Comparison of Two Spinal Needles Regarding Postdural Puncture Headache

Complications; Anesthesia, Spinal and Epidural, in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01821807
• Other study ID #: PDPH 26Q26A
• Status: Completed
• Phase: N/A
• First received: March 27, 2013
• Last updated: January 17, 2014
• Start date: June 2013
• Est. completion date: July 2013

Study information

• Verified date: January 2014
• Source: Adiyaman University Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect, Spinal and Epidural, Headache
• Complications; Anesthesia, Spinal and Epidural, in Pregnancy
• Headache
• Post-Dural Puncture Headache

Locations

Country	Name	City	State
Turkey	Adiyaman University Research Hospital	Adiyaman

Sponsors (1)

Lead Sponsor	Collaborator
Adiyaman University Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section	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.	1 week	Yes
Secondary	Backache in Patients Receiving Spinal Anesthesia for Cesarean Section	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.	1 week	No