Comparison of Two Spinal Needles Regarding Postdural Puncture Headache

January 17, 2014 updated by: Ruslan Abdullayev, Adiyaman University Research Hospital

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

256

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adiyaman, Turkey
        • Adiyaman University Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant female patients between 18-40 years old undergoing cesarean section in Adiyaman University Research Hospital, Turkey.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
26 gauge quincke
Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
26 gauge atraucan
Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adiyaman University Research Hospital

Investigators

  • Principal Investigator: Ruslan Abdullayev, Adiyaman University Research Hospital, Department of Anesthesiology and Reanimation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 27, 2013

First Submitted That Met QC Criteria

March 29, 2013

First Posted (Estimate)

April 1, 2013

Study Record Updates

Last Update Posted (Estimate)

March 6, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDPH 26Q26A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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