Postdural Punction Headache After Ceserian Section

NCT05777694 | Completed

• 1 other identifier: 2021-297
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postdural Puncture Headache; Regional Anesthesia Morbidity; Pregnancy Related

Keywords

cesarean section; obstetric anesthesia; spinal anaesthesia; postdural punction headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Treatment response of patients with PDPH

  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.

Study Arms (3)

Group 1: 25 gauge spinal needle

ACTIVE COMPARATOR

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)

Procedure: Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle; Procedure: Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle; Procedure: Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle

Group 2: 26 gauge spinal needle

ACTIVE COMPARATOR

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)

Procedure: Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle; Procedure: Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle; Procedure: Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle

Group 3: 27 gauge spina needle

ACTIVE COMPARATOR

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)

Procedure: Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle; Procedure: Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle; Procedure: Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle

Interventions

Patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle PROCEDURE

the investigators performed spinal anesthesia with 25 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache

Group 1: 25 gauge spinal needle; Group 2: 26 gauge spinal needle; Group 3: 27 gauge spina needle

Patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle PROCEDURE

the investigators performed spinal anesthesia with 26 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache

Group 1: 25 gauge spinal needle; Group 2: 26 gauge spinal needle; Group 3: 27 gauge spina needle

Patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle PROCEDURE

the investigators performed spinal anesthesia with 27 gauge pencil point spinal needle to that patient group for prevent postdural puncture headache

Group 1: 25 gauge spinal needle; Group 2: 26 gauge spinal needle; Group 3: 27 gauge spina needle

Eligibility Criteria

• Age: 20 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women who accept spinal anesthesia and have no contraindications for spinal anesthesia Ages of 20-50 years ASA II-III

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Basaksehir, Turkey (Türkiye)

Location

Related Publications (3)

• 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;66:102456. doi: 10.1016/j.amsu.2021.102456. eCollection 2021 Jun.

  PMID: 34141426 RESULT

• 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.12311. Epub 2018 Aug 1.

  PMID: 30070060 RESULT

• 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. doi: 10.1007/s00540-021-02944-6. Epub 2021 May 16.

  PMID: 33993346 RESULT

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Duygu Akyol, M.D

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The prospective randomized study was randomized into 3 groups: 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)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: pospective randomize study

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 21, 2023
• Study Start: February 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)