Pregnancy Related Clinical Trial
Official title:
Investigation of the Effect of Needle Thickness on Postdural Puncture Headache: a Prospective Randomized Study
NCT number | NCT05777694 |
Other study ID # | 2021-297 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2022 |
Est. completion date | May 1, 2022 |
Verified date | March 2023 |
Source | Bakirkoy Dr. Sadi Konuk Research and Training Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 750 |
Est. completion date | May 1, 2022 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 50 Years |
Eligibility | Inclusion Criteria: - Pregnant women who accept spinal anesthesia and have no contraindications for spinal anesthesia Ages of 20-50 years ASA II-III Exclusion Criteria: - Pregnant women who do not accept spinal anesthesia and who are contraindicated for spinal anesthesia Morbid obesity(BMI>40) Coagulopaty ASA 4 Clinically known local anesthetic allergy |
Country | Name | City | State |
---|---|---|---|
Turkey | Basaksehir Çam and Sakura City Hospital | Istanbul | Basaksehir |
Lead Sponsor | Collaborator |
---|---|
Bakirkoy Dr. Sadi Konuk Research and Training Hospital |
Turkey,
Chekol B, Yetneberk T, Teshome D. Prevalence and associated factors of post dural puncture headache among parturients who underwent cesarean section with spinal anesthesia: A systemic review and meta-analysis, 2021. Ann Med Surg (Lond). 2021 Jun 2;66:1024 — View Citation
Lee SI, Sandhu S, Djulbegovic B, Mhaskar RS. Impact of spinal needle type on postdural puncture headache among women undergoing Cesarean section surgery under spinal anesthesia: A meta-analysis. J Evid Based Med. 2018 Aug;11(3):136-144. doi: 10.1111/jebm. — View Citation
Mowafy SMS, Ellatif SEA. Effectiveness of nebulized dexmedetomidine for treatment of post-dural puncture headache in parturients undergoing elective cesarean section under spinal anesthesia: a randomized controlled study. J Anesth. 2021 Aug;35(4):515-524. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PDPH and spinal needle | The primary aim of this study is to investigate the effect of needle type used on postdural puncture headache. | postoperatively 15 days. The hospital was visited on the first day and information was obtained by calling in the following days. Patients with PDPH were evaluated as mild (1-3), moderate (4-7), severe (8-10) according to the Lybecker classification. | |
Secondary | Treatment response of patients with PDPH | Response rate of patients with PDPH to conservative and medical treatment | postoperatively 15 days, The hospital was visited on the first day and information was obtained by calling in the following days. Oral drugs used in the treatment and recommendations were noted. |
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