Postdural Puncture Headache After Spinal Anesthesia for Cesarean Section

Not Applicable

Not yet recruiting

• Conditions: Headache
• Interventions: Drug: Hyperbaric bupivacaine 0.5% (2.5 mL) aspirated immediately after opening the bupivacaine ampule; Drug: Hyperbaric bupivacaine 0.5% (2.5 mL) aspirated 5 minutes delayed after opening the bupivacaine ampule

• Registration Number: NCT06683807
• Lead Sponsor: Assiut University

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% .

Detailed Description

Various methods for the management of PDPH are present including proper hydration, maintaining a supine posture, caffeine, paracetamol, nonsteroid anti-inflammatory drugs (NSAID), theophylline, opioids like morphine and fentanyl, with the only clearly effective treatment being the epidural blood patch.

Glass particle contamination is known to occur on opening single-dose drug ampoules. Although supporting data are lacking, intrathecal drug administration during subarachnoid blocks and chemotherapy with glass particle contamination is potentially hazardous,

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-09
• Study First Posted: 2024-11-12
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Study Start: 2024-12
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group T0	Hyperbaric bupivacaine 0.5% (2.5 mL) aspirated immediately after opening the bupivacaine ampule	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 T5	Hyperbaric bupivacaine 0.5% (2.5 mL) aspirated 5 minutes delayed after opening the bupivacaine ampule	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

Primary Outcome Measures

Name	Time	Method
The incidence of post-dural puncture headache (PDPH)	The first 120 hours during the post-partum period.	Assessed using the visual analog score of pain which ranges from 0-10, where 0 = no pain and 10 = maximum worst pain