- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00433316
Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy
June 19, 2008 updated by: Carmel Medical Center
Pain Relief by Continuous Intra-Peritoneal Nebulization of Ropivacaine During Gynecological Laparoscopic Surgery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Haifa, Israel, 34362
- the Carmel Medical Center Ambulatory Gynecoendoscopic Unit
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study
Receiving 10ml of 1% ropivacaine
|
1% ropivacaine
Other Names:
|
Placebo Comparator: Control
Receiving 10ml of saline
|
Aeroneb Pro Nezulizer, Aerogen, Ireland
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
VAS score
Time Frame: early post-operative
|
early post-operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yuval Kaufman, MD, Carmel Medical Center, Haifa, Israel
- Study Director: Reuven Pizov, Prof., Carmel Medical Center, Haifa, Israel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
February 8, 2007
First Submitted That Met QC Criteria
February 8, 2007
First Posted (Estimate)
February 9, 2007
Study Record Updates
Last Update Posted (Estimate)
June 20, 2008
Last Update Submitted That Met QC Criteria
June 19, 2008
Last Verified
February 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMC064113CTIL
- HT 3758
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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