The Influence of Needle Diameter on Post Dural Puncture Headache

Helse Nord-Trøndelag HF

Status: Terminated

Conditions: Post-Dural Puncture Headache

Treatments: Device: G27 pencil point needle; Device: G25 pencil point needle

Study type: Interventional

Funder types: Other

Identifiers

NCT02827058

2016/140

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

65 participants in 2 patient groups

G25 pencil point needle

Experimental group

Description:

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

Treatment:

Device: G25 pencil point needle

G27 pencil point needle

Active Comparator group

Description:

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

Treatment:

Device: G27 pencil point needle