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Body Mass Index and Post-dural Puncture Headache

S

Sakarya University

Status

Completed

Conditions

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

Treatments

Procedure: spinal anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT02999919
16214662/050.01.04/87

Details and patient eligibility

About

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.

Full 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.

Enrollment

420 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

420 participants in 2 patient groups

BMI ≥ 30
Active Comparator group
Description:
BMI ≥ 30
Treatment:
Procedure: spinal anesthesia
BMI < 30
Active Comparator group
Description:
BMI \<30
Treatment:
Procedure: spinal anesthesia

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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