Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02987192

Enrollment

200

Registered

2016-12-08

Start date

2016-11-30

Completion date

2017-11-30

Last updated

2017-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulation, Minimally Invasive, Spinal Anesthesia

Keywords

spinal anesthesia, anticoagulation, minimally invasive, Cesarean Section, Maternal

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.

Interventions

DEVICEpen type 27 gauge needles

minimally invasive group patients will receive pen type 27 gauge needles.

DEVICEcutting type 22 gauge needles

traditional group patients will receive cutting type 22 gauge needles.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Visual analogue score of low back pain	1 to 7 days after operation

Countries

China

Contacts

Primary ContactDAN HUANG, MS

huangdan363@163.com15921108822

Backup ContactJIE ZHOU, MS

zhoujie1486@renji.com13601693227

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026