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

Phase 4Not Yet RecruitingNCT06493838

Minia University180 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

180

Conditions

Acute Pain

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of patients with post dural puncture headache

Number of patients develop post dural puncture headache

Time frame: first 5 days post-partum

Secondary Outcomes

Severity of post dural puncture headache

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

Time frame: first 5 days post-partum

onset and duration of post dural puncture headache

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

Time frame: 5 days post partum

Analgesic request

First time to analgesic request from block

Time frame: 24 hours after operation

Analgesc requirements

Total analgesic requirements

Time frame: 2 days after operation

frequency of analgesic doses

number of analgesic doses given to the patient

Time frame: 5 days

incidence of complications related to the procedure

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

Time frame: 6 hours after procedure

Data from ClinicalTrials.gov

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