Prophylactic Intravenous Injection of Neostigmine Plus Atropine Versus Ketorolac on Post-dural Puncture Headache in Patients Undergoing Infraumbilical Surgeries

Assiut University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Post-Dural Puncture Headache

Treatments: Drug: normal Saline; Drug: Ketorolac; Drug: Neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT06729047

04-2024-200988

Details and patient eligibility

About

Post-dural puncture headache (PDPH) or spinal (or post-spinal) headache is one of the most common side effects of spinal anesthesia, with an incidence of 6-36%. The incidence of this complication was reported to be 76-85% after accidental dural puncture in epidural anesthesia. It usually starts within several hours after spinal anesthesia, but sometimes it can be delayed for up to 2 weeks, which usually resolves within a few days

Full description

The usual symptoms of PDPH other than headache are photophobia, neck stiffness, nausea and vomiting, diplopia, tinnitus, and dizziness. The headache is usually throbbing and severe, starting from the forehead and extending to the occiput, and is aggravated by standing or sitting. This is due to meningeal traction associated with cerebrospinal fluid (CSF) pressure reduction or dilation of cerebral arteries as an indirect effect of lowering CSF pressure as a result of CSF leakage from the punctured dura. Current treatments or preventive measures for PDPH other than bed rest and hydration include theophylline, sumatriptan, caffeine, etc. In resistant or severe cases, epidural blood patch (EBP) is a well-described technique used to provide relief of pain.

The co-administration of neostigmine and atropine is a common treatment for terminating the effects of non-depolarizing muscle relaxants in the setting of general anesthesia with minimal side

Enrollment: 330 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI less than 35 kg/m2
• Scheduled for infraumbilical surgeries
• American Society of Anesthesiologists (ASA) physical status: I and II

Exclusion criteria

1. ASA physical status more than II.
2. History of allrgic response to local anaesthetics or any of the medications used in the study
3. Patients with cognitive impairment
4. pregnancy
5. Basal body temperature of more than 38°C or less than 36°C
6. BMI more than 35 kg/m2

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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330 participants in 3 patient groups, including a placebo group

Group C

Placebo Comparator group

Description:

patients will receive placebo (normal saline)

Treatment:

Drug: normal Saline

Group N

Active Comparator group

Description:

patients will receive neostigmine (40 μg/kg) plus atropine (20 μg/kg)

Treatment:

Drug: Neostigmine

Group K

Active Comparator group

Description:

patients will receive ketorolac (0.5 mg/kg)

Treatment:

Drug: Ketorolac