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

Post-Dural Puncture Headache Clinical Trial

Official title:

Efficacy and Efficiency of Sphenopalatine Ganglion Block for Management of Post-dural Puncture Headache in Obstetric Patients-A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04793490
• Other study ID #: FMASU R 12/2021
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: December 5, 2021

Study information

• Verified date: March 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 5, 2021
• Est. primary completion date: November 25, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Ganglion Cysts
• Headache
• Post-Dural Puncture Headache
• Wounds and Injuries

Intervention

Procedure:
• 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

Drug:
• paracetamol
patients will receive paracetamol 1 g thrice daily intravenously

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo	Abassia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric rating pain score	Numeric rating pain score will be used to assess the efficacy of SPGB for treatment of PDPH	First 24 hours after the procedure
Secondary	Total analgesic consumption	total dose of ketorolac will be calculated	First 24 hours after the procedure