Trials / Completed
CompletedNCT05777694
Postdural Punction Headache After Ceserian Section
Investigation of the Effect of Needle Thickness on Postdural Puncture Headache: a Prospective Randomized Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 750 (actual)
- Sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Other Government
- Sex
- Female
- Age
- 20 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The aim of this study is to compare the effect of spinal needle type on postdural puncture headache in patients who will undergo cesarean section. The main question\[s\] it aims to answer are: \[Does spinal needle thickness affect postdural puncture headache?\] \[What is the response of patients who develop postdural puncture headache to treatment?\] In cases accepting cesarean section operation under spinal anesthesia, different tables were used with spinal needles, and it will be questioned whether headache will develop in the first 15 days postoperatively. Postdural puncture headache after surgery will be described.
Detailed description
Our study was designed as a prospective randomized study. Patients aged 20-50 years who accepted cesarean section under elective spinal anesthesia were included in the study. randomized into 3 groups with 250 patients in each group: Group 1: Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle ( Pencan® 0.42 × 88 mm- G27 × 3½, B. Braun, Melsungen, Germany) Group 2: Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle ( Atraucan® 0.42 × 88 mm- G27 × 3½, B. Braun, Melsungen, Germany) Group 3: Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle ( Pencan ® 0.42 × 88 mm- G27 × 3½, B. Braun, Melsungen, Germany) Postdural puncture headache (PDPH) was evaluated by visiting patients who were discharged to the service after spinal anesthesia in the hospital for 24 hours, and by calling them within 15 days after discharge. Conservative and medical treatment was recommended for patients who developed PDPH, and the response of the patients to treatment was evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle | the investigators performed spinal anesthesia with 25 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache |
| PROCEDURE | Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle | the investigators performed spinal anesthesia with 26 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache |
| PROCEDURE | Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle | the investigators performed spinal anesthesia with 27 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache |
Timeline
- Start date
- 2022-02-01
- Primary completion
- 2022-05-01
- Completion
- 2022-05-01
- First posted
- 2023-03-21
- Last updated
- 2023-03-21
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT05777694. Inclusion in this directory is not an endorsement.