Impact of Intraperitonael Nebulization of Local Anesthetic on Postoperative Pain Associated With Laparoscopic Surgery

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Studies evaluating intraperitoneal local anesthetic instillation for pain relief after laparoscopic procedures have provided conflicting results. This randomized, double-blind study was designed to assess the effects of a novel intraperitoneal local anesthetic administration technique using nebulization on pain relief after gynecologic laparoscopic surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: San Gerardo Hospital
• Treatments: Anesthetics; Anesthetics, Local; Ropivacaine

Criteria

Inclusion Criteria:

• Females 18-70 years old, ASA score 1 - 3;

• scheduled for laparoscopic operative surgery in the Obstetrics and Gynecology unit;

• free from pain in preoperative period, without habitual analgesic use;

• without cognitive impairment or mental retardation, who gave a written informed consent

Exclusion Criteria:

• Females under 18 or over 70;

• ASA 4 or 5;

• emergency/urgency criteria, postoperative admission in a intensive care unit with sedation or ventilatory assistance; cognitive impairment or mental retardation;

• habitual analgesic use; progressive degenerative diseases of the CNS;

• convulsions or chronic therapy with antiepileptic drugs;

• severe hepatic or renal impairment;

• pregnancy or lactation;

• allergy to one of the specific substances used in the study;

• acute infectious disease or inflammatory chronic disease, alcohol or drug addiction;

• any kind of communication problem;

• neurologic or psychiatric disease;

• no written informed consent