Sphenopalatine Ganglion Block for Management of Post- Dural Puncture Headache in Obstetric Patients

NCT ID: NCT04793490

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2021-12-05

Brief Summary

The purpose of this trial is to study the efficacy and efficiency of sphenopalatine ganglion block for management of post dural puncture headache in obstetric patients

Detailed Description

Background and objectives: Post dural puncture headache(PDPH) is a common complication of lumbar puncture, it is likely due to the loss of cerebrospinal fluid into the epidural space through the dural tear. The prevalence of PDPH is higher in pregnant women.Sphenopalatine ganglion block (SPGB) is a non-invasive intervention with minimal adverse effects, it is indicated in acute and chronic facial/head pain like cluster headache, trigeminal neuralgia, post herpetic neuralgia and pain due to head and neck cancer.SPGB can be performed by different approaches:transnasal,transoral ,sub zygomatic and lateral infratemporal.Transnasal is the easiest, least invasive approach which can be done at bedside.

The objective of this trial is to study the efficacy and efficiency of sphenopalatine ganglion block for management of post-dural puncture headache in obstetric patients.The following will be recorded: pain score will be assessed using the numeric rating pain scale(NRS),heart rate and mean arterial pressure, onset and duration of analgesia, total dose of ketorolac, duration of hospital stay and patient satisfaction

Conditions

Post-Dural Puncture Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (Control group)

Patients will receive paracetamol 1 g thrice daily intravenously

Group Type: OTHER

paracetamol

Intervention Type: DRUG

patients will receive paracetamol 1 g thrice daily intravenously

Group B (Sphenopalatine ganglion block group)

patients will receive sphenopalatine ganglion block via transnasal approache by a cotton tipped applicator soaked in 2%lignocaine with 4 mg dexamethasone

Group Type: ACTIVE_COMPARATOR

Sphenopalatine ganglion block

Intervention Type: PROCEDURE

Patients will receive the SPGB via the transnasal approache by a cotton tipped applicator soaked in lignocaine 2% with 4 mg dexamethasone

Interventions

Sphenopalatine ganglion block

Patients will receive the SPGB via the transnasal approache by a cotton tipped applicator soaked in lignocaine 2% with 4 mg dexamethasone

Intervention Type: PROCEDURE

paracetamol

patients will receive paracetamol 1 g thrice daily intravenously

Intervention Type: DRUG

Other Intervention Names

SPGB; acetaminophen

Eligibility Criteria

Inclusion Criteria

• Female patients ASA I or II post caesarean section
• Body weight between 60-100 kg
• Active PDPH within days after spinal anesthesia not relieved with standard treatment such as, intravenous fluids, bed rest and caffeine.

Exclusion Criteria

• Patient refusal to participate in the study
• Body mass index >35kg/m2
• Patients with :coagulopathy ,nasal septal deviation,polyp
• History of nasal bleeding
• Allergy to local anesthetic

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Mostafa Mohamed Ali Mowafi

Lecturer of anesthesia ,principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwa M Mowafi, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University Hospital

Cairo, Abassia, Egypt

Countries

Egypt

Other Identifiers

FMASU R 12/2021

Identifier Type: -

Identifier Source: org_study_id