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

Phase 3

Completed

• Conditions: Gynecologic Laparoscopic Surgery
• Interventions: Drug: Ropivacaine 100 mg; Drug: saline; Drug: Ropivacaine 30 mg

• Registration Number: NCT01512914
• Lead Sponsor: San Gerardo Hospital

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 assess the effects of a novel intraperitoneal local anesthetic administration technique using nebulization on pain relief after gynecologic laparoscopic surgery.

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 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.

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2012-01
• Study First Submitted: 2012-01-15
• Study First Submitted QC: 2012-01-18
• Last Update Submitted: 2012-01-18
• Study First Posted: 2012-01-19
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INSTILLATION group	Ropivacaine 100 mg	-
CONTROL group	saline	-
PREOPERATIVE nebulization	Ropivacaine 30 mg	-
POSTOPERATIVE nebulization	Ropivacaine 30 mg	-

Primary Outcome Measures

Name	Time	Method
postoperative pain	24 hours	Postoperative pain was assessed by NRS (0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS). The proportion of patients with adequate pain control after surgery (dynamic NRS \< 3) will also be assessed.

Secondary Outcome Measures

Name	Time	Method
morphine consumption	24 hours	The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display
Unassisted walking time	24 hours	Unassisted walking time is defined as the time in hours between PACU discharge and when the patient is able to walk out of his room and back to bed without any assistance.
Hospital stay	between surgery and discharge	We define hospital stay as the elapsed time between surgery and hospital discharge
hospital morbidity	up to discharge	All complications or adverse effects associated or possibly associated with the interventions under study, surgery or anesthesia will be quantified using the anesthesia charts, surgical charts, surgical database.

Trial Locations

Locations (1)

San Gerardo Hospital; 🇮🇹 Monza, MB, Italy