Body Mass Index and Post-dural Puncture Headache

The Relationship Between Body Mass Index and Post-dural Puncture Headache in Pregnant Women

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02999919

Enrollment

420

Registered

2016-12-21

Start date

2015-04-30

Completion date

2016-03-31

Last updated

2016-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

PROCEDUREspinal 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame
influence of body mass index (BMI) on PDPH in elective caesarean section patients	one year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026