AnticoagulationNCT02987192
Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section
A study testing pen type 27 gauge needles and cutting type 22 gauge needles in people with Anticoagulation and Minimally Invasive, run by RenJi Hospital at 1 site in China.
Trial summary
Spinal canal anesthesia is marked the most commonly used method of cesarean section. Traditional spinal anesthesia may cause post-dural puncture headache and low back pain.Plenty of parturients are undergoing anticoagulation therapy.They may be forced to accept general anesthesia in order to avoid epidural… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Anticoagulation, Minimally Invasive, Spinal Anesthesia
- What is being tested?
- pen type 27 gauge needles and cutting type 22 gauge needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Nov 2017
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- puerpera accept anticoagulation therapy
- American society of anesthesiologists(ASA) classification I to II level
- Willing to participate in this study and signed an informed consent
- pregnancy at least 37 weeks
Who cannot join
- platelet count less than 50*100000000
- International Normalized Ratio more than 1.5
- site of puncture with infection
- with intracranial hypertension
- with lumbar spine or spinal cord disorders
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200127
DAN HUANG, MS, 15921108822, huangdan363@163.com
JIE ZHOU, MS, 13601693227, zhoujie1486@renji.com
About this study
Official title: Comparison of the Impact Between Minimally Invasive and Traditional Spinal Anesthesia for Cesarean Section in Maternal Anticoagulation Therapy:Randomized Controlled Trial
Spinal canal anesthesia is marked the most commonly used method of cesarean section. Traditional spinal anesthesia may cause post-dural puncture headache and low back pain.Plenty of parturients are undergoing anticoagulation therapy.They may be forced to accept general anesthesia in order to avoid epidural hematoma.Therefore, we propose minimally invasive spinal anesthesia.
Read the detailed description
Traditional group patients will receive cutting type 22 gauge needles, while minimally invasive group patients will receive pen type 27 gauge needles.Patients will be blinded to the intervention allocations. Spinal anesthesia will be performed with a standardized technique. Lumbar puncture will be performed through an interspace (L3-4 or L2-3) with patients in a lateral decubitus position. After free flow of cerebrospinal fluid through the needle tip be verified, 2ml ropivacaine will be injected. We will record puncture situation, anesthesia plane and measure post-dural puncture headache, post-operative back pain and epidural hematoma.
- Conditions
- Anticoagulation, Minimally Invasive, Spinal Anesthesia
- Being tested
- pen type 27 gauge needles, cutting type 22 gauge needles
- Keywords
- spinal anesthesia, anticoagulation, minimally invasive, Cesarean Section, Maternal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pen type 27 gauge needlesDevice
minimally invasive group patients will receive pen type 27 gauge needles.
cutting type 22 gauge needlesDevice
traditional group patients will receive cutting type 22 gauge needles.
| Study group | Role | What they receive |
|---|---|---|
| traditional group | Experimental | Traditional group patients will receive cutting type 22 gauge needles Receives: Device: cutting type 22 gauge needles |
| minimally invasive group | Experimental | minimally invasive group patients will receive pen type 27 gauge needles Receives: Device: pen type 27 gauge needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score of post-dural puncture headache
Measured: 1 to 7 days after operation
Secondary outcomes (1)
Visual analogue score of low back pain
Measured: 1 to 7 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnticoagulationStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAN HUANG, RenJi Hospital
- Investigators
- WEIFENG YU, MD, Study chair, Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987192
- Sponsor's protocol ID
- MICS2016033
- Status last verified
- Jul 2017
- First submitted
- 16 Nov 2016
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Huang D, Zhu L, Chen J, Zhou J. Minimally invasive spinal anesthesia for cesarean section in maternal anticoagulation therapy: a randomized controlled trial. BMC Anesthesiol. 2019 Jan 12;19(1):11. doi: 10.1186/s12871-018-0679-1.
PubMed 30636632
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Impact Between Minimally Invasive and Traditional Spinal Anesthesia for Cesarean Section in Maternal Anticoagulation Therapy:Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02987192
- Acronym / sponsor ID
- MICS2016033
- Conditions
- Anticoagulation, Minimally Invasive, Spinal Anesthesia
- Keywords
- spinal anesthesia, anticoagulation, minimally invasive, Cesarean Section, Maternal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 8 Dec 2016 (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.
Spinal canal anesthesia is marked the most commonly used method of cesarean section. Traditional spinal anesthesia may cause post-dural puncture headache and low back pain.Plenty of parturients are undergoing anticoagulation therapy.They may be forced to accept general anesthesia in order to avoid epidural hematoma.Therefore, we propose minimally invasive spinal anesthesia.
Detailed description
Traditional group patients will receive cutting type 22 gauge needles, while minimally invasive group patients will receive pen type 27 gauge needles.Patients will be blinded to the intervention allocations. Spinal anesthesia will be performed with a standardized technique. Lumbar puncture will be performed through an interspace (L3-4 or L2-3) with patients in a lateral decubitus position. After free flow of cerebrospinal fluid through the needle tip be verified, 2ml ropivacaine will be injected. We will record puncture situation, anesthesia plane and measure post-dural puncture headache, post-operative back pain and epidural hematoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional group | Experimental | Device: cutting type 22 gauge needlesTraditional group patients will receive cutting type 22 gauge needles |
| minimally invasive group | Experimental | Device: pen type 27 gauge needlesminimally invasive group patients will receive pen type 27 gauge needles |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- puerpera accept anticoagulation therapy
- American society of anesthesiologists(ASA) classification I to II level
- Willing to participate in this study and signed an informed consent
- pregnancy at least 37 weeks
Key exclusion criteria (5 listed)
- platelet count less than 50*100000000
- International Normalized Ratio more than 1.5
- site of puncture with infection
- with intracranial hypertension
- with lumbar spine or spinal cord disorders
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 |
|---|---|---|
| pen type 27 gauge needlesminimally invasive group patients will receive pen type 27 gauge needles. | Device | minimally invasive group |
| cutting type 22 gauge needlestraditional group patients will receive cutting type 22 gauge needles. | Device | traditional group |
Primary outcome
Visual analogue score of post-dural puncture headache
Time frame: 1 to 7 days after operation
1 secondary outcome
Visual analogue score of low back pain
Time frame: 1 to 7 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Derived from this study: PubMed 30636632Huang D, Zhu L, Chen J, Zhou J. Minimally invasive spinal anesthesia for cesarean section in maternal anticoagulation therapy: a randomized controlled trial. BMC Anesthesiol. 2019 Jan 12;19(1):11. doi: 10.1186/s12871-018-0679-1.
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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.
WEIFENG YU, MD study chair
Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pen type 27 gauge needles and cutting type 22 gauge needles in people with Anticoagulation and Minimally Invasive, run by RenJi Hospital at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 5 Jul 2017. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DAN HUANG, MS (15921108822, huangdan363@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue score of post-dural puncture headache (time frame: 1 to 7 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02987192, which also lists 1 linked publication.
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 5 Jul 2017.