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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
EU CTIS ID: 2024-512112-22-01
What this study is testing
The primary objective will be the hemodynamic change observed at the time of placement of the spiked headrest (Mayfield's headrest).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients undergoing craniotomy for supratentorial mass
- ASA 1-2
- All genders
- 18-85 years old
You likely can't join if
- BMI<18 or >35 or weight <50 kg
- Renal Insufficiency (under 45ml/min of GFR)
- Liver dysfunction (defined by presence of ascitis or coagulation dysfunction)
- Uncontrolled hypertension (more than 160mmHg systolic pressure) at home or requiring more than 2 anti-hypertensive treatments
- A hypersensitivity and/or a contraindication to one or more of the medications and/or its excipients used in the study Chronic pain (chronic medication and/or presence of a neurostimulator), fibromyalgia, psychiatric disorders, alcoholism and/or chronic use of strong opioids (considered chronic if taking a strong opioid on a daily basis for > 1 week) preoperatively
- A contraindication to a loco-regional anesthesia technique
See the full eligibility criteria
- Patients undergoing craniotomy for supratentorial mass
- ASA 1-2
- All genders
- 18-85 years old
- BMI<18 or >35 or weight <50 kg
- Renal Insufficiency (under 45ml/min of GFR)
- Liver dysfunction (defined by presence of ascitis or coagulation dysfunction)
- Uncontrolled hypertension (more than 160mmHg systolic pressure) at home or requiring more than 2 anti-hypertensive treatments
- A hypersensitivity and/or a contraindication to one or more of the medications and/or its excipients used in the study Chronic pain (chronic medication and/or presence of a neurostimulator), fibromyalgia, psychiatric disorders, alcoholism and/or chronic use of strong opioids (considered chronic if taking a strong opioid on a daily basis for > 1 week) preoperatively
- A contraindication to a loco-regional anesthesia technique
- Pregnancy, breastfeeding or unappropriate contraception use for fertile female subjects (b-HCG will be done for fertile female)
- Refusal of consent by the patient
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.