The Effect of Patient Position on Postdural Puncture Head... | NCT02122419

Studies
The Effect of Patient Position on Postdural Puncture Headache

NCT02122419

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Status

Completed

Last Update Posted

Aug 5, 2015Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Pregnancy
Headache

Interventions

lateral
sitting

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

May 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Apr 22, 2014

First Submission Date that Met QC Criteria

Apr 23, 2014

First Posted Date

Apr 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2015

Last Update Posted Date

Aug 5, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

İBRAHİM ÖZTÜRK, doctor, Diskapi Yildirim Beyazit Education and Research HospitalPrincipal Investigator

Lead Sponsor

Diskapi Yildirim Beyazit Education and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We aimed to investigate the association between the position in which spinal anesthesia was performed and postdural puncture headache occurrence.

Detailed Description

Records of patients who underwent caesarean section between January, 2013 and November, 2013 with spinal anesthesia will be retrospectively examined. Demographic data of patients, comorbid diseases, position of patient while performing spinal anesthesia, the number of spinal puncture attempts will be recorded.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lateral		spinal anesthesia performed during lateral position	Other: lateral
sitting		spinal anesthesia performed during sitting position	Other: sitting

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lateral	Other	spinal anesthesia performed during lateral position	lateral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postdural puncture headache	patient records will be evaluated regarding post dural puncture headache	postoperative first day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients older than 18 years were included

Exclusion Criteria:

Conversion to general anesthesia was the exclusion criteria.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Patients records form patients who experienced headache after caesarean section with spinal anesthesia were retrospectively evaluated

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ibrahim öztürk, M.D	Ministery of Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dışkapı Yıldırım Beyazıt Education and Research Hospital		Ankara	Ankara	06110	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22473188	Background	Dogan M, Turker H, Ugurlu M, Ergun F, Bozkurt M. Do peroperative supine and prone positions have an effect on postspinal headache incidence? Neurosciences (Riyadh). 2005 Jan;10(1):64-7.
18580174	Background	Gil NS, Lee JH, Yoon SZ, Jeon Y, Lim YJ, Bahk JH. Comparison of thoracic epidural pressure in the sitting and lateral decubitus positions. Anesthesiology. 2008 Jul;109(1):67-71. doi: 10.1097/ALN.0b013e31817b80df.

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D011187	Posture
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena