Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section

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.

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

Conditions
-----------------
Anticoagulation, Minimally Invasive, Spinal Anesthesia

Intervention / Treatment
-----------------
* Device: pen type 27 gauge needles
* Device: cutting type 22 gauge needles


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: traditional group<br>Traditional group patients will receive cutting type 22 gauge needles | Device: cutting type 22 gauge needles<br>* traditional group patients will receive cutting type 22 gauge needles.<br>|
| Experimental: minimally invasive group<br>minimally invasive group patients will receive pen type 27 gauge needles | Device: pen type 27 gauge needles<br>* minimally invasive group patients will receive pen type 27 gauge needles.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal anesthesia, anticoagulation, minimally invasive, Cesarean Section, Maternal