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NCT Number: NCT06493838

Clinical Efficacy of Prophylactic Intravenous Neostigmine and Atropine in Preventing Post-Dural Puncture Headache Among Parturient Undergoing Spinal Anesthesia for Cesarean Section: A Double-blind Randomized Placebo-controlled Trial

Post dural puncture headache is a distressing issue, many measures tried to treat symptoms but few delt with prevention.

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Key information

Conditions

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

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parturient ladies
  • Age ranges from 18 to 35 years old.
  • ASA II with elective caesarean section under sub-arachnoid block

Exclusion criteria

  • BMI >35
  • Refusal to participate
  • surgical complications necessitating a blood transfusion
  • Emergency caesarean section
  • the need for endotracheal intubation or vasopressors
  • any contraindication to regional anesthesia (such as a history of persistent cephalgia, convulsions, cerebrovascular events

Treatment and study plan

intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping.

Drug

intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping.

Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping.

Drug

Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping.

Primary outcomes

  1. Incidence of patients with post dural puncture headache

    Time frame: first 5 days post-partum

    Number of patients develop post dural puncture headache

Secondary outcomes

  1. Severity of post dural puncture headache

    Time frame: first 5 days post-partum

    Visual analogue scale score for pain assessment. from 0 to ten. 0= no pain 1-3= mild pain....4-6= moderate pain ... 7-10= severe pain

  2. onset and duration of post dural puncture headache

    Time frame: 5 days post partum

    Time when visual analogue scale score increase and duration until return to 0. Visual analogue scale score for pain assessment. from 0 to ten. 0= no pain 1-3= mild pain....4-6= moderate pain ... 7-10= severe pain

  3. Analgesic request

    Time frame: 24 hours after operation

    First time to analgesic request from block

  4. Analgesc requirements

    Time frame: 2 days after operation

    Total analgesic requirements

  5. frequency of analgesic doses

    Time frame: 5 days

    number of analgesic doses given to the patient

  6. incidence of complications related to the procedure

    Time frame: 6 hours after procedure

    number of patients with adverse events as bradycardia, tachcardia, miosis,muscle cramps, twitches, colics, hypotension

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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