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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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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 of the instillation technique may be related to inadequate distribution of local anesthetic throughout the peritoneal surface. In contrast, nebulization should provide a uniform spread of drugs throughout the peritoneal cavity and thus may be beneficial to improve pain relief after laparoscopic procedures. The investigators reported that a microvibration-based nebulization device (Aeroneb Pro® system, Aerogen, Galway, Ireland) could be used for ropivacaine delivery into the insufflation gas required to create pneumorpeitoneum. The investigators hypothesized that intraperitoneal ropivacaine nebulization would provide superior pain relief than ropivacaine instillation after gynecologic laparoscopic surgery. This randomized, double blind, controlled clinical trial was designed to assess the analgesic efficacy of ropivacaine nebulization before or after surgery compared with intraperitoneal ropivacaine instillation and placebo after gynecologic laparoscopic procedures.

Conditions

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Gynecologic Laparoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CONTROL group

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

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

PREOPERATIVE nebulization

Group Type EXPERIMENTAL

Ropivacaine 30 mg

Intervention Type DRUG

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

POSTOPERATIVE nebulization

Group Type EXPERIMENTAL

Ropivacaine 30 mg

Intervention Type DRUG

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

INSTILLATION group

Group Type ACTIVE_COMPARATOR

Ropivacaine 100 mg

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Ropivacaine 100 mg

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

Intervention Type DRUG

saline

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No