In short
Clinical trials are investigating VALERIAN ROOT TE WITH ETHANOL/ETHANOL WATER in patients having eye surgery. These studies look at perioperative anxiety and pain, and compare it with other treatments during retrobulbar anaesthesia.
Key points
- Clinical trials investigating VALERIAN ROOT TE WITH ETHANOL/ETHANOL WATER are focused on patients having vitrectomy and/or cataract surgery. The study is looking at perioperative anxiety and pain, especially around retrobulbar anaesthesia. It is an interventional, low-intervention trial with 240 planned participants. The main measurement is the NRS-P pain score 30 seconds after the retrobulbar block. The trial is currently authorised.
Trial overview
The trial with NCT ID 2024-520132-15-00 is an interventional study that is authorised and plans to include 240 participants. It is studying patients undergoing vitrectomy and/or cataract surgery, and the brief summary says the study aims to investigate the effect of music on perioperative pain and the effect of herbal medicine on perioperative pain.
Who is being studied
The target population is patients undergoing vitrectomy and/or cataract surgery. These are eye surgery patients who are having retrobulbar anaesthesia, which is a numbing procedure used for the operation.
The trial compares oral interventions listed as Nervenruh forte - Dragees and Bromazepam Genericon 3 mg Filmtabletten, with the herbal medicine focus stated in the brief summary. The source data does not give more detail about who can or cannot join beyond the surgery type.
What the trial measures
The main endpoint is the NRS-P score 30 seconds after the retrobulbar block. An endpoint is the main result a study wants to measure, and in this trial it is used to check pain soon after the anaesthetic block.
The brief summary also says the study aims to investigate perioperative pain, and the title mentions perioperative anxiety and pain. This means the researchers are interested in how patients feel around the time of surgery, especially pain and nervousness.
Trial design and phase
This is an interventional study, which means the researchers are giving or comparing treatments as part of the study. The phase is listed as Low Intervention, meaning the trial involves only limited extra intervention beyond usual care.
The source data does not provide a classic drug development phase such as Phase 1, Phase 2, or Phase 3. Instead, it uses the Low Intervention label, which is the phase-like category reported for this study.
Trial status and size
The study status is Authorised, so it has been approved to proceed. The planned enrollment is 240 participants, which gives an idea of the study size.
Because the trial is focused on eye surgery patients, the results may help show whether the study approach changes pain after retrobulbar anaesthesia in this setting. The data provided does not include final results, so the article can only describe what the trial is designed to study.
Important patient terms
Vitrectomy is an eye operation, and cataract surgery is surgery to treat a cloudy lens in the eye. Retrobulbar anaesthesia is a way to numb the eye area for surgery.
Perioperative means the time around surgery, including before and after the operation. Anxiety means worry or nervousness, and pain is the unpleasant feeling the study is trying to measure.