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
- Conditions
- Acute Pain
- Interventions
- Drug: intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping.
- Registration Number
- NCT06493838
- Lead Sponsor
- Minia University
- Brief Summary
Post dural puncture headache is a distressing issue, many measures tried to treat symptoms but few delt with prevention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 180
- Parturient ladies
- Age ranges from 18 to 35 years old.
- ASA II with elective caesarean section under sub-arachnoid block
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping. intravenous 50 mL of sterile saline 0.9% injection of 0.9% after umbilical cord clamping. Neostgmine group 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. 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 Outcome Measures
Name Time Method Incidence of patients with post dural puncture headache first 5 days post-partum Number of patients develop post dural puncture headache
- Secondary Outcome Measures
Name Time Method Analgesic request 24 hours after operation First time to analgesic request from block
Analgesc requirements 2 days after operation Total analgesic requirements
Severity of post dural puncture headache 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
frequency of analgesic doses 5 days number of analgesic doses given to the patient
incidence of complications related to the procedure 6 hours after procedure number of patients with adverse events as bradycardia, tachcardia, miosis,muscle cramps, twitches, colics, hypotension
onset and duration of post dural puncture headache 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