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Clinical Trials/NCT02827058
NCT02827058TerminatedNot Applicable

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

Helse Nord-Trøndelag HF3 sites in 1 country65 target enrollmentStarted: March 1, 2016Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
65
Locations
3
Primary Endpoint
number of attempts until successful injection
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •chronic headache
  • •(attempt to) epidural anesthesia

Arms & Interventions

G25 pencil point needle

Experimental

healthy pregnant women who at (vaginal or cesarean section) delivery get spinal anesthesia administered with use of a 25 gauge pencil point needle

Intervention: G25 pencil point needle (Device)

G27 pencil point needle

Active Comparator

healthy pregnant women who at (vaginal or cesarean section) delivery get spinal anesthesia administered with use of a 27 gauge pencil point needle

Intervention: G27 pencil point needle (Device)

Outcomes

Primary Outcomes

number of attempts until successful injection

Time Frame: 0 (injection time before delivery)

Secondary Outcomes

  • incidence of post dural puncture headache(48 hrs)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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