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NCT02827058 Clinical Trial

The Influence of Needle Diameter on Post Dural Puncture Headache

Post-Dural Puncture Headache Clinical Trial

Official title:
The Influence of Needle Diameter on Needle Failures and Post Dural Puncture Headache in Relation to Cesarean Section and Vaginal Delivery; a Prospective, Randomised Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02827058
Other study ID # 2016/140
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date May 1, 2018

Study information
Verified date April 2020
Source Central Norway Regional Health Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether injection needle pen point type 'PP Gauge 25' should be recommended as a primary choice of needle (in stead of 'PP Gauge 27') for healthy pregnant women who at delivery (vaginal or cesarean section) get spinal anesthesia.

Recruitment information / eligibility
Status Terminated
Enrollment 65
Est. completion date May 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- healthy

- pregnant

- spinal anesthesia at delivery (vaginal delivery or cesarean section emergency grade 2-4)

- informed consent

Exclusion Criteria:

- chronic headache

- (attempt to) epidural anesthesia

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• G25 pencil point needle

• G27 pencil point needle

Locations
Country Name City State
Norway Østfold Hospital Fredrikstad
Norway Levanger Hospital Levanger

Sponsors (2)
Lead Sponsor Collaborator
Central Norway Regional Health Authority Sykehuset Ostfold

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of attempts until successful injection 0 (injection time before delivery)
Secondary incidence of post dural puncture headache 48 hrs
See also
  Status Clinical Trial Phase
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Recruiting NCT05202574 - Comparing the Effects of Ondansetron Versus Dexamethasone on the Incidence of Post-dural Puncture Headache (PDPH) , Nausea and Vomiting After Spinal Anaesthesia of Parturients Undergoing Caesarean Section Phase 2
Terminated NCT02813655 - Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE) Phase 2
Completed NCT02522013 - Aminophylline for Patients With Post-Dural Puncture Headache Phase 3
Recruiting NCT06444737 - Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia N/A
Completed NCT05301387 - The Effect of Ganglion Sphenopalatine Block (GSP-block) Follow-Up
Recruiting NCT05637645 - Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section N/A
Recruiting NCT05116930 - Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture Phase 2
Terminated NCT03430531 - Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache Phase 2
Completed NCT04401878 - SGB in Management of Patients With PDPH Using TCD N/A
Completed NCT04327726 - Effectiveness of Nebulized Dexmedetomidine for Treatment of Obstetric Post-Dural Puncture Headache N/A
Completed NCT03475784 - Two Fluid Strategies for Prevention of Post-dural Puncture Headache Phase 3
Not yet recruiting NCT06272916 - Comparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section.
Completed NCT05262933 - Effects of Preoperative Coffee Consumption in Cesarean Sections Under Spinal Anesthesia
Completed NCT04793490 - Sphenopalatine Ganglion Block for Management of Post- Dural Puncture Headache in Obstetric Patients N/A
Recruiting NCT05888324 - Factors Associated With the Onset of Chronic Headaches in Patients Who Received a Blood Patch in Post Partum
Completed NCT00370604 - Effect of Small Versus Large Epidural Needles on Postdural Puncture Headache Study N/A
Completed NCT04844229 - Bilateral Sphenopalatine Ganglion Block With or Without Bilateral Greater Occipital Nerve Block for Treatment of Obstetric Post-Dural Puncture Headache N/A
Withdrawn NCT03560349 - RCT of SPG Blocks for Post-dural Headache Phase 2
Recruiting NCT06253754 - Pathophysiological Mechanisms and Implication of Treatment in Postural Puncture Headache