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Not yet recruitingNCT07886034Updated Oct 21, 2026

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

An interventional study of Group (c): control group patients will receive general anesthesia. and Group (SS): Sphenopalatine Ganglion Block with either Scalp Nerve Block in Craniotomy Surgery, sponsored by Zagazig University. Not yet recruiting. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Zagazig University · Not applicable, Interventional, and Other

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Craniotomy Surgery
03

In context

Lead sponsor

Zagazig University is the lead sponsor of 457 studies on the registry; 77 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
54 participants (estimated)

Study arms

  • Other
    Group (c): control group

    control group patients will receive general anesthesia

    Other: Group (c): control group patients will receive general anesthesia.

  • Active comparator
    Group (SS): patients will receive Sphenopalatine Ganglion Block and Scalp Nerve Block

    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

    Procedure: Group (SS): Sphenopalatine Ganglion Block with either Scalp Nerve Block

  • Active comparator
    Group (SL): patients will receive Sphenopalatine Ganglion Block with local wound infiltration

    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

    Procedure: Group (SL): patients will receive Sphenopalatine Ganglion Block with local wound infiltration

Interventions

  • OtherGroup (c): control group patients will receive general anesthesia.

    control group patients will receive general anesthesia.

  • ProcedureGroup (SS): Sphenopalatine Ganglion Block with either Scalp Nerve Block

    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 1. Supraorbital Nerve Block 2. Supratrochlear nerve block 3. Zygomaticotemporal nerve block 4. Auriculotemporal nerve block

  • ProcedureGroup (SL): patients will receive Sphenopalatine Ganglion Block with local wound infiltration

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: the first time after recovery from anesthesia when visual analog scale more than or equal 3 at first 24 hours postoperative

Secondary outcomes

  1. 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.

    Time frame: at 0 minutes and 1,2,4,6,8 ,12,18,24 hours postoperative.

  2. 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

    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

  3. Total Dose of rescue analgesia (nalbuphine) mg

    Total Dose of rescue analgesia (nalbuphine) by mg used in the first 24 hours will be recorded.

    Time frame: in the first 24 hours will be recorded.

07

Study locations

No study locations are listed for this record.

08

References and documents

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 4048757 ↗
  • Pini 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 25169006 ↗
  • Gitman 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 31461049 ↗
  • Ramsay 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 4835444 ↗
  • Nguyen 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 11682413 ↗
  • Pinosky 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 8942596 ↗
  • Piagkou 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 21956040 ↗
  • Jensen 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 3785962 ↗
  • 6. 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 31153358 ↗
  • Mantovani 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 38262005 ↗
  • 2. 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 documents

  • Study protocol · Oct 16, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: planned after the completion of the study publication

Access criteria: principal investigator

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Mar 2027, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2026
First posted
Oct 21, 2026
StartEst.
Oct 30, 2026
Primary completionEst.
Mar 24, 2027
CompletionEst.
Apr 24, 2027
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07886034
Lead sponsor
Zagazig University
Responsible party
Amany Deedamony Said Ahmed Shehata (lecture, Zagazig University) — Principal investigator
First posted
Oct 21, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Mar 24, 2027 (estimated)
Completion
Apr 24, 2027 (estimated)
Last update
Oct 21, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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