Postdural Puncture Headache After Spinal Anesthesia for Cesarean Section

Sponsor
Assiut University
Study ID
NCT06683807
Status
Not Yet Recruiting

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Conditions

  • Headache

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 45 Years
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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% .

Key Dates

First listed
Nov 12, 2024
Start date
Dec 31, 2024
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
55 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Group T0
    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
  • Active Comparator: Group T5
    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 Measure

The incidence of post-dural puncture headache (PDPH) [ Time Frame: The first 120 hours during the post-partum period. ]

Central Contacts

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