Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section

NCT ID: NCT02987192

Last Updated: 2017-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-11-30

Brief Summary

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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

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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

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Anticoagulation Minimally Invasive Spinal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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traditional group

Traditional group patients will receive cutting type 22 gauge needles

Group Type EXPERIMENTAL

cutting type 22 gauge needles

Intervention Type DEVICE

traditional group patients will receive cutting type 22 gauge needles.

minimally invasive group

minimally invasive group patients will receive pen type 27 gauge needles

Group Type EXPERIMENTAL

pen type 27 gauge needles

Intervention Type DEVICE

minimally invasive group patients will receive pen type 27 gauge needles.

Interventions

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pen type 27 gauge needles

minimally invasive group patients will receive pen type 27 gauge needles.

Intervention Type DEVICE

cutting type 22 gauge needles

traditional group patients will receive cutting type 22 gauge needles.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. puerpera accept anticoagulation therapy
2. American society of anesthesiologists(ASA) classification I to II level
3. Willing to participate in this study and signed an informed consent
4. pregnancy at least 37 weeks

Exclusion Criteria

1. platelet count less than 50\*100000000
2. International Normalized Ratio more than 1.5
3. site of puncture with infection
4. with intracranial hypertension
5. with lumbar spine or spinal cord disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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DAN HUANG

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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WEIFENG YU, MD

Role: STUDY_CHAIR

Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Locations

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Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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DAN HUANG, MS

Role: CONTACT

15921108822

JIE ZHOU, MS

Role: CONTACT

13601693227

Facility Contacts

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DAN HUANG, MS

Role: primary

15921108822

JIE ZHOU, MS

Role: backup

13601693227

References

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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.

Reference Type DERIVED
PMID: 30636632 (View on PubMed)

Other Identifiers

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MICS2016033

Identifier Type: -

Identifier Source: org_study_id

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