Gynecological LaparoscopyPhase 3PSDRNCT00927979
Pain Relief by Intra-Peritoneal Nebulization of Ropivacaine Under Remifentanil Anesthesia for Gynecological Laparoscopy
A Phase 3 study testing 10 mLRopivacaine 1%, Water for injection and 10 mL Ropivacaine 1% in people with Gynecological Laparoscopy, run by Carmel Medical Center.
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 gynecologic laparoscopic surgery. This is a second steady with protocol of general anesthesia used of Remifentanil. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecological Laparoscopy
- What is being tested?
- 10 mLRopivacaine 1%, Water for injection and 10 mL Ropivacaine 1%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Oct 2010
- 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Phase 3 Prospective, Randomized, Controlled and Double-blinded Second Trial on Pain Relief by Continuous Intra-peritoneal Nebulization of Ropivacaine Under Remifentanil Anesthesia, 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 gynecologic laparoscopic surgery. This is a second steady with protocol of general anesthesia used of Remifentanil.
Read the detailed description
Outcome Measures :
- VAS score
- Use of analgesics during operation and postoperative period
- Conditions
- Gynecological Laparoscopy
- Being tested
- 10 mLRopivacaine 1%, Water for injection, 10 mL Ropivacaine 1%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mLRopivacaine 1%Drug
Intraperitoneal nebulization of 10 mL Ropivacaine 1%
Water for injectionDrug
Intraperitoneal nebulization of 10 mL water for injection
10 mL Ropivacaine 1%Drug
Intraperitoneal nebulization of 10 mL Ropivacaine 1%
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Experimental | Not described Receives: Drug: 10 mLRopivacaine 1%; Drug: 10 mL Ropivacaine 1% |
| Water for injection | Placebo comparator | Not described Receives: Drug: Water for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score (VAS)
Measured: 24 hours
Secondary outcomes (1)
Use of Analgesics
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological LaparoscopyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927979
- Sponsor's protocol ID
- CMC090074CTIL
- Other IDs
- PSDR
- Acronym
- PSDR
- Status last verified
- Jun 2011
- First submitted
- 24 Jun 2009
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Prospective, Randomized, Controlled and Double-blinded Second Trial on Pain Relief by Continuous Intra-peritoneal Nebulization of Ropivacaine Under Remifentanil Anesthesia, During Gynecological Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT00927979
- Acronym / sponsor ID
- PSDR / CMC090074CTIL
- Conditions
- Gynecological Laparoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 25 Jun 2009 (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 gynecologic laparoscopic surgery. This is a second steady with protocol of general anesthesia used of Remifentanil.
Detailed description
Outcome Measures :
- VAS score
- Use of analgesics during operation and postoperative period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Experimental | Drug: 10 mLRopivacaine 1%, Drug: 10 mL Ropivacaine 1% |
| Water for injection | Placebo comparator | Drug: Water for injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| 10 mLRopivacaine 1%Intraperitoneal nebulization of 10 mL Ropivacaine 1% | Drug | Ropivacaine |
| Water for injectionIntraperitoneal nebulization of 10 mL water for injection | Drug | Water for injection |
| 10 mL Ropivacaine 1%Intraperitoneal nebulization of 10 mL Ropivacaine 1% | Drug | Ropivacaine |
Primary outcome
Visual Analog Score (VAS)
Time frame: 24 hours
1 secondary outcome
Use of Analgesics
Time frame: 24 hours
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 28 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10 mLRopivacaine 1%, Water for injection and 10 mL Ropivacaine 1% in people with Gynecological Laparoscopy, run by Carmel Medical Center.
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 6 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 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Visual Analog Score (VAS) (time frame: 24 hours). 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 28 Jun 2011.