Comparison of Two Spinal Needles Regarding Postdural Puncture Headache

NCT01821807 | Completed Results

• 1 other identifier: PDPH 26Q26A
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

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. 1.26 Gauge Quincke (cutting-tip needle)
2. 2.26 Gauge Atraucan (atraumatic needle)
3. 3.Number of spinal punctures
4. 4.Time required for the spinal anesthesia procedure
5. 5.Headache
6. 6.Backache

Conditions

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

Keywords

spinal anesthesia; spinal needle; cesarean section; headache; backache

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Backache in Patients Receiving Spinal Anesthesia for Cesarean Section

  1 week

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Adiyaman University Research Hospital: lead

Study Sites (1)

Adiyaman University Research Hospital

Adıyaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Headache; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

We have planned to enroll 150 patients in the Atraucan group, but the circumstances forced us to finish the recruitment at 110.

Results Point of Contact

• Title: Dr. Ruslan Abdullayev
• Organization: Adiyaman University Research Hospital, Department of Anesthesiology and Reanimation

ruslan_jnr@hotmail.com

+905063010833

Study Officials

• Ruslan Abdullayev

  Adiyaman University Research Hospital, Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 1, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 6, 2014
• Results First Posted: December 10, 2013

Record last verified: 2014-01

Locations

TU (1)