Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section

Sponsor

RenJi Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02987192

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anticoagulation Minimally Invasive Spinal Anesthesia	Device: pen type 27 gauge needles Device: cutting type 22 gauge needles	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

Jul 1, 2017

Anticipated Study Completion Date :

Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: traditional group Traditional group patients will receive cutting type 22 gauge needles	Device: cutting type 22 gauge needles traditional group patients will receive cutting type 22 gauge needles.
Experimental: minimally invasive group minimally invasive group patients will receive pen type 27 gauge needles	Device: pen type 27 gauge needles minimally invasive group patients will receive pen type 27 gauge needles.

Arm

Intervention/Treatment

Experimental: traditional group

Traditional group patients will receive cutting type 22 gauge needles

Device: cutting type 22 gauge needles

traditional group patients will receive cutting type 22 gauge needles.

Experimental: minimally invasive group

minimally invasive group patients will receive pen type 27 gauge needles

Device: pen type 27 gauge needles

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

Outcome Measures

Primary Outcome Measures

Visual analogue score of post-dural puncture headache [1 to 7 days after operation]

Secondary Outcome Measures

Visual analogue score of low back pain [1 to 7 days after operation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renji Hospital, Shanghai Jiao Tong University, School of Medicine	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

RenJi Hospital

Investigators

Study Chair: WEIFENG YU, MD, Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

DAN HUANG, Dr., RenJi Hospital

ClinicalTrials.gov Identifier:

NCT02987192

Other Study ID Numbers:

MICS2016033

First Posted:

Dec 8, 2016

Last Update Posted:

Jul 5, 2017

Last Verified:

Jul 1, 2017

Keywords provided by DAN HUANG, Dr., RenJi Hospital

Study Results

No Results Posted as of Jul 5, 2017