NCT02999919

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

11 months

First QC Date

December 18, 2016

Last Update Submit

December 20, 2016

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

Outcome Measures

Primary Outcomes (1)

  • influence of body mass index (BMI) on PDPH in elective caesarean section patients

    one year

Study Arms (2)

BMI ≥ 30

ACTIVE COMPARATOR

BMI ≥ 30

Procedure: spinal anesthesia

BMI < 30

ACTIVE COMPARATOR

BMI \<30

Procedure: spinal anesthesia

Interventions

spinal anesthesiaPROCEDURE

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

Also known as: bupivacaine
BMI < 30BMI ≥ 30

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (ASA) physical status I-II who underwent elective caesarean section under SA. Women age 18-40 years.

You may not qualify if:

  • Who had undergone lumbar disc or vertebra surgery, had chronic low back pain or headache, had contraindications for neuro-axial block, and emergency patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Anesthesia, SpinalBupivacaine

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

December 18, 2016

First Posted

December 21, 2016

Study Start

April 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

December 21, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share