Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section

Not Applicable

• Conditions: Minimally Invasive; Spinal Anesthesia; Anticoagulation

• Registration Number: NCT02987192
• Lead Sponsor: RenJi Hospital

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 Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-08
• Status Verified: 2017-07
• Primary Completion: 2017-07
• Last Update Submitted: 2017-07-01
• Last Update Posted: 2017-07-05
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual analogue score of post-dural puncture headache	1 to 7 days after operation

Secondary Outcome Measures

Name	Time	Method
Visual analogue score of low back pain	1 to 7 days after operation

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine; 🇨🇳 Shanghai, Shanghai, China