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Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy

NCT ID: NCT00433316

Last Updated: 2008-06-20

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

2007-02-28

Study Completion Date

2007-10-31

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 gynecological laparoscopic surgery.

Detailed Description

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Conditions

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Laparoscopic Surgical Procedures

Keywords

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ropivacaine laparoscopy intraperitoneal nebulization pain local analgesic gynecology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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study

Receiving 10ml of 1% ropivacaine

Group Type EXPERIMENTAL

ropivacaine

Intervention Type DRUG

1% ropivacaine

Control

Receiving 10ml of saline

Group Type PLACEBO_COMPARATOR

Aeroneb Pro Nezulizer, Aerogen, Ireland

Intervention Type DEVICE

Aeroneb Pro Nezulizer, Aerogen, Ireland

Interventions

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ropivacaine

1% ropivacaine

Intervention Type DRUG

Aeroneb Pro Nezulizer, Aerogen, Ireland

Aeroneb Pro Nezulizer, Aerogen, Ireland

Intervention Type DEVICE

Other Intervention Names

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Narop

Eligibility Criteria

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Inclusion Criteria

* Elective gynecologic laparoscopic surgery including unilateral or bilateral salpingo-oopherectomy or ovarian cystectomy.
* The patient is not participating in other medical study at present or in the last 30 days.
* The patient signed on an informed consent.
* Age 18 years and above.
* ASA (American Society of Anesthesiologists) physical status grade 1- 2.

Exclusion Criteria

* Allergy to Ropivacaine, other local anesthetics or other medications listed in the protocol.
* The patient is participating in other medical experiment at present or in the last 30 days.
* Acute Pelvic Inflammatory Disease.
* Coumadin or Aspirin treatment.
* ASA physical status grade 3-4.
* Age \< 18 years.
* Significant arrythmias
* Analgesic treatment for chronic pain
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Carmel Medical Center

Principal Investigators

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Yuval Kaufman, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center, Haifa, Israel

Reuven Pizov, Prof.

Role: STUDY_DIRECTOR

Carmel Medical Center, Haifa, Israel

Locations

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the Carmel Medical Center Ambulatory Gynecoendoscopic Unit

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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HT 3758

Identifier Type: -

Identifier Source: secondary_id

CMC064113CTIL

Identifier Type: -

Identifier Source: org_study_id