Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section

July 1, 2017 updated by: DAN HUANG, RenJi Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, Shanghai Jiao Tong University, School of Medicine
        • Principal Investigator:
          • DAN HUANG, MS
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual analogue score of low back pain
Time Frame: 1 to 7 days after operation
1 to 7 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

December 7, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

July 1, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MICS2016033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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