR)

Active Comparator group

Description:

Participants randomized to this arm will receive atomized intraperitoneal ropivacaine (AIR).

Treatment:

Drug: Intraperitoneal Ropivacaine (AIR)