Body Mass Index and Post-dural Puncture Headache

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02999919
• Other study ID #: 16214662/050.01.04/87
• Status: Completed
• Phase: N/A
• First received: December 18, 2016
• Last updated: December 20, 2016
• Start date: April 2015
• Est. completion date: March 2016

Study information

• Verified date: December 2016
• Source: Sakarya University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	influence of body mass index (BMI) on PDPH in elective caesarean section patients		one year	No