Anesthesia; Adverse Effect, Spinal and Epidural, Headache, Complications; Anesthesia, Spinal and Epidural, in Pregnancy
Conditions
Keywords
spinal anesthesia, spinal needle, cesarean section, headache, backache
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. 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
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.
Interventions
None listed
Sponsors
Adiyaman University Research Hospital
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Backache in Patients Receiving Spinal Anesthesia for Cesarean Section | 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. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 26 Gauge Quincke Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section. | 150 |
| 26 Gauge Atraucan Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section. | 110 |
| Total | 260 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
Baseline characteristics
| Characteristic | 26 Gauge Atraucan | Total | 26 Gauge Quincke |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 110 Participants | 260 Participants | 150 Participants |
| Age, Continuous | 29.2 years STANDARD_DEVIATION 4.8 | 29.8 years STANDARD_DEVIATION 5.2 | 30.2 years STANDARD_DEVIATION 5.5 |
| Region of Enrollment Turkey | 110 participants | 260 participants | 150 participants |
| Sex: Female, Male Female | 110 Participants | 260 Participants | 150 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 147 | 1 / 109 |
| serious Total, serious adverse events | 79 / 147 | 78 / 109 |
Outcome results
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.
Time frame: 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 26 Gauge Quincke | Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section | 14 participants |
| 26 Gauge Atraucan | Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section | 10 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.
Time frame: 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 26 Gauge Quincke | Backache in Patients Receiving Spinal Anesthesia for Cesarean Section | 65 participants |
| 26 Gauge Atraucan | Backache in Patients Receiving Spinal Anesthesia for Cesarean Section | 68 participants |