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
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
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
NCT ID
NCT02999919
First Posted
December 18, 2016
Last Updated
December 20, 2016
Sponsor
Sakarya University
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
Learn more about this trial
Body Mass Index and Post-dural Puncture Headache
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