Pain Relief by Intra-Peritoneal Nebulization of Ropivacaine Under Remifentanil Anesthesia for Gynecological Laparoscopy

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-10-31

Brief Summary

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In our prospective, randomized, placebo controlled and double-blinded study we will study the efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecologic laparoscopic surgery. This is a second steady with protocol of general anesthesia used of Remifentanil.

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Detailed Description

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Outcome Measures :

* VAS score
* Use of analgesics during operation and postoperative period

Conditions

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Gynecological Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ropivacaine

Group Type EXPERIMENTAL

10 mLRopivacaine 1%

Intervention Type DRUG

Intraperitoneal nebulization of 10 mL Ropivacaine 1%

10 mL Ropivacaine 1%

Intervention Type DRUG

Intraperitoneal nebulization of 10 mL Ropivacaine 1%

Water for injection

Group Type PLACEBO_COMPARATOR

Water for injection

Intervention Type DRUG

Intraperitoneal nebulization of 10 mL water for injection

Interventions

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10 mLRopivacaine 1%

Intraperitoneal nebulization of 10 mL Ropivacaine 1%

Intervention Type DRUG

Water for injection

Intraperitoneal nebulization of 10 mL water for injection

Intervention Type DRUG

10 mL Ropivacaine 1%

Intraperitoneal nebulization of 10 mL Ropivacaine 1%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elective gynecological laparoscopic surgery including unilateral or bilateral salpingo-oophorectomy or ovarian cystectomy
* Patient not participating in other medical study at present or during the last 30 days
* Patient is capable of reading, understanding and signing on an informed consent
* Age 18 years and above
* ASA physical status grade 1-2

Exclusion Criteria

* Allergy to ropivacaine or other local anesthetics or other medications listed in the protocol
* Acute pelvic inflammatory disease
* Coumadin or aspirin treatment
* Significant arrythmias
* Analgesic treatment for chronic pain
* BMI\>35

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes