Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section
Comparison of the Impact Between Minimally Invasive and Traditional Spinal Anesthesia for Cesarean Section in Maternal Anticoagulation Therapy:Randomized Controlled Trial
1 other identifier
interventional
200
1 country
1
Brief 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 hematoma.Therefore, we propose minimally invasive spinal anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 16, 2016
CompletedFirst Posted
Study publicly available on registry
December 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedJuly 5, 2017
July 1, 2017
8 months
November 16, 2016
July 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual analogue score of post-dural puncture headache
1 to 7 days after operation
Secondary Outcomes (1)
Visual analogue score of low back pain
1 to 7 days after operation
Study Arms (2)
traditional group
EXPERIMENTALTraditional group patients will receive cutting type 22 gauge needles
minimally invasive group
EXPERIMENTALminimally invasive group patients will receive pen type 27 gauge needles
Interventions
minimally invasive group patients will receive pen type 27 gauge needles.
traditional group patients will receive cutting type 22 gauge needles.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200127, China
Related Publications (1)
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.
PMID: 30636632DERIVED
Study Officials
- STUDY CHAIR
WEIFENG YU, MD
Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
November 16, 2016
First Posted
December 8, 2016
Study Start
November 1, 2016
Primary Completion
July 1, 2017
Study Completion
November 1, 2017
Last Updated
July 5, 2017
Record last verified: 2017-07