Postdural Puncture Headache After Spinal Anesthesia for Cesarean Section

NCT06683807 | Not Yet Recruiting

• 1 other identifier: SM112024
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

Post-dural puncture headache (PDPH) is a potential and debilitating complication of spinal anesthesia in pregnant patients undergoing caesarean sections (CS), with a reported incidence of 0.5%-2% .

Conditions

Headache

Outcome Measures

Primary Outcomes (1)

• The incidence of post-dural puncture headache (PDPH)

  Assessed using the visual analog score of pain which ranges from 0-10, where 0 = no pain and 10 = maximum worst pain

  The first 120 hours during the post-partum period.

Study Arms (2)

Group T0

PLACEBO COMPARATOR

Parturients will receive spinal anesthesia for elective cesarean delivery with injection of 25 μg fentanyl plus 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 mL) immediately after opening the bupivacaine ampule and directly after immediate aspiration with an unfiltered 3 ml syringe

Drug: Hyperbaric bupivacaine 0.5% (2.5 mL) aspirated immediately after opening the bupivacaine ampule

Group T5

ACTIVE COMPARATOR

Parturients will receive spinal anesthesia for elective cesarean delivery with injection of 25 μg fentanyl plus 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 mL) directly after 5 min' delayed aspiration from opening of the bupivacaine ampule with an unfiltered 3 ml syringe to allow glass particles to settle onto the bottom of the ampule

Drug: Hyperbaric bupivacaine 0.5% (2.5 mL) aspirated 5 minutes delayed after opening the bupivacaine ampule

Interventions

Hyperbaric bupivacaine 0.5% (2.5 mL) aspirated immediately after opening the bupivacaine ampule DRUG

Parturients will receive spinal anesthesia for elective cesarean delivery with injection of 25 μg fentanyl plus 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 mL) immediately after opening the bupivacaine ampule and directly after immediate aspiration with an unfiltered 3 ml syringe

Group T0

Hyperbaric bupivacaine 0.5% (2.5 mL) aspirated 5 minutes delayed after opening the bupivacaine ampule DRUG

Parturients will receive spinal anesthesia for elective cesarean delivery with injection of 25 μg fentanyl plus 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 mL) directly after 5 min' delayed aspiration from opening of the bupivacaine ampule with an unfiltered 3 ml syringe to allow glass particles to settle onto the bottom of the ampule

Group T5

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Parturient with American Society of Anesthesiologists (ASA) class I or II
• Age: 20-45 years old
• A full-term pregnant female undergoing elective cesarean section under spinal anesthesia

You may not qualify if:

• Contraindications to regional anesthesia (coagulopathy, infection at the needle insertion site)
• History of Migraines or persistent headache
• Known hypersensitivity to local anesthetics
• Body mass index (BMI \> 35 kg/m2)
• Hypertensive disorders of pregnancy
• Emergency cesarean section
• Cardiorespiratory, hepatic, or renal impairment
• History of a cerebrovascular accident, neurologic or psychological disorders
• Uncontrolled hypertension
• Spinal column surgery, chronic opioid consumption
• Patients with more than one single attempt and patients with blood loss over 1000 mL who will need additional fluid supplementation or blood transfusion
• Patient refusal

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Seham M Moeen, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seham M Moeen, MD

CONTACT

01006386324; seham.moeen@aun.edu.eg

Esraa A Abdelsamad

CONTACT

01024587718; Esraa.16266100@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Princible investigator

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11