- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01821807
Comparison of Two Spinal Needles Regarding Postdural Puncture Headache
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:
- 26 Gauge Quincke (cutting-tip needle)
- 26 Gauge Atraucan (atraumatic needle)
The investigators will observe:
- Number of spinal punctures
- Time required for the spinal anesthesia procedure
Patients will be evaluated after 7 days for:
- Headache
- Backache
Studieoversigt
Status
Detaljeret beskrivelse
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:
- 26 Gauge Quincke (cutting-tip needle)
- 26 Gauge Atraucan (atraumatic needle)
We will observe:
- Number of spinal punctures
- Time required for the spinal anesthesia procedure
Patients will be evaluated after 7 days for:
- Headache
- 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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
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Adiyaman, Kalkun
- Adiyaman University Research Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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26 gauge quincke
Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
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26 gauge atraucan
Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Backache in Patients Receiving Spinal Anesthesia for Cesarean Section
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Ruslan Abdullayev, Adiyaman University Research Hospital, Department of Anesthesiology and Reanimation
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PDPH 26Q26A
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