Status:
COMPLETED
Impact of Intraperitonael Nebulization of Local Anesthetic on Postoperative Pain Associated With Laparoscopic Surgery
Lead Sponsor:
San Gerardo Hospital
Conditions:
Gynecologic Laparoscopic Surgery
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 as...
Detailed Description
Studies evaluating intraperitoneal local anesthetic (LA) instillation for pain relief after laparoscopic surgery have provided conflicting results. One of the factors that might contribute to failure ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01512914
Start Date
May 1 2008
End Date
September 1 2009
Last Update
January 19 2012
Active Locations (1)
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1
San Gerardo Hospital
Monza, MB, Italy, 20052