Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section

Shanghai Jiao Tong University

Status: Unknown

Conditions: Anticoagulation; Minimally Invasive; Spinal Anesthesia

Treatments: Device: pen type 27 gauge needles; Device: cutting type 22 gauge needles

Study type: Interventional

Funder types: Other

Identifiers

NCT02987192

MICS2016033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

traditional group

Experimental group

Description:

Traditional group patients will receive cutting type 22 gauge needles

Treatment:

Device: cutting type 22 gauge needles

minimally invasive group

Experimental group

Description:

minimally invasive group patients will receive pen type 27 gauge needles

Treatment:

Device: pen type 27 gauge needles