Intrathecal Neostigmine for Prevention of PDPH

• Status: Completed
• Trial end date: 2019-02-10
• Target enrollment: 0
• Participant gender: Female

Summary

Neuraxial blocks continue to be the cornerstone of anesthesia and postoperative analgesia for normal vaginal delivery and elective caesarean section due to its approved safety and efficiency for decades. Post-dural puncture headache (PDPH) is still one of the most common complications of neuraxial anesthetic techniques. The headache could be severe and limit the activities of the new mother to care for her baby, prolong hospital stay.

PDPH is defined as a headache that develops within five days of dural puncture and can't be attributed to any other types of headache and mostly is postural in character.

Neostigmine methylsulfate is a synthetic carbamic acid ester which reversibly inhibits the enzyme Acetylcholine esterase (AChE) that makes more Acetylcholine molecules available at cholinergic receptors. Neostigmine is used in anesthesia mainly as a reversal for non-depolarizing neuromuscular agents.

Intrathecal (IT) neostigmine was tried as an adjuvant to local anesthetics in IT block for elective cesarean sections to decrease local anesthetic consumption and to prolong postoperative analgesia. Side effects of IT neostigmine are dose-dependent with doses more than 25 µg especially nausea and vomiting and could be decreased by increasing the baricities of the local anesthetic solutions and by early head up position after IT injection. However, its effect on PDPH was not investigated before in literature.

Parturients will be randomly assigned into one of two groups: the intervention group will receive 20 µg with IT Bupivacaine and the control group will receive an equivalent volume of dextrose 5% with the IT Bupivacaine.

The objective of the current study is to evaluate the efficacy and safety of IT neostigmine as an adjuvant to bupivacaine in reducing the incidence and severity of post-dural puncture headache in parturients scheduled for an elective cesarean section.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fayoum University Hospital
• Treatments: Bupivacaine; Neostigmine

Criteria

Inclusion Criteria:

• American society association (ASA) physical status II parturients who will be scheduled for an elective caesarean section by IT anesthesia

Exclusion Criteria:

• significant renal, hepatic, and cardiovascular diseases

• pre-eclampsia

• any contraindication to regional anesthesia such as local infection or bleeding disorders

• allergy to neostigmine

• long-term opioid use

• a history of chronic pain, migraine, cluster headache

• digestive problems with nausea or vomiting

• cognitive or memory disorders

• history of urinary retention; bronchial asthma

• perioperative blood transfusion