Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05212194
Other study ID # 2021/10-25
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 15, 2022
Est. completion date September 1, 2022

Study information

Verified date January 2022
Source Adiyaman University Research Hospital
Contact Nezir Yilmaz, Dr
Phone +90 5068939496
Email yilmaznezir@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Post-spinal headache is divided into 3 according to the severity scale. It is divided into 3 groups as mild, moderate and severe according to the presence of symptoms such as nausea, vomiting, and dizziness that prevent daily activity. It has been reported that CSF leakage may be higher due to the weakness of the regional dural sac in primary connective tissue diseases with joint laxity and isolated joint hypermobility. Joint laxity is scored according to the level of motion in 5 different joints and a maximum of 9 points is obtained. In this study, it was aimed to investigate whether joint laxity contributes to the development of post-spinal headache by questioning the correlation between joint laxity examination score and postspinal headache in patients with post-spinal headache.


Description:

Post dural puncture headache (PDPH), also known as post lumbar puncture (LP) headache, is a common complication of diagnostic LP. It also can occur following spinal anesthesia or, more commonly, inadvertent dural puncture during attempted epidural catheter placement. The headache is usually positional (worse when upright, better when lying flat) and is often accompanied by neck stiffness, photophobia, nausea, or subjective hearing symptoms. In various studies, common patient risk factors for PDPH have included female gender, pregnancy, age 18 to 50 years compared with older or younger ages, and a prior history of headache Additionally it has been thought that joint laxity contributes to the development of post dural puncture headache. However, no study has been found in the literature examining this relationship between them. In thıs study it was aimed to investigate the relationship between joint laxity and post dural puncture headache.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date September 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 18-65 age - the patients who develop PDPH Exclusion Criteria: - <18 and >65 age - the patients refused to participate in the study

Study Design


Intervention

Other:
examination
Joint laxity is scored according to the level of motion in 5 different joints and a maximum of 9 points is obtained.

Locations

Country Name City State
Turkey Adiyaman Training and Research Hospital Adiyaman

Sponsors (1)

Lead Sponsor Collaborator
Adiyaman University Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post dural puncture headache (PDPH) severity The patients that occured PDPH will evaluate and classificate as mild,moderate and severe according to severity of PDPH by using Lybecker classification. 24 hours after spinal anesthesia
Primary joint laxity score The Beighton score is a simple system to quantify joint laxity and hypermobility. It uses a simple 9 point system, where the higher the score the higher the laxity. 24 hours after spinal anesthesia
See also
  Status Clinical Trial Phase
Terminated NCT03112720 - Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache Phase 3
Suspended NCT02473276 - 2 Dose Neuraxial Morphine for Prevention of PDPH Phase 4
Completed NCT03652714 - The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache Phase 3
Completed NCT02859233 - Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache N/A
Withdrawn NCT02181205 - Sphenopalatine Ganglion Block for Post-Dural Puncture Headache N/A
Completed NCT01977898 - Incidence of Headache Following an Unintentional Dural Puncture N/A
Withdrawn NCT03966547 - Changes in Cerebral Blood Flow (CBF) in Prone and Sitting Position Before and After GSP-block and Before and After Epidural Blood-patch: A Substudy of NCT03652714 N/A
Terminated NCT02365909 - Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH) Early Phase 1
Completed NCT04910477 - Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache Phase 3
Completed NCT05969119 - Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache Phase 4
Completed NCT02150304 - Aminophylline Prophylaxis For Postdural Puncture Headache N/A
Not yet recruiting NCT04709029 - Effect of Intravenous Versus Intrathecal Dexamethazone on Postdural Puncture Headache N/A
Withdrawn NCT02517931 - Sphenopalatine Ganglion Block for Postdural Puncture Headache in the Emergency Department N/A
Recruiting NCT06271486 - Pregabalin in Treatment of Postdural Puncture Headache Phase 3
Completed NCT00465166 - Lumbar Spine Ultrasound of Patients With Previous Accidental Dural Puncture During Labour Epidural N/A
Completed NCT05777694 - Postdural Punction Headache After Ceserian Section N/A
Withdrawn NCT04515901 - Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches N/A
Completed NCT04892290 - Sphenopalatine Ganglion Block for Postdural Puncture Headache
Completed NCT02394457 - Cosyntropin Versus Epidural Blood Patch (EBP) for Treatment of Treatment of Post Dural Puncture Headache Phase 4
Withdrawn NCT03181464 - Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics Phase 4