Overview

Local Anesthetic Nebulization and Instillation for Pain Control After Laparoscopic Surgery

Status:
Completed
Trial end date:
2009-05-01
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 laparoscopic cholecystectomy.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
San Gerardo Hospital
Collaborator:
Hôpital de Hautepierre
Treatments:
Ropivacaine
Criteria
Inclusion Criteria:

- ASA Score I-III

- Scheduled for laparoscopic cholecystectomy

- Free from pain in preoperative period

- Not using analgesic drugs before surgery

- Without cognitive impairment or mental retardation

- Written informed consent

Exclusion Criteria:

- Emergency/urgency surgery

- Postoperative admission in an intensive care unit

- Cognitive impairment or mental retardation

- Progressive degenerative diseases of the CNS

- Seizures or chronic therapy with antiepileptic drugs

- Severe hepatic or renal impairment

- Pregnancy or lactation

- Allergy to one of the specific drugs under study

- Acute infection or inflammatory chronic disease

- Alcohol or drug addiction