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The Influence of Needle Diameter on Post Dural Puncture Headache

Primary Purpose

Post-Dural Puncture Headache

Status

Terminated

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

G25 pencil point needle

G27 pencil point needle

About this trial

This is an interventional supportive care trial for Post-Dural Puncture Headache focused on measuring Delivery, obstetric, Analgesia, Epidural, Injections, Epidural, Needles, Cesarean Section

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Østfold Hospital
Levanger Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

G25 pencil point needle

G27 pencil point needle

Arm Description

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

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

Outcomes

Primary Outcome Measures

number of attempts until successful injection

Secondary Outcome Measures

incidence of post dural puncture headache

Full Information

NCT ID

NCT02827058

First Posted

July 6, 2016

Last Updated

April 22, 2020

Sponsor

Helse Nord-Trøndelag HF

Collaborators

Sykehuset Ostfold

1. Study Identification

Unique Protocol Identification Number

NCT02827058

Brief Title

The Influence of Needle Diameter on Post Dural Puncture Headache

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Terminated

Why Stopped

due to difficulties recruiting patients and therefore too slow progress

Study Start Date

March 2016 (Actual)

Primary Completion Date

May 1, 2018 (Actual)

Study Completion Date

May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Helse Nord-Trøndelag HF

Collaborators

Sykehuset Ostfold

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Dural Puncture Headache

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

G25 pencil point needle

Arm Type

Experimental

Arm Description

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

Arm Title

G27 pencil point needle

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

G25 pencil point needle

Intervention Type

Device

Intervention Name(s)

G27 pencil point needle

Primary Outcome Measure Information:

Title

number of attempts until successful injection

Time Frame

0 (injection time before delivery)

Secondary Outcome Measure Information:

Title

incidence of post dural puncture headache

Time Frame

48 hrs

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Sverre Vamnes, md

Organizational Affiliation

Østvold Hospital

Official's Role

Study Director

Facility Information:

City

Fredrikstad

Country

Norway

Facility Name

Østfold Hospital

City

Fredrikstad

Country

Norway

Facility Name

Levanger Hospital

City

Levanger

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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The Influence of Needle Diameter on Post Dural Puncture Headache

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