Effect of Intrathecal Neostigmine on Post-dural Puncture Headache.
Condition: Post-Dural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      Intravenous neostigmine was recently reported as an effective treatment for PDPH for
      parturients after intrathecal (IT) block which is postulated to be through its central
      effects on CSF secretion and cerebral vascular tone modulation. Intrathecal neostigmine has
      been investigated widely and found to be an effective adjuvant to bupivacaine for
      postoperative analgesia.

      The objective of the current study is to investigate the possible prophylactic role of
      intrathecal neostigmine as an adjuvant to bupivacaine in reducing the incidence and severity
      of post-dural puncture headache in parturients scheduled for an elective cesarean section.
    

Detailed description: 
      Upon arrival to the operating room standard monitors will be applied and continued all over
      the operation, an 18G peripheral intravenous (IV) cannula will be inserted, and 15 ml/kg of
      Ringer lactate solution will be infused.

      The intrathecal block will be performed via a midline approach into the L3-4 or L4-5
      interspaces in a sitting position under strict aseptic condition using a 25-gauge spinal
      needle after administration of 3 ml of lidocaine 2% (60 mg) as a subcutaneous infiltration, a
      2.5 ml of hyperbaric bupivacaine, 0.5 % (12.5 mg) in addition to the content of the prepared
      study syringe will be mixed and slowly injected.

      After ensuring sufficient anesthesia level by loss of sensation to pinprick at the T4 level,
      the surgical procedure will start with continuous hemodynamic monitoring and recording.

      At the end of the surgery, the parturient will be transferred to the postoperative anesthesia
      care unit (PACU).

      Parturients will be transferred to the obstetrics ward after fulfilling the criteria of the
      modified Aldrete scoring system ≥9.

      The participants who will be diagnosed to have PDPH Per the previously mentioned criteria
      will be treated by using oral Panadol extra™ (paracetamol 1gm + caffeine 135 mg)
      (Manufactured by: Alexandria company for pharmaceuticals & chemical industries under license:
      GlaxoSmithKline Consumer Healthcare Ltd. Ireland) at 6-hour interval in addition to ensuring
      good oral or intravenous hydration (2-3 L/day) and bed rest. Severe Intractable headache (VAS
      ≥ 4) persistent for more than 48 hours with no response to conservative measures will be
      managed with an autologous epidural blood patch after participant approval and consent
      signing.

      Assessment of the quality of the sensory and motor block in terms of the onset and duration
      will be done at 2 minutes intervals during the first 10 minutes after giving the spinal
      block, then at 10 minutes intervals until the end of the surgery, and at 15 minutes intervals
      while being in the PACU.
    

Intervention name(s): Neostigmine Methylsulfate; Dextrose 5%/Nacl 0.9% Inj
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mg ampule (1 ml) will be diluted in 4 ml dextrose 5% to make a solution of 100 μg/ml, 0.2 ml of this solution will be added to 2.5 ml of hyperbaric bupivacaine 0.5 % used for intrathecal injection.; one ml of normal saline 0.9 % will be mixed with 4 ml dextrose 5 % in the five-milliliter syringe. 0.2 ml of this mixture will be prepared at a one-milliliter identical syringe.
Other intervention name(s): Neostigmine 20 mic; Dextrose 5 %Nacl0.9%
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Neostigmine; Intrathecal; prevention of PDPH; PDPH; Caesarean section