Postdural Puncture Headache After Spinal Anesthesia for Cesarean Section

Assiut University

Status: Not yet enrolling

Conditions: Headache

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT06683807

SM112024

Details and patient eligibility

About

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% .

Full 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,

Enrollment: 55 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 2 patient groups, including a placebo group

Group T0

Placebo Comparator group

Description:

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

Treatment:

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

Group T5

Active Comparator group

Description:

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

Treatment:

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