Post Operative Pain ManagementNCT01917045
Different Lipid Soluble Opioids for Gynecologic Laparoscopic Surgery Postoperative Patient-controlled Analgesia
A study testing Sufentanil (R30730, brand name Sufenta), Sufentanil (R30730, brand name Sufenta) + Morphine and Morphine in people with Post Operative Pain Management, run by Peking University First Hospital.
Trial summary
The investigators noticed that Body Fat Ratio might have great influence on the efficacy of different lipid soluble anesthetics. The objective of this clinical trial was to compare the effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Post Operative Pain Management
- What is being tested?
- Sufentanil (R30730, brand name Sufenta), Sufentanil (R30730, brand name Sufenta) + Morphine and Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Mar 2013
- Phase
- Interventional
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists grade I-II
- adults aged over 20 and below 50 years old,
- non-smoker,
- with normal hepatic and renal function.
Who cannot join
- smoker ,
- any kind of mental disorder or
- history use of analgesics for more than 10 consecutive days,
- asthma; and
- those with digestion tract disorder who would get nausea or vomiting much more easily than normal people.
About this study
Official title: Different Lipid Soluble Opioids for Gynecologic Laparoscopic Surgery Postoperative Patient-controlled Analgesia --- a Double Blind Randomized Study
The investigators noticed that Body Fat Ratio might have great influence on the efficacy of different lipid soluble anesthetics. The objective of this clinical trial was to compare the effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics.
Read the detailed description
The objective of this clinical trial was to compare the effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics.
- Conditions
- Post Operative Pain Management
- Being tested
- Sufentanil (R30730, brand name Sufenta), Sufentanil (R30730, brand name Sufenta) + Morphine, Morphine
- Keywords
- sufentanil, morphine, postoperative pain control, body fat percentage, gynecology laparoscopic surgery, lipid solubility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil (R30730, brand name Sufenta)Drug
sufentanil 1ug/ml
Sufentanil (R30730, brand name Sufenta) + MorphineDrug
sufentanil 0.5ug/ml+morphine 0.25mg/ml
MorphineDrug
morphine 0. 5mg/ml
| Study group | Role | What they receive |
|---|---|---|
| low body fat percentage | Experimental | body fat percentage less than 30% Receives: Drug: Sufentanil (R30730, brand name Sufenta); Drug: Sufentanil (R30730, brand name Sufenta) + Morphine; Drug: Morphine |
| heigh body fat percentage | Experimental | body fat percentage more than 30% Receives: Drug: Sufentanil (R30730, brand name Sufenta); Drug: Sufentanil (R30730, brand name Sufenta) + Morphine; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue pain scores
we evaluate visual analogue pain scores at different time points within 24 hours after surgery
Measured: 24hour
Secondary outcomes (1)
nausea & vomiting
we evaluate nausea \& vomiting at different time points within 24 hours after surgery. we ask the patient if she feel nausea or/and occured vomit, if so, 1 time will be recorded in the time point for incidence.
Measured: 24hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain ManagementStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhouYan, Peking University First Hospital
- Investigators
- zhou yan, MD, Principal investigator, PKU 1st hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917045
- Sponsor's protocol ID
- LSOPCA-021
- Status last verified
- Aug 2013
- First submitted
- 14 Jun 2013
- Last updated
- 6 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Lipid Soluble Opioids for Gynecologic Laparoscopic Surgery Postoperative Patient-controlled Analgesia --- a Double Blind Randomized Study
- ClinicalTrials.gov ID
- NCT01917045
- Acronym / sponsor ID
- LSOPCA-021
- Conditions
- Post Operative Pain Management
- Keywords
- sufentanil, morphine, postoperative pain control, body fat percentage, gynecology laparoscopic surgery, lipid solubility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 6 Aug 2013 (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.
The investigators noticed that Body Fat Ratio might have great influence on the efficacy of different lipid soluble anesthetics. The objective of this clinical trial was to compare the effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics.
Detailed description
The objective of this clinical trial was to compare the effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low body fat percentage | Experimental | Drug: Sufentanil (R30730, brand name Sufenta), Drug: Sufentanil (R30730, brand name Sufenta) + Morphine, Drug: Morphinebody fat percentage less than 30% |
| heigh body fat percentage | Experimental | Drug: Sufentanil (R30730, brand name Sufenta), Drug: Sufentanil (R30730, brand name Sufenta) + Morphine, Drug: Morphinebody fat percentage more than 30% |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists grade I-II
- adults aged over 20 and below 50 years old,
- non-smoker,
- with normal hepatic and renal function.
Key exclusion criteria (5 listed)
- smoker ,
- any kind of mental disorder or
- history use of analgesics for more than 10 consecutive days,
- asthma; and
- those with digestion tract disorder who would get nausea or vomiting much more easily than normal people.
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 |
|---|---|---|
| Sufentanil (R30730, brand name Sufenta)sufentanil 1ug/ml | Drug | heigh body fat percentage, low body fat percentage |
| Sufentanil (R30730, brand name Sufenta) + Morphinesufentanil 0.5ug/ml+morphine 0.25mg/ml | Drug | heigh body fat percentage, low body fat percentage |
| Morphinemorphine 0. 5mg/ml | Drug | heigh body fat percentage, low body fat percentage |
Primary outcome
visual analogue pain scores
Time frame: 24hour
we evaluate visual analogue pain scores at different time points within 24 hours after surgery
1 secondary outcome
nausea & vomiting
Time frame: 24hour
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 6 Aug 2013.
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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.
zhou yan, MD principal investigator
PKU 1st hospital
Questions about this trial
What is this clinical trial studying?
A study testing Sufentanil (R30730, brand name Sufenta), Sufentanil (R30730, brand name Sufenta) + Morphine and Morphine in people with Post Operative Pain Management, run by Peking University First Hospital.
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 5 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 6 Aug 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 analogue pain scores (time frame: 24hour). 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 6 Aug 2013.