Anesthesia ComplicationsNCT02488291
Effect of Sufentanil and Ropivacaine
A study testing 0.25 sufentanil, 0.5µg/ml sufentanil and 0.1% ropivacaine in people with Anesthesia Complications, run by Fudan University.
Trial summary
The investigators study the efficacy of epidural sufentanil/ropivacaine for analgesia labor in primiparas so as to decrease perinatal complications of analgesia labor. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Anesthesia Complications
- What is being tested?
- 0.25 sufentanil, 0.5µg/ml sufentanil and 0.1% ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Jun 2015
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients had regular prenatal examinations at the outpatient clinic;
- They were between 25 to 35 years of age)
- They had a gestational age ≥37 weeks and < 42 weeks;
- They had an estimated fetal weight ≥ 2,500 g and < 4,200 g.
Who cannot join
- a history of spinal surgery,
- platelet count <100×109 /L ,
- coagulation disorder,
- sensorimotor disorder of lower extremity,
- leg pain,
- puncture point infection,
Show all 10Show fewer
- heart disease history,
- pulmonary disease,
- liver and renal function disorder and
- a history of neuropsychiatry drugs.
About this study
Official title: Effect of 0.5µg/ml Sufentanil and Ropivacaine Towards Pregnant Women and Fetus in Analgesia Labor
The investigators study the efficacy of epidural sufentanil/ropivacaine for analgesia labor in primiparas so as to decrease perinatal complications of analgesia labor.
Read the detailed description
A prospective study of 120 full-term parturients receiving labor analgesia were randomly assigned into 2 groups: the 0.5Sufen group (N=60), the 0.25Sufen group (N=60).
- Conditions
- Anesthesia Complications
- Being tested
- 0.25 sufentanil, 0.5µg/ml sufentanil, 0.1% ropivacaine
- Keywords
- Epidural, Analgesia labor, Perinatal, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25 sufentanilDrug
Also called opiods
with different dosage
0.5µg/ml sufentanilDrug
Also called opiods
0.5µg/ml sufentanil
0.1% ropivacaineDrug
Also called Local Anesthetics
0.1% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| 0.5 sufentanil | Experimental | 0.5µg/ml sufentanil, 0.1% ropivacaine for 6ml/h Receives: Drug: 0.5µg/ml sufentanil; Drug: 0.1% ropivacaine |
| 0.25 sufentanil | Experimental | 0.25µg/ml sufentanil, 0.1% ropivacaine for 6ml/h Receives: Drug: 0.25 sufentanil; Drug: 0.1% ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS(visual analog pain score)
comparison with two groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia ComplicationsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Zeyong Yang, Fudan University
- Investigators
- Zeyong Yang, M.D., Principal investigator, Fudan University, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488291
- Sponsor's protocol ID
- IPMCH
- Status last verified
- Aug 2020
- First submitted
- 20 Jun 2015
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 0.5µg/ml Sufentanil and Ropivacaine Towards Pregnant Women and Fetus in Analgesia Labor
- ClinicalTrials.gov ID
- NCT02488291
- Acronym / sponsor ID
- IPMCH
- Conditions
- Anesthesia Complications
- Keywords
- Epidural, Analgesia labor, Perinatal, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- Apr 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 2 Jul 2015 (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 study the efficacy of epidural sufentanil/ropivacaine for analgesia labor in primiparas so as to decrease perinatal complications of analgesia labor.
Detailed description
A prospective study of 120 full-term parturients receiving labor analgesia were randomly assigned into 2 groups: the 0.5Sufen group (N=60), the 0.25Sufen group (N=60).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5 sufentanil | Experimental | Drug: 0.5µg/ml sufentanil, Drug: 0.1% ropivacaine0.5µg/ml sufentanil, 0.1% ropivacaine for 6ml/h |
| 0.25 sufentanil | Experimental | Drug: 0.25 sufentanil, Drug: 0.1% ropivacaine0.25µg/ml sufentanil, 0.1% ropivacaine for 6ml/h |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients had regular prenatal examinations at the outpatient clinic;
- They were between 25 to 35 years of age)
- They had a gestational age ≥37 weeks and < 42 weeks;
- They had an estimated fetal weight ≥ 2,500 g and < 4,200 g.
Key exclusion criteria (10 listed)
- a history of spinal surgery,
- platelet count <100×109 /L ,
- coagulation disorder,
- sensorimotor disorder of lower extremity,
- leg 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 |
|---|---|---|
| 0.25 sufentanilAlso: opiodswith different dosage | Drug | 0.25 sufentanil |
| 0.5µg/ml sufentanilAlso: opiods0.5µg/ml sufentanil | Drug | 0.5 sufentanil |
| 0.1% ropivacaineAlso: Local Anesthetics0.1% ropivacaine | Drug | 0.25 sufentanil, 0.5 sufentanil |
Primary outcome
VAS(visual analog pain score)
Time frame: 1 year
comparison with two groups
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 12 Aug 2020.
Related trials for Anesthesia Complications
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
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.
Zeyong Yang, M.D. principal investigator
Fudan University, Shanghai Jiaotong University
Questions about this trial
What is this clinical trial studying?
A study testing 0.25 sufentanil, 0.5µg/ml sufentanil and 0.1% ropivacaine in people with Anesthesia Complications, run by Fudan University.
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 10 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 12 Aug 2020. 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?
VAS(visual analog pain score) (time frame: 1 year). 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 12 Aug 2020.