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Evaluation of the efficacy of Sphenopalatine Ganglion Block compared to Scalp Block in Supratentorial Intracranial Surgery : a Non-inferiority, Randomized, Controlled, Double-Blind Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512112-22-01
Enrollment
88
Registered
2024-09-06
Start date
2024-12-04
Completion date
Unknown
Last updated
2024-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing craniotomy for supratentorial mass

Brief summary

hemodynamic change observed at the time of placement of the spiked headrest (Mayfield's headrest).

Detailed description

Hemodynamic variation during skin incision, flap and dura mater incision, Analysis of intraoperative parameters (heart rate, blood pressure, Response and State Entropy (RE/SE), Surgical Plethysmographic Index (SPI) at the time of block, incision, craniectomy and dura mater incision., Absence of complications related to the block (AL toxicity, infection, etc.), Level of sleepiness in USPA (RASS score), Pain scores at the different time intervals shown in the table from the PCU to hospital discharge, Morphine use in the PACU and in the hospital ward, Length of hospital stay, Evaluation of QoR15 on D-1, D+1, D+3, D+7, Evaluation of patient satisfaction via the EVAN-G score, Presence of PONV, constipation, pruritus during hospitalization

Interventions

DRUGChlorure de sodium 0
DRUGPropofol B. Braun 2 % (20 mg/ml)
DRUGsolution injectable/ pour perfusion
DRUGsolution injectable
DRUGUltiva 5 mg poudre pour solution à diluer pour solution injectable/pour perfusion
DRUGParacetamol Fresenius Kabi 10 mg/ml solution pour perfusion
DRUGEtoricoxib AB 60 mg filmomhulde tabletten
DRUGNimbex 2 mg/ml

Sponsors

Centre hospitalier universitaire de Liege
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
hemodynamic change observed at the time of placement of the spiked headrest (Mayfield's headrest).

Secondary

MeasureTime frame
Hemodynamic variation during skin incision, flap and dura mater incision, Analysis of intraoperative parameters (heart rate, blood pressure, Response and State Entropy (RE/SE), Surgical Plethysmographic Index (SPI) at the time of block, incision, craniectomy and dura mater incision., Absence of complications related to the block (AL toxicity, infection, etc.), Level of sleepiness in USPA (RASS score), Pain scores at the different time intervals shown in the table from the PCU to hospital discharge, Morphine use in the PACU and in the hospital ward, Length of hospital stay, Evaluation of QoR15 on D-1, D+1, D+3, D+7, Evaluation of patient satisfaction via the EVAN-G score, Presence of PONV, constipation, pruritus during hospitalization

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026