Efficacy of Sphenopalatine Block Compared to Blood Patch in the Management of Post-dural Puncture Headaches
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
Post-dural puncture headache (PDPH) is an iatrogenic complication following a dural puncture, which may occur after lumbar puncture, spinal or epidural anesthesia. These headaches are defined as positional headaches, which worsen in the upright position and improve in the supine position, occurring within 5 days after a dural puncture.
PDPH is disabling, particularly in the postpartum period and is often associated with symptoms such as nausea, vomiting, neck stiffness, photophobia, and hearing loss. While serious immediate complications (e.g., subdural hematoma, cerebral venous thrombosis) are rare, long-term consequences - including chronic headaches, neck or low back pain and depression, have been described.
A conservative treatment is usually started during the first 24 hours, but it often proves insufficient, leading to the use of an additional epidural blood patch therapy. While considered as the gold standard, this procedure is invasive and presents limitations. The effectiveness of the epidural blood patch is variable (33-91 %), and the need for a second blood patch is not uncommon. The risks associated with the procedure include second dural puncture, low back pain, vasovagal syncope and paresthesia. Serious complications could occur with reported cases of aseptic meningitis or acute subdural hematoma.
An emerging alternative is the sphenopalatine ganglion block that is a less invasive procedure showing promising results. Several recent trials suggested the safety, feasibilty and efficacy of this intervention with excellent tolerance. Then, we aim to compare the efficacy and safety of these procedures in a randomized controlled trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with post-dural puncture headache meeting the criteria of the International Classification of Headache Disorders (ICHD-3) and persisting after 24 hours of conservative treatment,
Patients aged over 18 years,
Patients affiliated to a social security health insurance system,
Patients who have provided written informed consent.
Disqualifiers
Patients under legal protection (guardianship or curatorship), deprived of liberty (prisoners), or under judicial safeguard,
Pregnant patients,
Patients with hypersensitivity to lidocaine, prilocaine, local anesthetics of the amide type, or to any of the excipients listed in the composition of the drugs used in the protocol,
Patients with acute porphyria, atrioventricular conduction disorders requiring permanent cardiac pacing not yet implemented, or epilepsy not controlled by treatment,
Trial design
Design model
Parallel
Treatments tested in this trial
Sphenopalatine Ganglion Block
DrugThe sphenopalatine ganglion block is performed in the post-anesthesia care unit (PACU). The patient is continuously monitored, including measurement of oxygen saturation, heart rate, and arterial blood pressure. The patient is placed in the supine position with the head extended. The anesthesiologist inserts a cotton-tipped applicator (sterile microbiology swab) soaked with 2.5% lidocaine cream into each nasal cavity until bony contact is reached. Subsequently, 1 mL of 5% injectable lidocaine is administered into each nasal cavity. The cotton-tipped applicators are left in place for 10 minutes and then removed. If headache persists upon patient mobilization to the upright position, the sphenopalatine ganglion block may be repeated a second time.
Blood patch
DrugThe epidural blood patch is performed in the post-anesthesia care unit (PACU). The patient is continuously monitored, with measurement of oxygen saturation, heart rate, and arterial blood pressure. The patient is seated at the edge of the bed, with the anesthesiologist positioned behind the patient. The procedure is carried out in strict adherence to aseptic techniques. The puncture is ideally performed at the L3-L4 or L4-L5 interspace, preferably at or below the level of the initial puncture. Local anesthesia is achieved using 1% injectable lidocaine at the puncture site. The epidural space is identified using the loss-of-resistance technique with saline. Once the epidural space has been identified, peripheral venous blood is collected and slowly injected into the epidural space until the patient reports a sensation of pressure or lumbar pain, with a maximum volume of 30 mL. The patient is then placed in the strict supine position and monitored for at least 30 minutes in the PACU.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Blood patchActive comparator 1 intervention
Group B: Sphenopalatin ganglion blockExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The main objective of our study is to evaluate the efficacy of the sphenopalatine ganglion block in the management of post-dural puncture headache compared to the epidural blood patch.
The primary outcome measure is the evolution of headache intensity in standing position, evaluated using a numerical rating scale \[ranging from 0 (no pain) to 10 (the worst pain ever)\] at the beginning of the intervention, at 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours and 7 days after the performance of a sphenopalatine ganglion block or an epidural blood patch.
Time frame
From the beginning of the intervention to the end of following at 7 daysSecondary outcomes
1
The proportion of patients considered to be in pain
Proportion of patients experiencing pain according to thresholds commonly reported in the literature and evaluated using a numerical rating scale \[ranging from 0 (no pain) to 10 (the worst pain ever)\]
Time frame
At 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days2
Analgesic consumption
Analgesic consumption (paracetamol, nefopam, NSAIDs, opioids) in milligrams after the procedure
Time frame
After the initial procedure to the end of following at 7 days3
The need for rescue therapy
Need for rescue treatment with an epidural blood patch after the initial procedure
Time frame
After the initial procedure to the end of following at 7 days4
Length of hospital stay
Time frame
From enrollment to the end of following at 7 daysSponsors and contacts
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Source ClinicalTrials.gov