AnalgesiaPhase 4NCT00772187
Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.
A Phase 4 study testing morphine, intrathecal analgesia (morphine) and general anesthesia (fentanyl) in people with Analgesia, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Main Hypothesis: laparoscopic surgery is very painful to patient during and after surgery. We would like to compare different analgesic methods. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia
- What is being tested?
- morphine, intrathecal analgesia (morphine) and general anesthesia (fentanyl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2007to Sep 2009
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laparoscopic (general) Surgery
- Age>18
- ASA<4
- Morning surgery
Who cannot join
- Patient refusal
- contra-indication for treatment
Trial locations and contacts
1 site in 1 country.
About this study
Main Hypothesis: laparoscopic surgery is very painful to patient during and after surgery. We would like to compare different analgesic methods.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morphineDrug
Single dose: 0.1-0.5 mg
intrathecal analgesia (morphine)Drug
0.1-0.5 mg of morphine
general anesthesia (fentanyl)Drug
general anesthesia alone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | General anesthesia + I.V pca Receives: Drug: general anesthesia (fentanyl) |
| 2 | Experimental | General anesthesia + spinal analgesia + I.V pca Receives: Drug: morphine; Drug: intrathecal analgesia (morphine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Good analgesic method with minimal side effect.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startOct 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772187
- Sponsor's protocol ID
- Rambam2690CTIL
- Status last verified
- Jul 2010
- First submitted
- 21 May 2008
- Last updated
- 22 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.
- ClinicalTrials.gov ID
- NCT00772187
- Acronym / sponsor ID
- Rambam2690CTIL
- Conditions
- Analgesia
- Keywords
- Laparoscopic surgery (general surgery).
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 15 Oct 2008 (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.
Main Hypothesis: laparoscopic surgery is very painful to patient during and after surgery. We would like to compare different analgesic methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: general anesthesia (fentanyl)General anesthesia + I.V pca |
| 2 | Experimental | Drug: morphine, Drug: intrathecal analgesia (morphine)General anesthesia + spinal analgesia + I.V pca |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Laparoscopic (general) Surgery
- Age>18
- ASA<4
- Morning surgery
Key exclusion criteria (2 listed)
- Patient refusal
- contra-indication for treatment
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 |
|---|---|---|
| morphineSingle dose: 0.1-0.5 mg | Drug | 2 |
| intrathecal analgesia (morphine)0.1-0.5 mg of morphine | Drug | 2 |
| general anesthesia (fentanyl)general anesthesia alone | Drug | 1 |
Primary outcome
Good analgesic method with minimal side effect.
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 22 Sep 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing morphine, intrathecal analgesia (morphine) and general anesthesia (fentanyl) in people with Analgesia, run by Rambam Health Care Campus 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 4 inclusion and 2 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 22 Sep 2010. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Good analgesic method with minimal side effect.. 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 22 Sep 2010.