Clinical Trials Directory

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

TypeNameDescription
PROCEDUREPatients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needlethe investigators performed spinal anesthesia with 25 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
PROCEDUREPatients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needlethe investigators performed spinal anesthesia with 26 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache
PROCEDUREPatients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needlethe 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.