The Influence of Needle Diameter on Post Dural Puncture Headache

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02827058

Enrollment

Registered

2016-07-11

Start date

2016-03-31

Completion date

2018-05-01

Last updated

2020-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Dural Puncture Headache

Keywords

Delivery, obstetric, Analgesia, Epidural, Injections, Epidural, Needles, Cesarean Section

Brief 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.

Interventions

DEVICEG25 pencil point needle

DEVICEG27 pencil point needle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
number of attempts until successful injection	0 (injection time before delivery)

Secondary

Measure	Time frame
incidence of post dural puncture headache	48 hrs

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026