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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00433316 |
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Date of registration:
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08/02/2007 |
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Primary sponsor: |
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Public title:
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Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy
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Scientific title:
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Pain Relief by Continuous Intra-Peritoneal Nebulization of Ropivacaine During Gynecological Laparoscopic Surgery |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00433316 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Israel
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Contacts
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Name:
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Reuven Pizov, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Carmel Medical Center, Haifa, Israel |
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Name:
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Yuval Kaufman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Carmel Medical Center, Haifa, Israel |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Laparoscopic Surgical Procedures
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Intervention(s)
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Device: Aeroneb Pro Nezulizer, Aerogen, Ireland
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Drug: ropivacaine
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Primary Outcome(s)
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VAS score
[Time Frame: early post-operative]
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Secondary ID(s)
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CMC064113CTIL
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HT 3758
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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