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Clinical Trials/NCT02987192
NCT02987192
Unknown
Not Applicable

Comparison of the Impact Between Minimally Invasive and Traditional Spinal Anesthesia for Cesarean Section in Maternal Anticoagulation Therapy:Randomized Controlled Trial

RenJi Hospital1 site in 1 country200 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anticoagulation
Sponsor
RenJi Hospital
Enrollment
200
Locations
1
Primary Endpoint
Visual analogue score of post-dural puncture headache
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
November 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

DAN HUANG

Dr.

RenJi Hospital

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

Outcomes

Primary Outcomes

Visual analogue score of post-dural puncture headache

Time Frame: 1 to 7 days after operation

Secondary Outcomes

  • Visual analogue score of low back pain(1 to 7 days after operation)

Study Sites (1)

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