Acute Pain
Conditions
Brief summary
Post dural puncture headache is a distressing issue, many measures tried to treat symptoms but few delt with prevention.
Interventions
DRUGintravenous 50 mL of saline injection of 0.9% after umbilical cord clamping.
intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping.
DRUGNeostigmine 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.
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of patients with post dural puncture headache | first 5 days post-partum | Number of patients develop post dural puncture headache |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Analgesic request | 24 hours after operation | First time to analgesic request from block |
| 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 |
| Analgesc requirements | 2 days after operation | Total analgesic requirements |
Outcome results
None listed