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

Study Overview
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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.

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.

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

Conditions
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Gynecologic Laparoscopic Surgery

Intervention / Treatment
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* Drug: Ropivacaine 30 mg
* Drug: Ropivacaine 30 mg
* Drug: Ropivacaine 100 mg
* Drug: saline


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: CONTROL group<br> | Drug: saline<br>* preoperative instillation of saline 20 ml and nebulization of saline before and after surgery<br>|
| Experimental: PREOPERATIVE nebulization<br> | Drug: Ropivacaine 30 mg<br>* preoperative instillation of saline 20 ml, nebulization of ropivacaine 1% 3 ml (30 mg) before surgery and nebulization of saline 3 ml after surgery<br>|
| Experimental: POSTOPERATIVE nebulization<br> | Drug: Ropivacaine 30 mg<br>* preoperative instillation of saline 20 ml, preoperative nebulization of saline 3 ml and nebulization of ropivacaine 1% 3 ml (30 mg) after surgery<br>|
| Active Comparator: INSTILLATION group<br> | Drug: Ropivacaine 100 mg<br>* preoperative instillation of ropivacaine 0,5% 20 ml (100 mg) and nebulization of saline 3 ml before and after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption | The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display | 24 hours | 
| Unassisted walking time | 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. | 24 hours | 
| Hospital stay | We define hospital stay as the elapsed time between surgery and hospital discharge | between surgery and discharge | 
| hospital morbidity | 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. | up to discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gynecologic laparoscopic surgery, Postoperative pain, Nebulization, Ropivacaine