Body Mass Index and Post-dural Puncture Headache

Not Applicable

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
• Interventions: Procedure: spinal anesthesia

• Registration Number: NCT02999919
• Lead Sponsor: Sakarya University

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.

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-12
• Study First Submitted: 2016-12-18
• Study First Submitted QC: 2016-12-20
• Last Update Submitted: 2016-12-20
• Study First Posted: 2016-12-21
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 420

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMI ≥ 30	spinal anesthesia	BMI ≥ 30
BMI < 30	spinal anesthesia	BMI \<30

Primary Outcome Measures

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