In short
This article provides information about ongoing clinical trials for patients undergoing craniotomy, a surgical procedure where part of the skull is removed to access the brain. Currently, there is 1 clinical trial actively recruiting participants. This trial is investigating different pain management techniques during surgery for patients with growths in the upper part of the brain.
Clinical trial locations
Study on the Effectiveness of Sphenopalatine Ganglion Block vs. Scalp Block in Patients Undergoing Craniotomy for Supratentorial Mass Using Levobupivacaine and Drug Combination
This clinical trial is taking place in Belgium and focuses on comparing two different pain management techniques during brain surgery. The study is designed for patients who need a craniotomy to treat a supratentorial mass, which is an abnormal growth located in the upper part of the brain.
Who can participate:
- Adults between 18 and 85 years old
- Patients scheduled for craniotomy surgery for a supratentorial mass
- Patients classified as ASA 1-2, meaning they are either healthy or have mild health issues
- All genders are eligible
Who cannot participate:
- Patients not undergoing craniotomy for a supratentorial mass
- Patients outside the specified age range
- Patients who belong to vulnerable populations requiring special protection
- Patients who do not meet the clinical trial group criteria
What the trial involves:
The main goal of this study is to compare the effectiveness of two pain management methods: the Sphenopalatine Ganglion Block and the Scalp Block. Both techniques involve numbing specific areas to help control pain during and after surgery.
The Sphenopalatine Ganglion Block works by applying a local anesthetic to a specific cluster of nerves located behind the nose. This technique blocks pain signals and can help reduce discomfort during the surgical procedure. The Scalp Block, on the other hand, involves injecting a local anesthetic directly into the scalp to numb the area where the surgery takes place.
During the study, researchers will monitor how these pain management techniques affect the body's responses, such as heart rate and blood pressure, particularly when a special headrest is used during surgery. The trial will also measure the level of pain relief, the need for additional pain medications like morphine, and any side effects that may occur.
Medications used in the trial:
Participants will receive several medications throughout their surgical journey, including morphine hydrochloride for pain relief, methylprednisolone to reduce inflammation, propofol for sedation, lidocaine hydrochloride for local anesthesia, remifentanil for pain management, paracetamol and etoricoxib for post-surgery pain relief, cisatracurium besilate for muscle relaxation, and levobupivacaine as part of the nerve block procedure. Sodium chloride is used as a solvent for other medications.
Study design:
This is a double-blind study, which means that neither the participants nor the researchers will know which pain management method is being used during the surgery. This approach helps ensure that the results are objective and unbiased. Throughout the hospital stay, participants will be monitored for their level of comfort, satisfaction, and any side effects they may experience.
The trial is expected to run until 2026, with recruitment having started in 2024.
Summary
Currently, there is one ongoing clinical trial available for patients undergoing craniotomy surgery. This trial is being conducted in Belgium and focuses specifically on improving pain management techniques during surgery for patients with supratentorial masses. The study compares two different nerve block methods and uses a combination of medications, including levobupivacaine, to optimize patient comfort and reduce the body's stress responses during the procedure.
Patients interested in participating should discuss eligibility with their healthcare provider, as the trial has specific requirements regarding age, health status, and the type of surgery being performed. The double-blind design of the study ensures that results will provide reliable information about which pain management technique may be more effective for future patients undergoing similar procedures.
