Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-31

Study Completion Date

2022-03-11

Brief Summary

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The objective of the study is to determine the effectiveness of Spheno-Palatine (SP) ganglion block to alleviate the pain of post-dural puncture headache (PDPH).

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Detailed Description

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The primary objectives of the study are to study the effectiveness of SP ganglion block in relieving post-dural puncture headache in terms of :

1. Number of subjects who get relief of pain
2. The onset time to pain relief after application of block
3. The duration of pain relief
4. The incidence of recurrence of post-dural puncture headache

Secondary objectives are to:

1. Monitor any complications due to SP ganglion block
2. Measure patient satisfaction
3. Monitor any residual effects at 1 months after the SP block

Conditions

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Post-Dural Puncture Headache Sphenopalatine Ganglion Block

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label, single arm, pilot study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sphenopalatine ganglion block

Sphenopalatine ganglion block: this block will be performed by inserting swabs, with lidocaine squirted on them, into each nostril and reaching the nasopharyngeal wall.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Lidocaine 2% viscous (0.5ml) will be squirted on two cotton swab sticks and one will be gently inserted into each nostril, along the floor of the nose. Slight rotatory motion of the stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab sticks will be left undisturbed for 5 minutes. The swabs will be taken out and this will be repeated twice more, using fresh swabs and 0.5ml of 2% lidocaine. The block would take about 30 minutes.

Interventions

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Lidocaine

Lidocaine 2% viscous (0.5ml) will be squirted on two cotton swab sticks and one will be gently inserted into each nostril, along the floor of the nose. Slight rotatory motion of the stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab sticks will be left undisturbed for 5 minutes. The swabs will be taken out and this will be repeated twice more, using fresh swabs and 0.5ml of 2% lidocaine. The block would take about 30 minutes.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Complains of symptoms suggestive of post-dural puncture headache
2. Has a history of dural puncture (lumbar puncture or accidental dural puncture during epidural placement) within the previous 7 days
3. Fluent in written and spoken English

Exclusion Criteria

1. Those with a known history of hypersensitivity to local anesthetics of the amide type or to other components of GLYDO
2. Those with any congenital or acquired, anatomical deformity of the nostril, which preclude performing the block
3. Those who refuse to consent to participate in the study
4. Patients who have had a failed epidural blood patch
5. Cognitive Impairment
6. Prisoner

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No