Craniotomy SurgeryNCT07886034
Sphenopalatine Ganglion Block Combined With Either Scalp Nerve Block or Local Wound Infiltration for Postoperative Analgesia in Adult Patients Undergoing Craniotomy: A Randomized Controlled Trial
A study testing Group (SS): Sphenopalatine Ganglion Block with either Scalp Nerve Block and Group (SL): patients will receive Sphenopalatine Ganglion Block with local wound infiltration in people with Craniotomy Surgery, run by Zagazig University.
Trial summary
The use of multimodal regional analgesia (scalp block, local scalp infiltration, and sphenopalatine ganglion block) for postoperative pain management after craniotomy Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Craniotomy Surgery
- What is being tested?
- Group (SS): Sphenopalatine Ganglion Block with either Scalp Nerve Block and Group (SL): patients will receive Sphenopalatine Ganglion Block with local wound infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 24 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient acceptance
- Patients age between 21-60 years old.
- Both sexes.
- ASA Physical status II - III.
- BMI ≥ 18 kg/m2 \& ≤ 35 kg/m2.
- Elective craniotomy for supratentorial tumor under general anesthesia.
- Glasgow Coma Scale (GCS) =15.
- Ability of the patient to understand pain assessment score
Who cannot join
- Uncooperative patients.
- Allergy to study local anesthetics.
- patients on antiplatelet, anticoagulant or B blocker
- Pregnancy or lactation.
- Previous surgery affected nasal anatomy.
- Severe hepatic or renal impairment.
- Chronic opioid therapy.
- Previous craniotomy.
About this study
Official title: Sphenopalatine Ganglion Block Combined With Either Scalp Nerve Block or Local Wound Infiltration for PostoperativeZagazig Analgesia in Adult Patients Undergoing Craniotomy: A Randomized Controlled Trial
The use of multimodal regional analgesia (scalp block, local scalp infiltration, and sphenopalatine ganglion block) for postoperative pain management after craniotomy
Read the detailed description
Post-craniotomy pain has often been under-estimated; many patients wake up with moderate to severe pain during the first day after the operation, especially from the skin incision, temporalis muscle handling, and irritation of the periosteum. This pain is usually sharp and localized, and even simple actions like coughing, turning the head, or touching the scalp can make it worse. If this pain is not well controlled, it may raise blood pressure and intracranial pressure, delay neurological assessment, prolong ICU stay, and increase patient stress.
Multimodal regional analgesia is a pain management approach that combines two or more regional anesthesia techniques to target pain from different pathways. Instead of relying solely on systemic medications like opioids, this strategy uses nerve blocks, local infiltration, or other targeted techniques to numb the surgical area, reduce pain signals to the brain, and minimize side effects. The goal is to provide more effective, longer-lasting pain relief while improving patient comfort, reducing anxiety, and supporting faster recovery.
The sphenopalatine ganglion block (SPGB) is a minimally invasive technique performed through the nose, targeting a nerve center involved in cranial pain. Traditionally used for migraines and facial pain, it is now being applied after craniotomy to reduce headache and overall pain. SPGB can lower post-surgery pain, reduce opioid needs, and stabilize blood pressure by affecting central pain.
The scalp nerve block (SNB) is a well-established regional anesthesia technique that targets six paired sensory nerves of the scalp: the supraorbital, supratrochlear, auriculotemporal, zygomaticotemporal, greater occipital, and lesser occipital nerves. By anesthetizing these nerves before incision, SNB significantly reduces nociceptive input from the scalp and periosteum. Clinical studies show that SNB lowers intraoperative hemodynamic surges, decreases opioid requirements, and improves early postoperative pain scores.
Local wound infiltration (LWI) is another commonly used method to manage post-craniotomy pain. The surgeon injects long-acting local anesthetic along the incision line and around the periosteum, directly targeting the area of surgical trauma. It is simple, requires no special equipment, and can be easily done during surgery.
It provides meaningful early postoperative analgesia and reduces the need for strong pain medications. LWI is practical and effective, especially when time or resources limit the use of a fu1ll scalp block.
- Conditions
- Craniotomy Surgery
- Being tested
- Group (c): control group patients will receive general anesthesia., Group (SS): Sphenopalatine Ganglion Block with either Scalp Nerve Block, Group (SL): patients will receive Sphenopalatine Ganglion Block with local wound infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group (c): control group patients will receive general anesthesia.Other
control group patients will receive general anesthesia.
Group (SS): Sphenopalatine Ganglion Block with either Scalp Nerve BlockProcedure or surgery
SPGB will be done as follows (gently place a soft cotton applicator inside the patient's nostril; the cotton is long and thin, like a medical swab, and soaked with 1-2 ml lidocaine 2%for each nostril. The applicator stays in place for about 5-10 minutes for each nostril Then scalp nerve block will be done while the patient is in a supine position. Clean the skin with povidone-iodine. Use a 25G needle for injection of a cocktail of 3mg/kg lidocaine 2%,1mg/kg 0.5% bupivacaine, and 4 mg dexamethasone diluted in 32 ml NS 0.9% to be injected on both sides 16 ml on each side to cover the following nerves
- Supraorbital Nerve Block
- Supratrochlear nerve block
- Zygomaticotemporal nerve block
- Auriculotemporal nerve block
Group (SL): patients will receive Sphenopalatine Ganglion Block with local wound infiltrationProcedure or surgery
SPGB will be done as in group CS, at the end of surgery, local wound infiltration will be done by the surgeon who will inject 3 mg/kg lidocaine 2%,1mg/kg 0.5% bupivacaine, and 4 mg dexamethasone diluted in 32 ml NS 0.9% around the line of surgery
| Study group | Role | What they receive |
|---|---|---|
| Group (c): control group | Other | control group patients will receive general anesthesia Receives: Other: Group (c): control group patients will receive general anesthesia. |
| Group (SS): patients will receive Sphenopalatine Ganglion Block and Scalp Nerve Block | Active comparator | SPGB will be done as follows (gently place a soft cotton applicator inside the patient's nostril; the cotton is long and thin, like a medical swab, and soaked with 1-2 ml lidocaine 2%for each nostril. The applicator stays in place for about 5-10 minutes for each nostril (8).
Then scalp nerve block will be done while the patient is in a supine position. Clean the skin with povidone-iodine. Use a 25G needle for injection of a cocktail of 3mg/kg lidocaine 2%,1mg/kg 0.5% bupivacaine, and 4 mg dexamethasone diluted in 32 ml NS 0.9% to be injected on both sides 16 ml on each side to cover the following nerves (9).
1. Supraorbital Nerve Block
2. Supratrochlear nerve block
3. Zygomaticotemporal nerve block
4. Auriculotemporal nerve block Receives: Procedure: Group (SS): Sphenopalatine Ganglion Block with either Scalp Nerve Block |
| Group (SL): patients will receive Sphenopalatine Ganglion Block with local wound infiltration | Active comparator | SPGB will be done as in group CS, at the end of surgery, local wound infiltration will be done by the surgeon who will inject 3 mg/kg lidocaine 2%,1mg/kg 0.5% bupivacaine, and 4 mg dexamethasone diluted in 32 ml NS 0.9% around the line of surgery Receives: Procedure: Group (SL): patients will receive Sphenopalatine Ganglion Block with local wound infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time interval from patient recovery to the first use of rescue analgesia (nalbuphine)
the time interval between recovery from anesthesia and the need for rescue analgesia
Measured: the first time after recovery from anesthesia when visual analog scale more than or equal 3 at first 24 hours postoperative
Secondary outcomes (3)
post-craniotomy pain
1-Measuring the Intensity of post-craniotomy pain during the first 24 hours after surgery using a validated pain scale as Visual Analog Scale, 0-10, which is a tool used to measure subjective experience of the patient, it consists of 10 cm ranging from zero which equal no pain till 10 which equal severe pain.
Measured: at 0 minutes and 1,2,4,6,8 ,12,18,24 hours postoperative.
Intraoperative patient (Blood Pressure by mmHg )
Intraoperative vital sign of the patients (Blood Pressure by mmHg) will be recorded at baseline (once patient shifted to operating room) and every 5 minutes in the first 30 minute then every 15minutes until the end of surgery
Measured: will be recorded at baseline (once patient shifted to operating room) and every 5 minutes in the first 30 minute then every 15minutes until the end of surgery
Total Dose of rescue analgesia (nalbuphine) mg
Total Dose of rescue analgesia (nalbuphine) by mg used in the first 24 hours will be recorded.
Measured: in the first 24 hours will be recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion24 Mar 2027 (estimated)
- Study completion24 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Craniotomy SurgeryStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Group (c): the control group patient will receive general anesthesia. * Group (SS): patients will receive SPGB with SNB SPGB will be done as follows: gently place a soft cotton applicator inside the patient's nostril; the cotton is long and thin, like a medical swab, and soaked with 1-2 ml lidocaine for each nostril. The applicator stays in place for about 5-10 minutes for each nostril. * Group (SL): patients will receive SPGB with local wound infiltration
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amany Deedamony Said Ahmed Shehata, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886034
- Sponsor's protocol ID
- ZAGAZIG/ANESTHESIA-2026
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Langley GB, Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int. 1985;5(4):145-8. doi: 10.1007/BF00541514.
PubMed 4048757Pini A, Sarafis P, Malliarou M, Tsounis A, Igoumenidis M, Bamidis P, Niakas D. Assessment of patient satisfaction of the quality of health care provided by outpatient services of an oncology hospital. Glob J Health Sci. 2014 Jun 12;6(5):196-203. doi: 10.5539/gjhs.v6n5p196.
PubMed 25169006Gitman M, Fettiplace MR, Weinberg GL, Neal JM, Barrington MJ. Local Anesthetic Systemic Toxicity: A Narrative Literature Review and Clinical Update on Prevention, Diagnosis, and Management. Plast Reconstr Surg. 2019 Sep;144(3):783-795. doi: 10.1097/PRS.0000000000005989.
PubMed 31461049Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
PubMed 4835444Nguyen A, Girard F, Boudreault D, Fugere F, Ruel M, Moumdjian R, Bouthilier A, Caron JL, Bojanowski MW, Girard DC. Scalp nerve blocks decrease the severity of pain after craniotomy. Anesth Analg. 2001 Nov;93(5):1272-6. doi: 10.1097/00000539-200111000-00048.
PubMed 11682413Pinosky ML, Fishman RL, Reeves ST, Harvey SC, Patel S, Palesch Y, Dorman BH. The effect of bupivacaine skull block on the hemodynamic response to craniotomy. Anesth Analg. 1996 Dec;83(6):1256-61. doi: 10.1097/00000539-199612000-00022.
PubMed 8942596Piagkou M, Demesticha T, Troupis T, Vlasis K, Skandalakis P, Makri A, Mazarakis A, Lappas D, Piagkos G, Johnson EO. The pterygopalatine ganglion and its role in various pain syndromes: from anatomy to clinical practice. Pain Pract. 2012 Jun;12(5):399-412. doi: 10.1111/j.1533-2500.2011.00507.x. Epub 2011 Sep 29.
PubMed 21956040Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.
PubMed 37859626. Gupta R, Bogra J, Kothari N. Effect of local anesthetic wound infiltration on postoperative pain and opioid consumption after craniotomy. Journal of Neurosurgical Anesthesiology. (2018);30(2):140-146.
5. Kassem AA, Youssef A, Ahmed N, Mohammed M, Gamal A. Scalp block versus subcutaneous infiltration for stereotactic procedures: randomized comparison. Research and Opinion in Anesthesia & Intensive Care. (2019);6(1):134139. doi: 10.4103/roaic.roaic_24_18.
Yang X, Ma J, Li K, Chen L, Dong R, Lu Y, Zhang Z, Peng M. A comparison of effects of scalp nerve block and local anesthetic infiltration on inflammatory response, hemodynamic response, and postoperative pain in patients undergoing craniotomy for cerebral aneurysms: a randomized controlled trial. BMC Anesthesiol. 2019 Jun 1;19(1):91. doi: 10.1186/s12871-019-0760-4.
PubMed 31153358Mantovani G, Sgarbanti L, Indaimo A, Cavallo MA, De Bonis P, Flacco ME, Scerrati A. Effects of a sphenopalatine ganglion block on postcraniotomy pain management: a randomized, double-blind, clinical trial. Neurosurg Focus. 2023 Dec;55(6):E13. doi: 10.3171/2023.9.FOCUS23549.
PubMed 382620052. Kianian, S., Bansal, J., Lee, C. Perioperative multimodal analgesia: a review of efficacy and safety of the treatment options. APS 2, 9 (2024). https://doi.org/10.1007/s44254-023-00043-.
1. Samagh N, Jangra K, Dey A. Postcraniotomy pain: An update. Journal of Neuroanaesthesiology and Critical Care. (2023); 10(1): 21-30.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphenopalatine Ganglion Block Combined With Either Scalp Nerve Block or Local Wound Infiltration for PostoperativeZagazig Analgesia in Adult Patients Undergoing Craniotomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07886034
- Acronym / sponsor ID
- ZAGAZIG/ANESTHESIA-2026
- Conditions
- Craniotomy Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 24 Mar 2027 (estimated)
- Study completion
- 24 Apr 2027 (estimated)
- First posted
- 21 Oct 2026 (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.
The use of multimodal regional analgesia (scalp block, local scalp infiltration, and sphenopalatine ganglion block) for postoperative pain management after craniotomy
Detailed description
Post-craniotomy pain has often been under-estimated; many patients wake up with moderate to severe pain during the first day after the operation, especially from the skin incision, temporalis muscle handling, and irritation of the periosteum. This pain is usually sharp and localized, and even simple actions like coughing, turning the head, or touching the scalp can make it worse. If this pain is not well controlled, it may raise blood pressure and intracranial pressure, delay neurological assessment, prolong ICU stay, and increase patient stress.
Multimodal regional analgesia is a pain management approach that combines two or more regional anesthesia techniques to target pain from different pathways. Instead of relying solely on systemic medications like opioids, this strategy uses nerve blocks, local infiltration, or other targeted techniques to numb the surgical area, reduce pain signals to the brain, and minimize side effects. The goal is to provide more effective, longer-lasting pain relief while improving patient comfort, reducing anxiety, and supporting faster recovery.
The sphenopalatine ganglion block (SPGB) is a minimally invasive technique performed through the nose, targeting a nerve center involved in cranial pain. Traditionally used for migraines and facial pain, it is now being applied after craniotomy to reduce headache and overall pain. SPGB can lower post-surgery pain, reduce opioid needs, and stabilize blood pressure by affecting central pain.
The scalp nerve block (SNB) is a well-established regional anesthesia technique that targets six paired sensory nerves of the scalp: the supraorbital, supratrochlear, auriculotemporal, zygomaticotemporal, greater occipital, and lesser occipital nerves. By anesthetizing these nerves before incision, SNB significantly reduces nociceptive input from the scalp and periosteum. Clinical studies show that SNB lowers intraoperative hemodynamic surges, decreases opioid requirements, and improves early postoperative pain scores.
Local wound infiltration (LWI) is another commonly used method to manage post-craniotomy pain. The surgeon injects long-acting local anesthetic along the incision line and around the periosteum, directly targeting the area of surgical trauma. It is simple, requires no special equipment, and can be easily done during surgery.
It provides meaningful early postoperative analgesia and reduces the need for strong pain medications. LWI is practical and effective, especially when time or resources limit the use of a fu1ll scalp block.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- * Group (c): the control group patient will receive general anesthesia. * Group (SS): patients will receive SPGB with SNB SPGB will be done as follows: gently place a soft cotton applicator inside the patient's nostril; the cotton is long and thin, like a medical swab, and soaked with 1-2 ml lidocaine for each nostril. The applicator stays in place for about 5-10 minutes for each nostril. * Group (SL): patients will receive SPGB with local wound infiltration
| Arm | Type | Receives |
|---|---|---|
| Group (c): control group | Other | Other: Group (c): control group patients will receive general anesthesia.control group patients will receive general anesthesia |
| Group (SS): patients will receive Sphenopalatine Ganglion Block and Scalp Nerve Block | Active comparator | Procedure: Group (SS): Sphenopalatine Ganglion Block with either Scalp Nerve BlockSPGB will be done as follows (gently place a soft cotton applicator inside the patient's nostril; the cotton is long and thin, like a medical swab, and soaked with 1-2 ml lidocaine 2%for each nostril. The applicator stays in place for about 5-10 minutes for each nostril (8). Then scalp nerve block will be done while the patient is in a supine position. Clean the skin with povidone-iodine. Use a 25G needle for injection of a cocktail of 3mg/kg lidocaine 2%,1mg/kg 0.5% bupivacaine, and 4 mg dexamethasone diluted in 32 ml NS 0.9% to be injected on both sides 16 ml on each side to cover the following nerves (9). 1. Supraorbital Nerve Block 2. Supratrochlear nerve block 3. Zygomaticotemporal nerve block 4. Auriculotemporal nerve block |
| Group (SL): patients will receive Sphenopalatine Ganglion Block with local wound infiltration | Active comparator | Procedure: Group (SL): patients will receive Sphenopalatine Ganglion Block with local wound infiltrationSPGB will be done as in group CS, at the end of surgery, local wound infiltration will be done by the surgeon who will inject 3 mg/kg lidocaine 2%,1mg/kg 0.5% bupivacaine, and 4 mg dexamethasone diluted in 32 ml NS 0.9% around the line of surgery |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patient acceptance
- Patients age between 21-60 years old.
- Both sexes.
- ASA Physical status II - III.
- BMI ≥ 18 kg/m2 \& ≤ 35 kg/m2.
Key exclusion criteria (8 listed)
- Uncooperative patients.
- Allergy to study local anesthetics.
- patients on antiplatelet, anticoagulant or B blocker
- Pregnancy or lactation.
- Previous surgery affected nasal anatomy.
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 |
|---|---|---|
| Group (c): control group patients will receive general anesthesia.control group patients will receive general anesthesia. | Other | Group (c): control group |
| Group (SS): Sphenopalatine Ganglion Block with either Scalp Nerve BlockSPGB will be done as follows (gently place a soft cotton applicator inside the patient's nostril; the cotton is long and thin, like a medical swab, and soaked with 1-2 ml lidocaine 2%for each nostril. The applicator stays in place for about 5-10 minutes for each nostril Then scalp nerve block will be done while the patient is in a supine position. Clean the skin with povidone-iodine. Use a 25G needle for injection of a cocktail of 3mg/kg lidocaine 2%,1mg/kg 0.5% bupivacaine, and 4 mg dexamethasone diluted in 32 ml NS 0.9% to be injected on both sides 16 ml on each side to cover the following nerves 1. Supraorbital Nerve Block 2. Supratrochlear nerve block 3. Zygomaticotemporal nerve block 4. Auriculotemporal nerve block | Procedure or surgery | Group (SS): patients will receive Sphenopalatine Ganglion Block and Scalp Nerve Block |
| Group (SL): patients will receive Sphenopalatine Ganglion Block with local wound infiltrationSPGB will be done as in group CS, at the end of surgery, local wound infiltration will be done by the surgeon who will inject 3 mg/kg lidocaine 2%,1mg/kg 0.5% bupivacaine, and 4 mg dexamethasone diluted in 32 ml NS 0.9% around the line of surgery | Procedure or surgery | Group (SL): patients will receive Sphenopalatine Ganglion Block with local wound infiltration |
Primary outcome
The time interval from patient recovery to the first use of rescue analgesia (nalbuphine)
Time frame: the first time after recovery from anesthesia when visual analog scale more than or equal 3 at first 24 hours postoperative
the time interval between recovery from anesthesia and the need for rescue analgesia
3 secondary outcomes
post-craniotomy pain
Time frame: at 0 minutes and 1,2,4,6,8 ,12,18,24 hours postoperative.
Intraoperative patient (Blood Pressure by mmHg )
Time frame: will be recorded at baseline (once patient shifted to operating room) and every 5 minutes in the first 30 minute then every 15minutes until the end of surgery
Total Dose of rescue analgesia (nalbuphine) mg
Time frame: in the first 24 hours will be recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Results publication: PubMed 4048757Langley GB, Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int. 1985;5(4):145-8. doi: 10.1007/BF00541514.
- Results publication: PubMed 25169006Pini A, Sarafis P, Malliarou M, Tsounis A, Igoumenidis M, Bamidis P, Niakas D. Assessment of patient satisfaction of the quality of health care provided by outpatient services of an oncology hospital. Glob J Health Sci. 2014 Jun 12;6(5):196-203. doi: 10.5539/gjhs.v6n5p196.
- Results publication: PubMed 31461049Gitman M, Fettiplace MR, Weinberg GL, Neal JM, Barrington MJ. Local Anesthetic Systemic Toxicity: A Narrative Literature Review and Clinical Update on Prevention, Diagnosis, and Management. Plast Reconstr Surg. 2019 Sep;144(3):783-795. doi: 10.1097/PRS.0000000000005989.
- Results publication: PubMed 4835444Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
- Results publication: PubMed 11682413Nguyen A, Girard F, Boudreault D, Fugere F, Ruel M, Moumdjian R, Bouthilier A, Caron JL, Bojanowski MW, Girard DC. Scalp nerve blocks decrease the severity of pain after craniotomy. Anesth Analg. 2001 Nov;93(5):1272-6. doi: 10.1097/00000539-200111000-00048.
- Results publication: PubMed 8942596Pinosky ML, Fishman RL, Reeves ST, Harvey SC, Patel S, Palesch Y, Dorman BH. The effect of bupivacaine skull block on the hemodynamic response to craniotomy. Anesth Analg. 1996 Dec;83(6):1256-61. doi: 10.1097/00000539-199612000-00022.
- Results publication: PubMed 21956040Piagkou M, Demesticha T, Troupis T, Vlasis K, Skandalakis P, Makri A, Mazarakis A, Lappas D, Piagkos G, Johnson EO. The pterygopalatine ganglion and its role in various pain syndromes: from anatomy to clinical practice. Pain Pract. 2012 Jun;12(5):399-412. doi: 10.1111/j.1533-2500.2011.00507.x. Epub 2011 Sep 29.
- Results publication: PubMed 3785962Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.
- Results publication6. Gupta R, Bogra J, Kothari N. Effect of local anesthetic wound infiltration on postoperative pain and opioid consumption after craniotomy. Journal of Neurosurgical Anesthesiology. (2018);30(2):140-146.
- Results publication5. Kassem AA, Youssef A, Ahmed N, Mohammed M, Gamal A. Scalp block versus subcutaneous infiltration for stereotactic procedures: randomized comparison. Research and Opinion in Anesthesia & Intensive Care. (2019);6(1):134139. doi: 10.4103/roaic.roaic_24_18.
- Results publication: PubMed 31153358Yang X, Ma J, Li K, Chen L, Dong R, Lu Y, Zhang Z, Peng M. A comparison of effects of scalp nerve block and local anesthetic infiltration on inflammatory response, hemodynamic response, and postoperative pain in patients undergoing craniotomy for cerebral aneurysms: a randomized controlled trial. BMC Anesthesiol. 2019 Jun 1;19(1):91. doi: 10.1186/s12871-019-0760-4.
- Results publication: PubMed 38262005Mantovani G, Sgarbanti L, Indaimo A, Cavallo MA, De Bonis P, Flacco ME, Scerrati A. Effects of a sphenopalatine ganglion block on postcraniotomy pain management: a randomized, double-blind, clinical trial. Neurosurg Focus. 2023 Dec;55(6):E13. doi: 10.3171/2023.9.FOCUS23549.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Group (SS): Sphenopalatine Ganglion Block with either Scalp Nerve Block and Group (SL): patients will receive Sphenopalatine Ganglion Block with local wound infiltration in people with Craniotomy Surgery, run by Zagazig University.
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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
The time interval from patient recovery to the first use of rescue analgesia (nalbuphine) (time frame: the first time after recovery from anesthesia when visual analog scale more than or equal 3 at first 24 hours postoperative). 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 NCT07886034, which also lists 14 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 21 Oct 2026.