Comparison of Two Spinal Needles Regarding Postdural Puncture Headache

Completed

• Conditions: Complications; Anesthesia, Spinal and Epidural, in Pregnancy; Anesthesia; Adverse Effect, Spinal and Epidural, Headache

• Registration Number: NCT01821807
• Lead Sponsor: Adiyaman University Research Hospital

Brief Summary

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

Detailed Description

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:

1. 26 Gauge Quincke (cutting-tip needle)

2. 26 Gauge Atraucan (atraumatic needle)

We 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

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.

Study Timeline

• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-03-29
• Study First Posted: 2013-04-01
• Study Start: 2013-06
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2013-08-05
• Results First Submitted QC: 2013-10-15
• Results First Posted: 2013-12-10
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-17
• Last Update Posted: 2014-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 256

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section	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 Outcome Measures

Name	Time	Method
Backache in Patients Receiving Spinal Anesthesia for Cesarean Section	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.

Trial Locations

Locations (1)

Adiyaman University Research Hospital; 🇹🇷 Adiyaman, Turkey