IRCT | Evaluation of the Effect of Sphenopalatine Ganglion Block in the Treatment of Post-Dural Puncture Headache (PDPH) in Patients Undergoing Spinal Anesthesia at Allameh Bohlool Gonabadi Hospital

Protocol summary

Study aim: The effect of sphenopalatine nerve block in the treatment of post-spinal anesthesia headache in patients undergoing spinal anesthesia.
Design: Clinical trial with two control and intervention groups with parallel groups, triple-blind, randomized with sealed envelope, phase 3 on 20 patients
Settings and conduct: Sphenopalatine nerve block is performed transnasally using a cotton swab soaked in 2% lidocaine. The patient is placed in a supine position with the neck slightly bent backward with a pillow or towel. Then, a swab is inserted into the nostril parallel to the floor of the nose until it reaches the posterior nasopharynx, above the middle turbinate. The swab is kept in each nostril for five to ten minutes and then removed. All of these procedures were also performed in group B, except that in this group, the swab is soaked in distilled water instead of lidocaine.
Participants/Inclusion and exclusion criteria: Adult patients aged 18 to 65 years Occurrence of post-dural puncture headache Headache intensity of at least 4 out of 10 based on VAS Patients with stable hemodynamic status at the time of treatment No history of allergy or hypersensitivity to lidocaine No coagulation disorders No active infection or inflammation in the facial or nasal are No peripheral or central nervous system diseases No severe cardiovascular diseases or chronic renal and hepatic failure No receipt of alternative treatments for post-dural puncture headache No mental or psychological disabilities No history of surgery or trauma in the head and face region
Intervention groups: In the intervention group, sphenopalatine block was performed through the nose using a swab soaked in 2% lidocaine In the control group, sphenopalatine block was performed through the nose using a swab soaked in distilled water
Main outcome variables: Headache reduction

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20200501047254N4

Registration date: 2026-02-04, 1404/11/15

Registration timing: registered_while_recruiting

Last update: 2026-02-04, 1404/11/15

Update count: 0
Registration date: 2026-02-04, 1404/11/15

Registrant information: Name

Fatemeh Pouladkhay

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 51 5722 3360

Email address

pouladkhay.fatemeh@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2025-09-23, 1404/07/01
Expected recruitment end date: 2026-04-21, 1405/02/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Evaluation of the Effect of Sphenopalatine Ganglion Block in the Treatment of Post-Dural Puncture Headache (PDPH) in Patients Undergoing Spinal Anesthesia at Allameh Bohlool Gonabadi Hospital

Public title: The effect of sphenopalatine anesthesia in controlling headache after spinal anesthesia.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Headache after spinal anesthesia Headache severity of at least 4 out of 10 on a visual analog pain scale(VAS) Patients with stable hemodynamic status at the time of treatment Informed consent No history of allergy or hypersensitivity to lidocaine No active infection or inflammation in the facial or nasal area (site of sphenopalatine block) No peripheral or central nervous system diseases that could interfere with outcome assessment No severe cardiovascular diseases or chronic renal and hepatic failure No history of surgery or trauma in the head and face region that would limit the safe performance of the block No prior receipt of alternative treatments for post-dural puncture headache (PDPH), such as epidural blood patch, and no need for supplemental treatments during the study Absence of coagulation disorders No mental or psychological disabilities that impair the ability to cooperate or respond to questionnaires

Exclusion criteria:

Unwillingness to continue participating in the research
Age: From 18 years old to 65 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Investigator
Data analyser

Sample size

Target sample size: 20

Randomization (investigator's opinion)

Randomized

Randomization description

For simple randomization of participants into control and intervention groups, individuals will be randomly assigned to one of the two groups using sealed envelopes.

Blinding (investigator's opinion)

Triple blinded

Blinding description

The sampling was conducted in a triple-blind manner such that the swab used for the sphenopalatine block was prepared by a project collaborator, and neither the researcher responsible for sampling nor the patient was aware of the type of medication the swab was impregnated with. Finally, the participants' data in groups A and B were entered into the SPSS software, and the data analyst was blinded to the nature of the groups.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Research Ethics Committees of Gonabad university of medical scienses

Street address

Side of Asian Road - Gonabad University of Medical Sciences Campus

City

Gonabad

Province

Razavi Khorasan

Postal code

9691793718
Approval date: 2025-12-01, 1404/09/10
Ethics committee reference number: IR.GMU.REC.1404.124

Health conditions studied

1

Description of health condition studied: post-dural puncture headache
ICD-10 code: G97.1
ICD-10 code description: Other reaction to spinal and lumbar puncture

Primary outcomes

1

Description: VAS Pain score
Timepoint: Headache measurement before intervention and at 15 and 30 minutes and 1, 2, 4, 6, 8, 12, 24 hours after intervention
Method of measurement: Visual Analogue Scale

Secondary outcomes

1

Description: Tachycardia
Timepoint: heart rate measurement before intervention and at 15 and 30 minutes and 1, 2, 4, 6, 8, 12, 24 hours after intervention
Method of measurement: checklist

Intervention groups

1

Description: Intervention group: Performing a sphenopalatine nerve block under the supervision of an anesthesiologist, transnasally, using a cotton swab soaked in 2% lidocaine.
Category: Treatment - Drugs

2

Description: Control group: Performing a sphenopalatine nerve block under the supervision of an anesthesiologist, transnasally, using a cotton swab soaked in distilled water.
Category: Placebo

Recruitment centers