Post-Dural Puncture HeadacheTNSPGB /GALONBNCT06705244
Trans-nasal Sphenopalatine Ganglion Block Versus Ultrasound-guided Bilateral Greater and Lesser Occipital Nerve Block for Management of Post-Dural Puncture Headache.
A study testing Trans-nasal sphenopalatine nerve block and Greater and lesser occipital nerve block in people with Post-Dural Puncture Headache, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- Trans-nasal sphenopalatine nerve block and Greater and lesser occipital nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Mar 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trans-nasal Sphenopalatine Ganglion Block Versus Ultrasound-guided Bilateral Greater and Lesser Occipital Nerve Block for Management of Post-Dural Puncture Headache After Spinal Anesthesia in Patients Undergoing Lower Abdominal Surgeries
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.
Read more
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.
Read the 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:
- headache that:
- 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;
- dural puncture has been performed;
- 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.
- 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
- Being tested
- Trans-nasal sphenopalatine nerve block, Greater and lesser occipital nerve block
- Keywords
- Post dural Puncture headache, Trans-nasal Sphenopalatine Ganglion Block, Greater Occipital Nerve block, Lesser Occipital Nerve block, Spinal Anesthesia, Pain management, Ultrasound guided nerve blocks
- Medical subject headings
- Post-Dural Puncture Headache, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-nasal sphenopalatine nerve blockProcedure or surgery
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 blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| trans-nasal sphenopalatine ganglion block (TNSGB) | Active comparator | Not described Receives: Procedure: Trans-nasal sphenopalatine nerve block |
| greater and lesser occipital nerve block (GALONB) | Active comparator | Not described Receives: Procedure: Greater and lesser occipital nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patients were asked to evaluate their satisfaction regarding the received intervention through 5-point Likert scale (1 = very satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5= very dissatisfied).
Measured: After 48 hours
Secondary outcomes (2)
the analgesic efficacy of the TNSPGB versus GALONB for treatment of PDPH
using a Numeric Rating Scale (NRS) from 0 to 10
Measured: at baseline 0, at 30 minutes, 1 hour , 2 hours, 3 hours, 6 hours, 12 hours, 24hours and 48 hours after treatment.
Need for rescue analgesia
Need for rescue analgesia If pain score on Numeric rating scale = or > 4
Measured: after 4 hours of given intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start6 Mar 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-Dural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705244
- Sponsor's protocol ID
- FMASU MS141/2024
- Acronym
- TNSPGB /GALONB
- Status last verified
- Feb 2024
- First submitted
- 10 Sep 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27591456Goncalves 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.
PubMed 29751211Nair 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.
PubMed 29686805Youssef 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.
PubMed 34213869
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-nasal Sphenopalatine Ganglion Block Versus Ultrasound-guided Bilateral Greater and Lesser Occipital Nerve Block for Management of Post-Dural Puncture Headache After Spinal Anesthesia in Patients Undergoing Lower Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT06705244
- Acronym / sponsor ID
- TNSPGB /GALONB / FMASU MS141/2024
- Conditions
- Post-Dural Puncture Headache
- Keywords
- Post dural Puncture headache, Trans-nasal Sphenopalatine Ganglion Block, Greater Occipital Nerve block, Lesser Occipital Nerve block, Spinal Anesthesia, Pain management, Ultrasound guided nerve blocks
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- headache that:
- 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;
- dural puncture has been performed;
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trans-nasal sphenopalatine ganglion block (TNSGB) | Active comparator | Procedure: Trans-nasal sphenopalatine nerve block |
| greater and lesser occipital nerve block (GALONB) | Active comparator | Procedure: Greater and lesser occipital nerve block |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-nasal sphenopalatine nerve blockThe 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. | Procedure or surgery | trans-nasal sphenopalatine ganglion block (TNSGB) |
| Greater and lesser occipital nerve blockThe 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. | Procedure or surgery | greater and lesser occipital nerve block (GALONB) |
Primary outcome
Patient satisfaction
Time frame: After 48 hours
Patients were asked to evaluate their satisfaction regarding the received intervention through 5-point Likert scale (1 = very satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5= very dissatisfied).
2 secondary outcomes
the analgesic efficacy of the TNSPGB versus GALONB for treatment of PDPH
Time frame: at baseline 0, at 30 minutes, 1 hour , 2 hours, 3 hours, 6 hours, 12 hours, 24hours and 48 hours after treatment.
Need for rescue analgesia
Time frame: after 4 hours of given intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Background: PubMed 27591456Uyar 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.
- Background: PubMed 29751211Goncalves 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.
- Background: PubMed 29686805Nair 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.
- Background: PubMed 34213869Youssef 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-nasal sphenopalatine nerve block and Greater and lesser occipital nerve block in people with Post-Dural Puncture Headache, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: After 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06705244, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.