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

NCT01512914 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-01-19

No results posted yet for this study

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.

Conditions

  • Gynecologic Laparoscopic Surgery

Interventions

DRUG

Ropivacaine 30 mg

preoperative instillation of saline 20 ml, nebulization of ropivacaine 1% 3 ml (30 mg) before surgery and nebulization of saline 3 ml after surgery

DRUG

Ropivacaine 30 mg

preoperative instillation of saline 20 ml, preoperative nebulization of saline 3 ml and nebulization of ropivacaine 1% 3 ml (30 mg) after surgery

DRUG

Ropivacaine 100 mg

preoperative instillation of ropivacaine 0,5% 20 ml (100 mg) and nebulization of saline 3 ml before and after surgery

DRUG

saline

preoperative instillation of saline 20 ml and nebulization of saline before and after surgery

Sponsors & Collaborators

  • San Gerardo Hospital

    lead OTHER

Principal Investigators

  • Pablo M Ingelmo, MD · San Gerardo Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01512914 on ClinicalTrials.gov