Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery

Study Overview
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Brief Summary
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The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg may prevent the use of morphine during the first day after laparoscopic ovarian cyst surgery.

Detailed Description
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In a recent study the investigators found that nebulization of Ropivacaine 30 mg before or after gynaecologic laparoscopic surgery significantly reduces postoperative pain and postoperative morphine consumption. Ropivacaine was effectively administered with non-heating nebulizers (AeronebPro®). However, almost all patients still use morphine after surgery. The investigators hypothesize that intraperitoneal nebulization of Ropivacaine 150 mg may prevent the use of morphine after the laparoscopic ovarian cyst surgery.

Official Title
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Do Peritoneal Nebulization of Ropivacaine Reduce the Use of Morphine After Short Gynecologic Laparoscopic Surgery?

Conditions
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Ovarian Cysts

Intervention / Treatment
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* Drug: Ropivacaine nebulization
* Drug: Ropivacaine instillation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females 18-65 years old ASA Score I-III Scheduled for ovarian cyst laparoscopic surgery 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine nebulization<br>Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity | Drug: Ropivacaine nebulization<br>* Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity.<br>* Other names: Nebulization;|
| Active Comparator: Ropivacaine instillation<br>Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity before surgery | Drug: Ropivacaine instillation<br>* Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity.<br>* Other names: Instillation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption (mg) | The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display. | Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | Postoperative pain will be assessed by numeric ranking scale (NRS 0 to 10 points) at rest (static NRS) and after deep inspiration or cough (dynamic NRS). Pain after surgery will be differentiated as abdominal, wall pain, port wound pain, back pain and shoulder pain. The proportion of patients with adequate pain control after surgery (dynamic NRS < 3) will also be assessed. | Up to 24 hours | 
| Time of unassisted walking | 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. | Up to 24 hours | 
| 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 and surgical database. | Up to 24 hours | 
| Hospital stay | We define hospital stay as the time in hours elapsed between surgery and hospital discharge. We evaluate the hospital stay with the post-anesthetic discharge scoring system (Modified-PADSS). | Up to 24 hours | 
| Quality of life after surgery | Quality of life will be assessed using the SF-36 questionnaire | Four weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Cysts, Nebulization, Ropivacaine