Completed

NCT Number: NCT01821807

Comparison of Two Spinal Needles Regarding Postdural Puncture Headache

The aim of the study is to observe the rate of postdural puncture headache observed after spinal anesthesia in cesarean section patients.

Two kind of spinal anesthesia needles will be used:

1. 26 Gauge Quincke (cutting-tip needle) 2. 26 Gauge Atraucan (atraumatic needle)

The investigators will observe:

1. Number of spinal punctures 2. Time required for the spinal anesthesia procedure

Patients will be evaluated after 7 days for:

1. Headache 2. Backache

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Key information

Conditions

Anesthesia; Adverse Effect, Spinal and Epidural, Headache Back Pain Complications; Anesthesia, Spinal and Epidural, in Pregnancy Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Adiyaman University Research Hospital

Adıyaman, Turkey (Türkiye)

About this study

It is a known phenomenon that spinal anesthesia sometimes results in headache.

The aim of the study is to observe the rate of postdural puncture headache observed after spinal anesthesia in cesarean section patients.

Two kind of spinal anesthesia needles will be used:

26 Gauge Quincke (cutting-tip needle)
26 Gauge Atraucan (atraumatic needle)

We will observe:

Number of spinal punctures
Time required for the spinal anesthesia procedure

Patients will be evaluated after 7 days for:

Headache
Backache

2 kind of spinal anesthesia needles will be used, but no comparison will be made. This is an observational study. Although literature gives different rates of postdural puncture headache for these two needles, we observe the same rate of headache in our clinical practice. We want to define the real rate of postdural puncture headache in patients undergoing cesarean section with spinal anesthesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pregnant female patients between 18-40 years old undergoing cesarean section
Patient accepting spinal anesthesia

Exclusion criteria

Infection at the spinal needle insertion cite
Coagulability disorder
Patient not accepting the procedure

Treatment and study plan

Primary outcomes

Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section

Time frame: 1 week

Patients were observer for the symptoms of headache (PDPH) for 1 week. On the 1st postoperative day they were visited in the clinic. On the 7th postoperative day they were contacted by telephone and were asked about the symptoms.

Secondary outcomes

Backache in Patients Receiving Spinal Anesthesia for Cesarean Section

Time frame: 1 week

Patients were observer for the symptoms of postdural puncture backache for 1 week. On the 1st postoperative day they were visited in the clinic. On the 7th postoperative day they were contacted by telephone and were asked about the symptoms.

Sponsors and collaborators

Lead sponsor

Adiyaman University Research Hospital

Other

Registry information

Official study title

Postdural Puncture Headache After Spinal Anesthesia for Cesarean Section, Two Different Needles.

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Apr 1, 2013
Registry last updated: Mar 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed