Minimally Invasive Lumbar Aneasthesia Used for Cesarean S... | NCT02987192

Studies
Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section

NCT02987192

Sponsor

RenJi Hospital

Status

Unknown status

Last Update Posted

Jul 5, 2017Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Anticoagulation
Minimally Invasive
Spinal Anesthesia

Interventions

pen type 27 gauge needles
cutting type 22 gauge needles

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Jul 2017Estimated

Completion Date

Nov 2017Estimated

First Submitted Date

Nov 16, 2016

First Submission Date that Met QC Criteria

Dec 7, 2016

First Posted Date

Dec 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2017

Last Update Posted Date

Jul 5, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
traditional group	Experimental	Traditional group patients will receive cutting type 22 gauge needles	Device: cutting type 22 gauge needles
minimally invasive group	Experimental	minimally invasive group patients will receive pen type 27 gauge needles	Device: pen type 27 gauge needles

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pen type 27 gauge needles	Device	minimally invasive group patients will receive pen type 27 gauge needles.	minimally invasive group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual analogue score of post-dural puncture headache		1 to 7 days after operation

Secondary Outcomes

Measure	Description	Time Frame
Visual analogue score of low back pain		1 to 7 days after operation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
DAN HUANG, MS	Contact	15921108822		huangdan363@163.com
JIE ZHOU, MS	Contact	13601693227		zhoujie1486@renji.com

Overall Officials

Name	Affiliation	Role
WEIFENG YU, MD	Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renji Hospital, Shanghai Jiao Tong University, School of Medicine	Recruiting	Shanghai	Shanghai Municipality	200127	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30636632	Derived	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.

Type	Date	Date Unknown
Release	Jan 7, 2019
Reset	Apr 9, 2019