Comparison of the Impact Between Minimally Invasive and Traditional Spinal Anesthesia for Cesarean Section in Maternal Anticoagulation Therapy:Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- RenJi Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Visual analogue score of post-dural puncture headache
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
traditional group
Traditional group patients will receive cutting type 22 gauge needles
Intervention: cutting type 22 gauge needles (Device)
minimally invasive group
minimally invasive group patients will receive pen type 27 gauge needles
Intervention: pen type 27 gauge needles (Device)
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)
Investigators
DAN HUANG
Dr.
RenJi Hospital