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Body Mass Index and Post-dural Puncture Headache

Primary Purpose

This Study Investigated the Influence of Body Mass Index (BMI) on PDPH in Elective Caesarean Section Patients in Whom 27G Spinal Needles Were Used

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
spinal anesthesia
Sponsored by
Sakarya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for This Study Investigated the Influence of Body Mass Index (BMI) on PDPH in Elective Caesarean Section Patients in Whom 27G Spinal Needles Were Used

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

(ASA) physical status I-II who underwent elective caesarean section under SA. Women age 18-40 years.

Exclusion Criteria:

  • Who had undergone lumbar disc or vertebra surgery, had chronic low back pain or headache, had contraindications for neuro-axial block, and emergency patients.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    BMI ≥ 30

    BMI < 30

    Arm Description

    BMI ≥ 30

    BMI <30

    Outcomes

    Primary Outcome Measures

    influence of body mass index (BMI) on PDPH in elective caesarean section patients

    Secondary Outcome Measures

    Full Information

    First Posted
    December 18, 2016
    Last Updated
    December 20, 2016
    Sponsor
    Sakarya University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02999919
    Brief Title
    Body Mass Index and Post-dural Puncture Headache
    Official Title
    The Relationship Between Body Mass Index and Post-dural Puncture Headache in Pregnant Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sakarya University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Post-dural puncture headache (PDPH) is seen more frequently in pregnant women due to stress, dehydration, intra-abdominal pressure, and insufficient fluid replacement after delivery. Obesity protects against PDPH in pregnant women; increased intra-abdominal fat tissue reduced cerebrospinal fluid leakage by increasing the pressure in the epidural space. Therefore, this study investigated the influence of body mass index (BMI) on PDPH in elective caesarean section patients in whom 27G spinal needles were used.
    Detailed Description
    The study included 420 women with American Society of Anesthesiology physical status I-II who underwent elective caesarean section under spinal anesthesia. The patients with a BMI less than 30 were accepted as normal weight (Group I) and those with a BMI above 30 were accepted as obese (Group II). Dural puncture performed with a 27G Quincke spinal needle at the L3-4 or L4-5 intervertebral space and given 12.5 mg hyperbaric bupivacaine intrathecally. The patients were questioned regarding headache and low back pain 6, 12, 24, and 48 hours after the procedure, and by phone calls on days 3 and 7.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    This Study Investigated the Influence of Body Mass Index (BMI) on PDPH in Elective Caesarean Section Patients in Whom 27G Spinal Needles Were Used

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    420 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BMI ≥ 30
    Arm Type
    Active Comparator
    Arm Description
    BMI ≥ 30
    Arm Title
    BMI < 30
    Arm Type
    Active Comparator
    Arm Description
    BMI <30
    Intervention Type
    Procedure
    Intervention Name(s)
    spinal anesthesia
    Other Intervention Name(s)
    bupivacaine
    Intervention Description
    12.5 mg hyperbaric bupivacaine intrathecally following a successful dural puncture performed with a 27G Quincke spinal needle at the L3-4 or L4-5 intervertebral space in the sitting position
    Primary Outcome Measure Information:
    Title
    influence of body mass index (BMI) on PDPH in elective caesarean section patients
    Time Frame
    one year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: (ASA) physical status I-II who underwent elective caesarean section under SA. Women age 18-40 years. Exclusion Criteria: Who had undergone lumbar disc or vertebra surgery, had chronic low back pain or headache, had contraindications for neuro-axial block, and emergency patients.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Body Mass Index and Post-dural Puncture Headache

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