Effect of Intrathecal Neostigmine on Post-dural Puncture Headache.

The role of Intrathecal Neostigmine as an Adjuvant to Bupivacaine in Ameliorating Post-Dural Puncture Headache for Elective Caesarian Section: A Prospective Randomized Controlled Clinical Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202203682996126

Enrollment

722

Registered

2022-03-23

Start date

2022-04-04

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia

Interventions

Neostigmine group

The control group

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: American society association (ASA) physical status class II parturients with a single fetus who will be scheduled for an elective caesarian section by Intrathecal block.

Exclusion criteria

Exclusion criteria: Body mass index more than or equal to 35 kg/m2. Any contraindication to Intrathecal blocks such as local infection, bleeding disorders, or parturient refusal. Allergy to neostigmine or other drugs will be used in the study. Long-term opioid use. A history of chronic pain, migraine, cluster headache. Digestive problems with nausea and vomiting; cognitive dysfunction or memory disorders. Significant renal, hepatic, and cardiovascular diseases. History of urinary retention or bronchial asthma. Inadequate or failed Intrathecal block. Complicated pregnancy such as hypertensive disorders of the pregnancy, abnormal placenta, or uterine atony.

Design outcomes

Primary

Measure	Time frame
Incidence of post-dural puncture headache	—

Secondary

Measure	Time frame
Age in years;Weight in kilograms (kg);Height in meters (m);Body mass index in kilograms per meter square;Duration of surgical procedure in minutes;The number of intrathecal block attempts.;Post-dural puncture headache (PDPH) severity assessment by Visual Analog Score(VAS). AS 0 = no headache, and 10 = worst imaginable headache.;Neck stiffness incidence.;Percent of participants in need of an epidural blood patch with severe Intractable headache (VAS = 4) and the headache is persistent for more than 48 hours with no response to conservative measures.;The onset of post-dural puncture headache.;Incidence of intraoperative nausea.;Incidence of intraoperative vomiting.;Incidence of postoperative nausea. ;Incidence of postoperative vomiting.;Urine retention incidence.;Memory and cognitive disorders incidence.;Intraoperative hypotension incidence;Intraoperative ephedrine dose requirements in milligrams.;Intraoperative incidence of desaturation.;Intraoperative incidence of respiratory depression. ;Intraoperative incidence of bradycardia.;Intraoperative atropine dose requirements in milligrams. ;Intraoperative incidence of shivering.;Time to the first requirements of analgesics in minutes.;Total analgesic dose consumption in milligrams.;Sensory block onset.;Sensory block duration;Motor block onset. ;Motor block duration.	—

Measure

Time frame

Age in years;Weight in kilograms (kg);Height in meters (m);Body mass index in kilograms per meter square;Duration of surgical procedure in minutes;The number of intrathecal block attempts.;Post-dural puncture headache (PDPH) severity assessment by Visual Analog Score(VAS). AS 0 = no headache, and 10 = worst imaginable headache.;Neck stiffness incidence.;Percent of participants in need of an epidural blood patch with severe Intractable headache (VAS = 4) and the headache is persistent for more than 48 hours with no response to conservative measures.;The onset of post-dural puncture headache.;Incidence of intraoperative nausea.;Incidence of intraoperative vomiting.;Incidence of postoperative nausea. ;Incidence of postoperative vomiting.;Urine retention incidence.;Memory and cognitive disorders incidence.;Intraoperative hypotension incidence;Intraoperative ephedrine dose requirements in milligrams.;Intraoperative incidence of desaturation.;Intraoperative incidence of respiratory depression. ;Intraoperative incidence of bradycardia.;Intraoperative atropine dose requirements in milligrams. ;Intraoperative incidence of shivering.;Time to the first requirements of analgesics in minutes.;Total analgesic dose consumption in milligrams.;Sensory block onset.;Sensory block duration;Motor block onset. ;Motor block duration.

—

Countries

Egypt

Contacts

Public ContactAhmed Alnaggar

Lecturer of Anesthesia and ICU faculty of medicine Alexandria University.

A_elnajjar00@alexmed.edu.eg+201005101836

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026