Trans-nasal Sphenopalatine Ganglion Block Versus Ultrasound-guided Bilateral Greater and Lesser Occipital Nerve Block for Management of Post-Dural Puncture Headache.

NCT ID: NCT06705244

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2024-12-31

Brief Summary

Post-Dural Puncture Headache (PDPH) is a complication associated with spinal anesthesia. While conventional treatments are available, the Epidural Blood Patch (EBP) is considered the gold standard. Other less invasive interventions, such as Sphenopalatine Ganglion (SPG) block and Greater Occipital Nerve (GON) block, have also been used to treat PDPH. The trans-nasal approach is a non-invasive, low-risk technique that can be performed at the bedside without imaging tools.

The Lesser Occipital Nerve Block (LONB) is often used in conjunction with the GONB to address headaches in the lateral occipital region.

This study aims to compare the efficacy of trans-nasal sphenopalatine ganglion block (TNSGB) versus Greater and Lesser Occipital Nerve Block (GALONB) guided by ultrasound in relieving PDPH and its symptoms, as well as to assess patient satisfaction with the interventions.

Conducted at Ain Shams University Hospitals with approval from the medical ethical committee, the study included 50 participants (25 per group) who were ASA class I or II candidates for spinal anesthesia undergoing elective lower abdominal surgeries. Participants were randomly assigned to two groups:

• Group TNSGB: Received a trans-nasal sphenopalatine ganglion block using cotton-tipped applicators inserted trans-nasally until positioned in the posterior nasopharynx.
• Group GALONB: Received a Greater and Lesser Occipital Nerve Block under ultrasound guidance to identify nerves, foramina, vascular structures, and their course.

Patient satisfaction was evaluated using a 5-point Likert scale. The analgesic efficacy of TNSGB versus GALONB was assessed using a Numeric Rating Scale (NRS) at 0, 30 minutes, 1, 2, 3, 6, 12, 24, and 48 hours after treatment.

Adverse events, the need for rescue analgesia, and other therapeutic interventions were also recorded.

Detailed Description

• Type of Study:

Exploratory single-blind randomized comparative trial. (Only the data collection personnel were blinded to the group assignment).

• Study Settings: Ain Shams University Hospitals.

• Study Period:

6 months

• Study Population:

All patients included in this study met the International Headache Society criteria for diagnosis of PDPH, as follows:

1. headache that:

a) worsens within 15 minutes of sitting or standing; b) improves within 15 minutes after lying down; c) must have one of the following associated manifestations of: neck stiffness, tinnitus, hypoacusis, or photophobia;

2. dural puncture has been performed;

3. headache develops within 5 days after dural puncture.

The headache should have persisted for at least two days and must have been intractable to conservative treatment with fluids, caffeine, paracetamol, and other nonopioid analgesics.

Failure of conservative management was defined as headache score > 4/10 on a numerical rating scale (NRS) when the patient assumed an upright position.

-Inclusion Criteria: Physical status: ASA 1 or 2 and candidates for spinal anesthesia undergoing elective lower abdominal surgeries.

Age group: 18-45 years. Sex: Both sexes Body mass index of less than 35 kg/m2 -Exclusion Criteria: Declining to give written informed consent. History of allergy to the medications used in the study. Contraindications to regional anesthesia (including coagulopathy, and local infection).

Psychiatric disorder and/or Drug Addiction. American Society of Anesthesiologists (ASA) Physical Status Class III and more. Moderate to severe hepatic and renal diseases. Emergency surgeries. Nasal septal deviation, Nasal deformity and/or nasal bleeding. Had received opioids less than 12 hours before study inclusion. History of migraines or persistent headaches.

•Sampling Method: Patients fulfilling inclusion criteria will be randomly divided into two groups using their computer-generated random numbers.

•Sampling Size: An exploratory study will be conducted that includes at least 50 participants (25/group) to compare the efficacy of trans-nasal sphenopalatine ganglion block (TNSGB) and greater and lesser occipital nerve block (GALONB) to relieve PDPH and its associated symptoms.

•Ethical Considerations: The study will be performed after ethical committee approval and informed consent from the patients after full explanation of the procedure, possible side effects and complications.

Informed written consent was taken from all patients after explaining the study procedure in detail.

• Study Procedure:

• Pre-operative Settings: All patients will have the same preoperative preparation and anesthetic technique. History and general examination will be done to all patients and routine investigations will be done preoperatively as laboratory investigations (complete blood picture, bleeding time, INR, partial thromboplastin-time, and blood chemistry as liver and kidney function tests). Age, weight, and sex will be recorded.

• Intra-operative Settings: Inside the operating room/ward, intravenous access will be inserted, monitor connected and baseline non-invasive blood pressure (NBP), heart rate (HR), electrocardiography (ECG) and oxygen saturation (SpO2) will be measured.

Patients were randomly allocated into 2 groups.

o TNSPGB Group: The patient was placed supine with shoulders slightly elevated to flex the neck and extend the head.

Then anterior nares were inspected for polyps, tumors, or significant septal deviation.

Long cotton-tipped applicators saturated with lidocaine 2% were inserted into each naris, until properly seated in the posterior nasopharynx.

These were left in place for 10 minutes to lubricate and anesthetize the mucous membrane, making the procedure more comfortable.

Then a mixture of 3 mL of 2 mL lidocaine 2% plus 1 mL dexamethasone 4 mg were injected through the applicators in the sphenopalatine area in each nostril. (Youssef et al., 2021) Then the patient was positioned sitting and pain assessments were recorded. o GALONB Group: The back of the head was sterilized with an antiseptic solution and the landmarks at the base of the skull were identified while the patient in the prone position.

The landmarks were located on the medial third of a line drawn from occipital protuberance to mastoid process. At this level, the greater and lesser occipital nerves lie along the superior nuchal line medial to the occipital artery, halfway between the occipital protuberance and mastoid process.

Under Ultrasound guidance, the skin was infiltrated with 1-2 mL of lidocaine 2%, using a 25-gauge needle. Then the block was performed in this area with a mixture of 3 mL of 2 mL lidocaine 2% plus 1 mL dexamethasone 4 mg to block greater and lesser occipital nerves. Then the procedure was repeated on the other side.

After the procedure, the presence of bilateral occipital numbness was confirmed after 30 minutes. The patient was then positioned sitting and pain scoring was assessed.

*Both blocks will be done and/or supervised by an expert all through.

Conditions

Post-Dural Puncture Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

trans-nasal sphenopalatine ganglion block (TNSGB)

Group Type: ACTIVE_COMPARATOR

Trans-nasal sphenopalatine nerve block

Intervention Type: PROCEDURE

The patient was placed supine with shoulders slightly elevated to flex the neck and extend the head.

Then anterior nares were inspected for polyps, tumors, or significant septal deviation.

Long cotton-tipped applicators saturated with lidocaine 2% were inserted into each naris, until properly seated in the posterior nasopharynx.

These were left in place for 10 minutes to lubricate and anesthetize the mucous membrane, making the procedure more comfortable.

Then a mixture of 3 mL of 2 mL lidocaine 2% plus 1 mL dexamethasone 4 mg were injected through the applicators in the sphenopalatine area in each nostril.

Then the patient was positioned sitting and pain assessments were recorded.

greater and lesser occipital nerve block (GALONB)

Group Type: ACTIVE_COMPARATOR

Greater and lesser occipital nerve block

Intervention Type: PROCEDURE

The back of the head was sterilized with an antiseptic solution and the landmarks at the base of the skull were identified while the patient in the prone position.

The landmarks were located on the medial third of a line drawn from occipital protuberance to mastoid process. At this level, the greater and lesser occipital nerves lie along the superior nuchal line medial to the occipital artery, halfway between the occipital protuberance and mastoid process.

Under Ultrasound guidance, the skin was infiltrated with 1-2 mL of lidocaine 2%, using a 25-gauge needle. Then the block was performed in this area with a mixture of 3 mL of 2 mL lidocaine 2% plus 1 mL dexamethasone 4 mg to block greater and lesser occipital nerves. Then the procedure was repeated on the other side.

After the procedure, the presence of bilateral occipital numbness was confirmed after 30 minutes. The patient was then positioned sitting and pain scoring was assessed.

Interventions

Trans-nasal sphenopalatine nerve block

The patient was placed supine with shoulders slightly elevated to flex the neck and extend the head.

Then anterior nares were inspected for polyps, tumors, or significant septal deviation.

Long cotton-tipped applicators saturated with lidocaine 2% were inserted into each naris, until properly seated in the posterior nasopharynx.

These were left in place for 10 minutes to lubricate and anesthetize the mucous membrane, making the procedure more comfortable.

Then a mixture of 3 mL of 2 mL lidocaine 2% plus 1 mL dexamethasone 4 mg were injected through the applicators in the sphenopalatine area in each nostril.

Then the patient was positioned sitting and pain assessments were recorded.

Intervention Type: PROCEDURE

Greater and lesser occipital nerve block

The back of the head was sterilized with an antiseptic solution and the landmarks at the base of the skull were identified while the patient in the prone position.

The landmarks were located on the medial third of a line drawn from occipital protuberance to mastoid process. At this level, the greater and lesser occipital nerves lie along the superior nuchal line medial to the occipital artery, halfway between the occipital protuberance and mastoid process.

Under Ultrasound guidance, the skin was infiltrated with 1-2 mL of lidocaine 2%, using a 25-gauge needle. Then the block was performed in this area with a mixture of 3 mL of 2 mL lidocaine 2% plus 1 mL dexamethasone 4 mg to block greater and lesser occipital nerves. Then the procedure was repeated on the other side.

After the procedure, the presence of bilateral occipital numbness was confirmed after 30 minutes. The patient was then positioned sitting and pain scoring was assessed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Physical status: ASA 1 or 2 and candidates for spinal anesthesia undergoing elective lower abdominal surgeries.

Age group: 18-45 years. Sex: Both sexes Body mass index of less than 35 kg/m2

Exclusion Criteria

Declining to give written informed consent. History of allergy to the medications used in the study. Contraindications to regional anesthesia (including coagulopathy, and local infection).

Psychiatric disorder and/or Drug Addiction. American Society of Anesthesiologists (ASA) Physical Status Class III and more. Moderate to severe hepatic and renal diseases. Emergency surgeries. Nasal septal deviation, Nasal deformity and/or nasal bleeding. Had received opioids less than 12 hours before study inclusion. History of migraines or persistent headaches.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ain Shams University Hospitals

Cairo, Abbasia, Egypt

Countries

Egypt

References

Uyar Turkyilmaz E, Camgoz Eryilmaz N, Aydin Guzey N, Moraloglu O. Bilateral greater occipital nerve block for treatment of post-dural puncture headache after caesarean operations. Braz J Anesthesiol. 2016 Sep-Oct;66(5):445-50. doi: 10.1016/j.bjane.2015.03.004. Epub 2016 Jan 21.

Reference Type: BACKGROUND

PMID: 27591456 (View on PubMed)

Goncalves LM, Godinho PM, Duran FJ, Valente EC. Sphenopalatine ganglion block by transnasal approach in post-dural puncture headache. J Clin Anesth. 2018 Aug;48:50. doi: 10.1016/j.jclinane.2018.05.006. Epub 2018 May 8. No abstract available.

Reference Type: BACKGROUND

PMID: 29751211 (View on PubMed)

Nair AS, Kodisharapu PK, Anne P, Saifuddin MS, Asiel C, Rayani BK. Efficacy of bilateral greater occipital nerve block in postdural puncture headache: a narrative review. Korean J Pain. 2018 Apr;31(2):80-86. doi: 10.3344/kjp.2018.31.2.80. Epub 2018 Apr 2.

Reference Type: BACKGROUND

PMID: 29686805 (View on PubMed)

Youssef HA, Abdel-Ghaffar HS, Mostafa MF, Abbas YH, Mahmoud AO, Herdan RA. Sphenopalatine Ganglion versus Greater Occipital Nerve Blocks in Treating Post-Dural Puncture Headache after Spinal Anesthesia for Cesarean Section: A Randomized Clinical Trial. Pain Physician. 2021 Jul;24(4):E443-E451.

Reference Type: BACKGROUND

PMID: 34213869 (View on PubMed)

Other Identifiers

FMASU MS141/2024

Identifier Type: -

Identifier Source: org_study_id