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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Post-Dural Puncture Headache
• Intervention / Treatment: Drug: normal Saline; Drug: Neostigmine; Drug: Ketorolac

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Ghada Abo Elfadl, MD; Phone Number: 01005802086; Email: ghadafadl77@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Faculty of medicine, Assiut University, Assiut, Egypt,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group C; patients will receive placebo (normal saline)	Drug: normal Saline; patients will receive placebo (normal saline)
Active Comparator: Group N; patients will receive neostigmine (40 μg/kg) plus atropine (20 μg/kg)	Drug: Neostigmine; patients will receive neostigmine (40 μg/kg) plus atropine (20 μg/kg)
Active Comparator: Group K; patients will receive ketorolac (0.5 mg/kg)	Drug: Ketorolac; patients will receive ketorolac (0.5 mg/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postdural puncture headache	the incidence of occurrence of PDPH in patients undergoing infraumbilical surgeries under SA.	1 week

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Kamm K, Forderreuther S. [Post-dural puncture headache]. Schmerz. 2021 Apr;35(2):139-149. doi: 10.1007/s00482-021-00540-x. Epub 2021 Mar 16. German.
• Ljubisavljevic S, Zidverc Trajkovic J. Postdural puncture headache leads to clinical worsening of pre-existing chronic headache. J Clin Neurosci. 2020 May;75:30-34. doi: 10.1016/j.jocn.2020.03.043. Epub 2020 Mar 26.
• Ahmadzade Z, Golparvar M, Sepiani S. Evaluation of the Preventive Effects of Neostigmine Plus Atropine on Post-Dural Puncture Headache. Adv Biomed Res. 2023 May 15;12:119. doi: 10.4103/abr.abr_81_22. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 5, 2025

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 8, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 8, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: ketorolac; Neostigmine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Cholinergic Agents; Parasympathomimetics; Cholinesterase Inhibitors; Ketorolac; Neostigmine
• Other Study ID Numbers: 04-2024-200988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No