Laparoscopic Surgical ProceduresPhase 3NCT00433316
Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy
A Phase 3 study testing ropivacaine and Aeroneb Pro Nezulizer, Aerogen, Ireland in people with Laparoscopic Surgical Procedures, run by Carmel Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Laparoscopic Surgical Procedures
- What is being tested?
- ropivacaine and Aeroneb Pro Nezulizer, Aerogen, Ireland
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2007to Oct 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
the Carmel Medical Center Ambulatory Gynecoendoscopic Unit
Haifa, 34362
About this study
Official title: 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.
- Conditions
- Laparoscopic Surgical Procedures
- Being tested
- ropivacaine, Aeroneb Pro Nezulizer, Aerogen, Ireland
- Keywords
- ropivacaine, laparoscopy, intraperitoneal, nebulization, pain, local analgesic, gynecology
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
Also called Narop
1% ropivacaine
Aeroneb Pro Nezulizer, Aerogen, IrelandDevice
Aeroneb Pro Nezulizer, Aerogen, Ireland
| Study group | Role | What they receive |
|---|---|---|
| study | Experimental | Receiving 10ml of 1% ropivacaine Receives: Drug: ropivacaine |
| Control | Placebo comparator | Receiving 10ml of saline Receives: Device: Aeroneb Pro Nezulizer, Aerogen, Ireland |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
Measured: early post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Yuval Kaufman, MD, Principal investigator, Carmel Medical Center, Haifa, IsraelReuven Pizov, Prof., Study director, Carmel Medical Center, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433316
- Sponsor's protocol ID
- CMC064113CTIL
- Other IDs
- HT 3758
- Status last verified
- Feb 2007
- First submitted
- 8 Feb 2007
- Last updated
- 20 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief by Continuous Intra-Peritoneal Nebulization of Ropivacaine During Gynecological Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT00433316
- Acronym / sponsor ID
- CMC064113CTIL
- Conditions
- Laparoscopic Surgical Procedures
- Keywords
- ropivacaine, laparoscopy, intraperitoneal, nebulization, pain, local analgesic, gynecology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 9 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study | Experimental | Drug: ropivacaineReceiving 10ml of 1% ropivacaine |
| Control | Placebo comparator | Device: Aeroneb Pro Nezulizer, Aerogen, IrelandReceiving 10ml of saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ropivacaineAlso: Narop1% ropivacaine | Drug | study |
| Aeroneb Pro Nezulizer, Aerogen, IrelandAeroneb Pro Nezulizer, Aerogen, Ireland | Device | Control |
Primary outcome
VAS score
Time frame: early post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuval Kaufman, MD principal investigator
Carmel Medical Center, Haifa, Israel
Reuven Pizov, Prof. study director
Carmel Medical Center, Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ropivacaine and Aeroneb Pro Nezulizer, Aerogen, Ireland in people with Laparoscopic Surgical Procedures, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: early post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2008; AzTrials last refreshed its copy on 8 Nov 2026.