Comparison of Two Spinal Needles Regarding Postdural Puncture Headache

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ruslan Abdullayev, Adiyaman University Research Hospital
ClinicalTrials.gov Identifier:
NCT01821807
First received: March 27, 2013
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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

Condition
Anesthesia; Adverse Effect, Spinal and Epidural, Headache
Complications; Anesthesia, Spinal and Epidural, in Pregnancy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Postdural Puncture Headache After Spinal Anesthesia for Cesarean Section, Two Different Needles.

Resource links provided by NLM:


Further study details as provided by Adiyaman University Research Hospital:

Primary Outcome Measures:
  • Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    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:
  • Backache in Patients Receiving Spinal Anesthesia for Cesarean Section [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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.


Enrollment: 256
Study Start Date: June 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821807

Locations
Turkey
Adiyaman University Research Hospital
Adiyaman, Turkey
Sponsors and Collaborators
Adiyaman University Research Hospital
Investigators
Principal Investigator: Ruslan Abdullayev Adiyaman University Research Hospital, Department of Anesthesiology and Reanimation
  More Information

No publications provided

Responsible Party: Ruslan Abdullayev, Dr, Adiyaman University Research Hospital
ClinicalTrials.gov Identifier: NCT01821807     History of Changes
Other Study ID Numbers: PDPH 26Q26A
Study First Received: March 27, 2013
Results First Received: August 5, 2013
Last Updated: January 17, 2014
Health Authority: Turkey: Ethics Committee

Keywords provided by Adiyaman University Research Hospital:
spinal anesthesia
spinal needle
cesarean section
headache
backache

Additional relevant MeSH terms:
Headache
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014