Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic 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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-12-31

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.

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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.

Conditions

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Ovarian Cysts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ropivacaine nebulization

Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity

Group Type EXPERIMENTAL

Ropivacaine nebulization

Intervention Type DRUG

Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity.

Ropivacaine instillation

Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity before surgery

Group Type ACTIVE_COMPARATOR

Ropivacaine instillation

Intervention Type DRUG

Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity.

Interventions

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Ropivacaine nebulization

Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity.

Intervention Type DRUG

Ropivacaine instillation

Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity.

Intervention Type DRUG

Other Intervention Names

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Ropivacaine Nebulization Ropivacaine Instillation

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No