Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section

Spinal Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02987192
• Other study ID #: MICS2016033
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2016
• Last updated: July 1, 2017
• Start date: November 2016
• Est. completion date: November 2017

Study information

• Verified date: July 2017
• Source: RenJi Hospital
• Contact: DAN HUANG, MS
• Phone: 15921108822
• Email: huangdan363[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulation
• Minimally Invasive
• Spinal Anesthesia

Intervention

Device:
• pen type 27 gauge needles
minimally invasive group patients will receive pen type 27 gauge needles.
• cutting type 22 gauge needles
traditional group patients will receive cutting type 22 gauge needles.

Locations

Country	Name	City	State
China	Renji Hospital, Shanghai Jiao Tong University, School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue score of post-dural puncture headache		1 to 7 days after operation
Secondary	Visual analogue score of low back pain		1 to 7 days after operation