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Completed

NCT Number: NCT04844229

Bilateral Sphenopalatine Ganglion Block With or Without Bilateral Greater Occipital Nerve Block for Treatment of Obstetric Post-Dural Puncture Headache

Post-dural puncture headache is a common complication, following neuraxial techniques. The obstetric population is particularly prone to PDPH. Therefore, treatment of PDPH is a key issue in obstetric anesthesia. Conservative treatment for PDPH includes adequate hydration, systemic analgesia with paracetamol and non-steroidal anti-inflammatory drugs and increased caffeine intake, as well as bed rest. If these measures are unsuccessful, the gold standard for the treatment of PDPH is the epidural blood patch which is an invasive technique.

The use of nerve blocks for treating headache symptoms are well known techniques that have been previously used for managing some specific types of chronic headache such as cervicogenic headache, cluster headache, migraine, and occipital neuralgia and there are some recently published studies reporting that these blocks may be beneficial in treating PDPH and the available evidence although showing improvements in the visual analogue (VAS) scores and a reduced number of patients requiring an epidural blood patch, but it is still poor.

Less invasive techniques such as SPG block and GONB are attractive therapeutic options which may eliminate the need for EBP in obstetric patients suffering from PDPH. Up to the best of our knowledge this is the first randomized trial to investigate the analgesic efficacy of adding SPG block either alone or in combination with GONB to PDPH treatment.

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Key information

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University

Zagazig, Sharqia Province, Egypt

About this study

Post-dural puncture headache (PDPH) is a relatively common complication following dural puncture which is more frequently noted in parturients undergoing cesarean section (CS) under neuraxial anesthesia. The mechanism of nociception in PDPH is still indistinct. However, it is thought to be related to the decrease in intracranial pressure caused by the cerebrospinal fluid (CSF) leak through the dural defect leading to a downward pull of intracranial nociceptive structures which is further exacerbated by compensatory cerebral vasodilation. Managing Post-dural Puncture Headache is a challenge for most anesthesiologists as the gold standard and definitive treatment; epidural blood patch (EBP) itself can lead to inadvertent dural puncture that caused the complication in the first place. Medical and conservative management of PDPH may not provide symptomatic relief and anesthesiologists are on a constant lookout for techniques that can provide immediate and sustained relief from this debilitating complication.

The use of regional techniques and nerve blocks for the treatment of headache symptoms are well known techniques. The transnasal sphenopalatine ganglion (SPG) block which is an easy block that requires minimal training was shown to be helpful in the PDPH treatment with promising results. The SPG surrounded by mucous membrane within the posterior nasal turbinate, is a parasympathetic ganglion of cranial nerve (CN) VII which mediates intracranial vasodilation. The role of this block in PDPH management may be due to the vasoconstriction resulting from the parasympathetic block. Additionally, its relationship to the fifth cranial nerve (trigeminal nerve) may simultaneously relieve the frontal headache.

Another regional technique that can be used is the Greater Occipital Nerve Block (GONB) that has been previously used for managing some specific types of chronic headache such as cervicogenic headache, cluster headache, migraine, and occipital neuralgia and there are some recently published studies reporting that GONB may have a beneficial role in PDPH management. In addition, it is a superficial block which can be done at the patient's bedside under ultrasound guidance. The greater occipital nerve is the main sensory nerve of the occipital region that arises from the dorsal ramus of cervical spinal nerve II. The neuromodulation effect together with decreased central sensitivity resulting from meningial and paraspinal muscles irritation as well as blocking the spinal cord dorsal horn afferent fibers may explain the role of GONB in relieving PDPH symptoms. Moreover, the sensitive neurons of the upper cervical cord are close to the trigeminal caudal nucleus. Therefore, its afferences may also be blocked with this technique.

The available evidence of these blocks for treating PDPH although showing improvements in the visual analogue (VAS) scores and a reduced number of patients requiring an epidural blood patch, but it is still poor. Moreover, there are some clinical scenarios in which the patient may refuse treatment with the epidural blood patch, or there may be a contraindication for its use. Hence, we hypothesized those obstetric patients who are particularly prone to PDPH may get benefit from these less invasive techniques and that these blocks may be added to the treatment of patients suffering from PDPH in order to avoid the invasive EBP.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient acceptance.
  • Age 21- 40 years old.
  • Post-partum females suffering PDPH with visual analogue score (VAS) ≥ 4 and modified Lybecker classification score ≥ 2
  • ASA II (due to pregnancy).
  • Body mass index < 35Kg/m2
  • Accepted mental state of the patient.

Exclusion criteria

  • Emergent cesarean section.
  • Hypertensive disorders of the pregnancy.
  • History of allergy to local anesthetics.
  • History of chronic headache, migraine, convulsions, and cerebrovascular accident.
  • Contraindication to spinal anesthesia: coagulopathy, infection at site of injection.
  • Inadequate temporal window

Treatment and study plan

Bilateral transnasal sphenopalatine ganglion block.

Procedure

SPG block will be performed with the patient in supine position using cotton-tipped plastic hollow applicator inserted in the nose with the swab soaked in 1.5 ml 10%lignocaine. The applicator will be inserted parallel to the floor of the nose until resistance encountered. The swab will be rested in the pterygopalatine fossa superior to the middle turbinate and removed after 10 min. This procedure will be repeated in the other nostril too.

Other names: (SPG) block.

Bilateral ultrasound guided greater occipital nerve block.

Procedure

GONB will be performed with the patients lying in prone position using high frequency (6-13 MHz) probe of Siemens Acuson X300 machine placed in transverse orientation lateral to external occipital protuberance parallel to the superior nuchal line to detect occipital artery where the nerve is located medial to it 1.5inch; then 20 gauge needle will be inserted out of plane to avoid vascular injury. 4 ml of treatment solution containing 2.5 mg/ml bupivacaine and 1 mg/ml dexamethasone (prepared by adding 2 ml bupivacaine 0.5% + 1 ml dexamethasone + 1 ml saline) will be injected on each side.

Other names: (GONB).

Primary outcomes

  1. visual analogue scale

    Time frame: 24 hours

    pain score

Secondary outcomes

  1. Trans-Carnial Doppler

    Time frame: 24 hours

    to measure mean flow velocity and the Gosling pulsatility index

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Bilateral Sphenopalatine Ganglion Block With or Without Bilateral Greater Occipital Nerve Block for Treatment of Obstetric Post-Dural Puncture Headache After Spinal Anesthesia

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2021
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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