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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:
The investigators will observe:
Patients will be evaluated after 7 days for:
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:
We will observe:
Patients will be evaluated after 7 days for:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant female patients between 18-40 years old undergoing cesarean section in Adiyaman University Research Hospital, Turkey.
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| Name | Affiliation | Role |
|---|---|---|
| Ruslan Abdullayev | Adiyaman University Research Hospital, Department of Anesthesiology and Reanimation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adiyaman University Research Hospital | Adıyaman | Turkey (Türkiye) |
Non-compliance to the suggestions of the investigators for the part of patients and loss of the contact with the patient were criteria for exclusion.
All the patients in the first month of study were selected in group "Quincke". All the others recruited in the second month of the study were enrolled in group "Atraucan".
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| ID | Title | Description |
|---|---|---|
| FG000 | 26 Gauge Quincke | Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section. |
| FG001 | 26 Gauge Atraucan | Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 26 Gauge Quincke | Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section. |
| BG001 | 26 Gauge Atraucan | Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | 1 week |
|
The patients were observed over one week period. No other extra observation was made as a routine. The stated adverse events had been reported during that time.
One patient had sinus pause, that was observed just few minutes after the local anesthetic application. The second was found to have intracranial epidural hemathoma, that was found on the 1st postoperative day. We have linked it to minor head trauma 3 days before the surgery. The patient had not reported it in the anamnesis prior to the surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 26 Gauge Quincke | Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postdural puncture headache | Nervous system disorders | Systematic Assessment | Postdural puncture headache (PDPH), a common side effect after spinal anesthesia. Can be serious. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus rhythm pause | Cardiac disorders | Non-systematic Assessment | Sinus rhythm cessation for at least 3 seconds. Our patient had 6 second pause. |
We have planned to enroll 150 patients in the Atraucan group, but the circumstances forced us to finish the recruitment at 110.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ruslan Abdullayev | Adiyaman University Research Hospital, Department of Anesthesiology and Reanimation | +905063010833 | ruslan_jnr@hotmail.com |
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| ID | Term |
|---|---|
| D006261 | Headache |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Number | participants | 1 week |
|
|
|
| 79 |
| 147 |
| 1 |
| 147 |
| EG001 | 26 Gauge Atraucan | Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section. | 78 | 109 | 1 | 109 |
|
| Postdural puncture backache | Musculoskeletal and connective tissue disorders | Systematic Assessment | Postdural puncture backache (PDPB), a common side effect after spinal anesthesia. Rarely necessitates intervention. |
|
|
| Epidural hemathoma | Nervous system disorders | Non-systematic Assessment | One patient had experienced intracranial epidural hemathoma. It was linked to the minor head trauma 3 days before the operation, which was missed out in the anamnesis. |
|
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