Bilateral Sphenopalatine Ganglion Block With or Without Bilateral Greater Occipital Nerve Block for Treatment of Obstetric Post-Dural Puncture Headache

NCT04844229 | Completed

• 1 other identifier: 6868
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Post-dural puncture headache is a common complication, following neuraxial techniques. The obstetric population is particularly prone to PDPH. Therefore, treatment of PDPH is a key issue in obstetric anesthesia. Conservative treatment for PDPH includes adequate hydration, systemic analgesia with paracetamol and non-steroidal anti-inflammatory drugs and increased caffeine intake, as well as bed rest. If these measures are unsuccessful, the gold standard for the treatment of PDPH is the epidural blood patch which is an invasive technique. The use of nerve blocks for treating headache symptoms are well known techniques that have been previously used for managing some specific types of chronic headache such as cervicogenic headache, cluster headache, migraine, and occipital neuralgia and there are some recently published studies reporting that these blocks may be beneficial in treating PDPH and the available evidence although showing improvements in the visual analogue (VAS) scores and a reduced number of patients requiring an epidural blood patch, but it is still poor. Less invasive techniques such as SPG block and GONB are attractive therapeutic options which may eliminate the need for EBP in obstetric patients suffering from PDPH. Up to the best of our knowledge this is the first randomized trial to investigate the analgesic efficacy of adding SPG block either alone or in combination with GONB to PDPH treatment.

Conditions

Post-Dural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• visual analogue scale

  pain score

  24 hours

Secondary Outcomes (1)

• Trans-Carnial Doppler

  24 hours

Study Arms (2)

Control group

NO INTERVENTION

21 patients will receive conservative management for PDPH in the form of oral paracetamol 1000 mg/8hours, and caffeine 300-500 mg/day, 1000 mL 0.9% normal saline infusion over the initial 4 hours with increasing oral fluids and bed rest to be maintained. After 6 hour of starting treatment if the above measures failed to control pain with the VAS ≥ 4 non-steroidal anti-inflammatory drugs (NSAID) will be added in the form of ketorolac 30 mg IV which can be repeated every 12 hours if needed. Participants will be followed up after 1 hour, 6 hours and 24 hours with assessment of VAS score, modified Lybecker clas¬sification score and TCD parameters. EBP will be considered after 24 hours of treatment if pain still not controlled with VAS ≥ 4 and modified Lybecker clas¬sification score ≥ 2 and after patients' consent.

Interventional group

ACTIVE COMPARATOR

21 patients will receive the same conservative management as in control group together with bilateral transnasal sphenopalatine ganglion block. After one hour Participants who will show improvement in pain scores will be followed up after 6 hours and 24 hours, while, patients who will show persistent headache will be subjected for bilateral ultrasound guided greater occipital nerve block. then these patients will be assessed after 1 h, 6 h, and 24 h of the block. If still suffering epidural blood patch will be indicated and performed after gaining patients' consent.

Procedure: Bilateral transnasal sphenopalatine ganglion block.; Procedure: Bilateral ultrasound guided greater occipital nerve block.

Interventions

Bilateral transnasal sphenopalatine ganglion block. PROCEDURE

SPG block will be performed with the patient in supine position using cotton-tipped plastic hollow applicator inserted in the nose with the swab soaked in 1.5 ml 10%lignocaine. The applicator will be inserted parallel to the floor of the nose until resistance encountered. The swab will be rested in the pterygopalatine fossa superior to the middle turbinate and removed after 10 min. This procedure will be repeated in the other nostril too.

Also known as: (SPG) block.

Interventional group

Bilateral ultrasound guided greater occipital nerve block. PROCEDURE

GONB will be performed with the patients lying in prone position using high frequency (6-13 MHz) probe of Siemens Acuson X300 machine placed in transverse orientation lateral to external occipital protuberance parallel to the superior nuchal line to detect occipital artery where the nerve is located medial to it 1.5inch; then 20 gauge needle will be inserted out of plane to avoid vascular injury. 4 ml of treatment solution containing 2.5 mg/ml bupivacaine and 1 mg/ml dexamethasone (prepared by adding 2 ml bupivacaine 0.5% + 1 ml dexamethasone + 1 ml saline) will be injected on each side.

Also known as: (GONB).

Interventional group

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient acceptance.
• Age 21- 40 years old.
• Post-partum females suffering PDPH with visual analogue score (VAS) ≥ 4 and modified Lybecker classification score ≥ 2
• ASA II (due to pregnancy).
• Body mass index \< 35Kg/m2
• Accepted mental state of the patient.

You may not qualify if:

• Emergent cesarean section.
• Hypertensive disorders of the pregnancy.
• History of allergy to local anesthetics.
• History of chronic headache, migraine, convulsions, and cerebrovascular accident.
• Contraindication to spinal anesthesia: coagulopathy, infection at site of injection.
• Inadequate temporal window

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University

Zagazig, Sharqia Province, Egypt

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

spirogermanium; Dental Occlusion

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Sherif Mo Mowafy, MD

  Assistant professor of Anesthesia & Surgical Intensive Care Faculty of Medicine - Zagazig University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 14, 2021
• Study Start: June 20, 2021
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Locations

EG (1)