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Body Mass Index and Post-dural Puncture Headache

NCT ID: NCT02999919

Last Updated: 2016-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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BMI ≥ 30

BMI ≥ 30

Group Type ACTIVE_COMPARATOR

spinal anesthesia

Intervention Type PROCEDURE

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

BMI < 30

BMI \<30

Group Type ACTIVE_COMPARATOR

spinal anesthesia

Intervention Type PROCEDURE

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

Interventions

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spinal anesthesia

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

Intervention Type PROCEDURE

Other Intervention Names

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bupivacaine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sakarya University

OTHER

Sponsor Role lead

Responsible Party

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Serbülent Gökhan BEYAZ

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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16214662/050.01.04/87

Identifier Type: -

Identifier Source: org_study_id