Trial Outcomes & Findings for Comparison of Two Spinal Needles Regarding Postdural Puncture Headache (NCT NCT01821807)
NCT ID: NCT01821807
Last Updated: 2014-03-06
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
256 participants
Primary outcome timeframe
1 week
Results posted on
2014-03-06
Participant Flow
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".
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
110
|
|
Overall Study
COMPLETED
|
147
|
109
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
Comparison of Two Spinal Needles Regarding Postdural Puncture Headache
Baseline characteristics by cohort
| Measure |
26 Gauge Quincke
n=150 Participants
Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
|
26 Gauge Atraucan
n=110 Participants
Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
150 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
260 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
30.2 years
STANDARD_DEVIATION 5.5 • n=99 Participants
|
29.2 years
STANDARD_DEVIATION 4.8 • n=107 Participants
|
29.8 years
STANDARD_DEVIATION 5.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
260 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Turkey
|
150 participants
n=99 Participants
|
110 participants
n=107 Participants
|
260 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 weekPatients 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.
Outcome measures
| Measure |
26 Gauge Quincke
n=147 Participants
Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
|
26 Gauge Atraucan
n=109 Participants
Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
|
|---|---|---|
|
Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section
|
14 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 1 weekPatients 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.
Outcome measures
| Measure |
26 Gauge Quincke
n=147 Participants
Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
|
26 Gauge Atraucan
n=109 Participants
Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
|
|---|---|---|
|
Backache in Patients Receiving Spinal Anesthesia for Cesarean Section
|
65 participants
|
68 participants
|
Adverse Events
26 Gauge Quincke
Serious events: 79 serious events
Other events: 1 other events
Deaths: 0 deaths
26 Gauge Atraucan
Serious events: 78 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
26 Gauge Quincke
n=147 participants at risk
Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
|
26 Gauge Atraucan
n=109 participants at risk
Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
|
|---|---|---|
|
Nervous system disorders
Postdural puncture headache
|
9.5%
14/147 • Number of events 14 • 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.
|
9.2%
10/109 • Number of events 10 • 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.
|
|
Musculoskeletal and connective tissue disorders
Postdural puncture backache
|
44.2%
65/147 • Number of events 65 • 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.
|
62.4%
68/109 • Number of events 68 • 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.
|
Other adverse events
| Measure |
26 Gauge Quincke
n=147 participants at risk
Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
|
26 Gauge Atraucan
n=109 participants at risk
Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
|
|---|---|---|
|
Cardiac disorders
Sinus rhythm pause
|
0.00%
0/147 • 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.
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Nervous system disorders
Epidural hemathoma
|
0.68%
1/147 • Number of events 1 • 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.
|
0.00%
0/109 • 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.
|
Additional Information
Dr. Ruslan Abdullayev
Adiyaman University Research Hospital, Department of Anesthesiology and Reanimation
Phone: +905063010833
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place