Neostigmine and Atropine for the Treatment of Headache After Dural Puncture Placement

Overview

About this study

The purpose of this study is to evaluate Neostigmine and Glycopyrrolate to treat post-dural puncture headache (PDPH) to reduce the proportion of postpartum women with a PDPH requiring EBP who developed a PDPH after accidental dural puncture with a Tuohy needle.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Post-dural puncture headache (PDPH) after documented dural puncture with Tuohy needle
during placement of epidural analgesia for labor and no other explanation for headache
(HA).

- Onset of HA within 72 hours of delivery.

Exclusion Criteria:

- Patient refusal.

- Visual analog scale (NRS) score < 4.

- History of migraine headaches.

- Asthma.

- Arrhythmia.

- Heart block.

- Myasthenia gravis.

- Inability to understand pain scores and other questionnaires.

- Inability to speak English.

- Contraindication to acetaminophen or NSAIDs.

- Temperature > 38.5 C.

- Prior EBP done for this HA.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/21/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mark Rollins, M.D., Ph.D.

Open for enrollment

Contact information:

Mark Rollins M.D., Ph.D.

(507) 422-0662

Rollins.Mark@mayo.edu

More information

Publications

  • Postdural puncture headache (PDPH) lacks a standard evidence-based treatment. A patient treated with neostigmine for severe PDPH prompted this study. Read More on PubMed
  • Postoperative residual neuromuscular block is a serious threat which endangers the patient safety. Neostigmine has been the most commonly used anticholinesterase for the pharmacological reversal of neuromuscular blockade. Although newer agents have been introduced recently, neostigmine has some irreplaceable advantages, including broad-spectrum reversal of all nondepolarizing neuromuscular blocking drugs, low cost, and availability of more related data for clinical practice to refer to. Neostigmine is also noticed to have some drawbacks, such as the inability to reverse profound and deep blockade, potential induction of muscle weakness, cardiovascular adverse effects, and so on. Data on the usage of neostigmine in the geriatric and the pediatric population are still insufficient. Some discrepancies are observed in the results from previous studies which need further investigation. However, recent studies offer some renewed information. Regarding both efficacy and safety, the key for successful reversal of neuromuscular blockade is to use neostigmine "appropriately," optimizing the dosage and timing of administration under close monitoring. Read More on PubMed
  • One risk with placement of an epidural blood patch (EDBP) is spinal cord or nerve root compression resulting from the epidural blood volume injected, a complication necessitating immediate surgical decompression. We could not find a previous report of this in the literature. Here, we review and discuss one such case. Read More on PubMed
  • This is an analytic, interventional, cross sectional study to evaluate the risk factors of post-dural (post-lumbar) puncture headache (PDPH) and the validity of the diagnostic criteria for PDPH from the ICHD II. Read More on PubMed
  • Sugammadex is the first selective relaxant binding agent that has been studied for reversal of neuromuscular blockade induced by rocuronium and other steroidal non-depolarizing neuromuscular blocking agents (NMBAs). Read More on PubMed
  • Spinal anaesthesia developed in the late 1800s with the work of Wynter, Quincke and Corning. However, it was the German surgeon, Karl August Bier in 1898, who probably gave the first spinal anaesthetic. Bier also gained first-hand experience of the disabling headache related to dural puncture. He correctly surmised that the headache was related to excessive loss of cerebrospinal fluid (CSF). In the last 50 yr, the development of fine-gauge spinal needles and needle tip modification, has enabled a significant reduction in the incidence of post-dural puncture headache. Though it is clear that reducing the size of the dural perforation reduces the loss of CSF, there are many areas regarding the pathogenesis, treatment and prevention of post-dural puncture headache that remain contentious. How does the microscopic pattern of collagen alignment in the spinal dura affect the dimensions of the dural perforation? How do needle design, size and orientation influence leakage of CSF through the dural perforation? Can pharmacological methods reduce the symptoms of post-dural puncture headache? By which mechanism does the epidural blood patch cure headache? Is there a role for the prophylactic epidural blood patch? Do epidural saline, dextran, opioids and tissue glues reduce the rate of CSF loss? This review considers these contentious aspects of post-dural puncture headache. Read More on PubMed
  • Spinal anaesthesia was performed on 247 young adult patients with a 25-G needle. Rectal administration of indomethacin had no significant effect on the incidence of postdural puncture headache, which occurred in 16.8% of patients who received the drug compared to 24.5% who received a placebo. A history of headache pre-operatively did not influence the incidence of postlumbar puncture headache. Read More on PubMed
  • Atropine and glycopyrrolate were compared in a mixture with neostigmine for reversal of neuromuscular blockade in patients undergoing open heart surgery. In patients not receiving beta-blocking drugs, glycopyrrolate was shown to possess advantages over atropine in terms of a lower initial increase in heart rate, better protection against the muscarinic effects of neostigmine, and smaller increases in rate-pressure product. The concomitant administration of beta-adrenergic blocking therapy significantly attenuated the effect of reversal on heart rate and the differences between atropine and glycopyrrolate were not significant. There was no difference in the incidence of arrhythmias between patients who received beta-blocking drugs and those who did not. Read More on PubMed
  • Epidural blood patch (EBP) was performed for the treatment of severe postlumbar puncture cephalalgia in 118 young patients. Following the first EBP, 105 patients had relief of headache. Eleven of the 13 in whom it failed had a second EBP, with adequate relief in 10, giving an overall success of 97.5 percent. Lumbar epidural, caudal, and spinal procedures were successful in 3 patients 105 to 380 days after EBP. Soon after EBP, one patient developed facial paralysis and one complained of episodes of vertigo, dizziness, tinnitus, and ataxia without headaches. Residual complications included backache and/or back stiffness in 22 patients and paresthesia in two. Two-year follow-up revealed 95 percent patient acceptance of the procedure. EBP was found to be a safe, effective method for treating severe postlumbar puncture cephalalgia, provided a proper diagnosis is made and there is no contraindication. Read More on PubMed
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CLS-20523446

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