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Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section

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ClinicalTrials.gov Identifier: NCT02987192
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Anticoagulation Minimally Invasive Spinal Anesthesia Device: pen type 27 gauge needles Device: cutting type 22 gauge needles

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Impact Between Minimally Invasive and Traditional Spinal Anesthesia for Cesarean Section in Maternal Anticoagulation Therapy:Randomized Controlled Trial
Study Start Date : November 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: traditional group
Traditional group patients will receive cutting type 22 gauge needles
Device: cutting type 22 gauge needles
traditional group patients will receive cutting type 22 gauge needles.
Experimental: minimally invasive group
minimally invasive group patients will receive pen type 27 gauge needles
Device: pen type 27 gauge needles
minimally invasive group patients will receive pen type 27 gauge needles.


Outcome Measures

Primary Outcome Measures :
  1. Visual analogue score of post-dural puncture headache [ Time Frame: 1 to 7 days after operation ]

Secondary Outcome Measures :
  1. Visual analogue score of low back pain [ Time Frame: 1 to 7 days after operation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987192


Contacts
Contact: DAN HUANG, MS 15921108822 huangdan363@163.com
Contact: JIE ZHOU, MS 13601693227 zhoujie1486@renji.com

Locations
China, Shanghai
Renji Hospital, Shanghai Jiao Tong University, School of Medicine Recruiting
Shanghai, Shanghai, China, 200127
Contact: DAN HUANG, MS    15921108822    huangdan363@163.com   
Contact: JIE ZHOU, MS    13601693227    zhoujie1486@renji.com   
Principal Investigator: DAN HUANG, MS         
Sponsors and Collaborators
RenJi Hospital
Investigators
Study Chair: WEIFENG YU, MD Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine
More Information

Responsible Party: DAN HUANG, Dr., RenJi Hospital
ClinicalTrials.gov Identifier: NCT02987192     History of Changes
Other Study ID Numbers: MICS2016033
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017

Keywords provided by DAN HUANG, RenJi Hospital:
spinal anesthesia
anticoagulation
minimally invasive
Cesarean Section
Maternal