Table of Contents
- Trial overview
- Who is being studied
- What the trial measures
- Trial design and phase
- Trial status and size
- Important patient terms
Trial overview
The trial with NCT ID 2024-520132-15-00 is an interventional study that is authorised and plans to include 240 participants.[1] 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.[1]
Who is being studied
The target population is patients undergoing vitrectomy and/or cataract surgery.[1] These are eye surgery patients who are having retrobulbar anaesthesia, which is a numbing procedure used for the operation.[1]
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.[1] The source data does not give more detail about who can or cannot join beyond the surgery type.[1]
What the trial measures
The main endpoint is the NRS-P score 30 seconds after the retrobulbar block.[1] 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.[1]
The brief summary also says the study aims to investigate perioperative pain, and the title mentions perioperative anxiety and pain.[1] This means the researchers are interested in how patients feel around the time of surgery, especially pain and nervousness.[1]
Trial design and phase
This is an interventional study, which means the researchers are giving or comparing treatments as part of the study.[1] The phase is listed as Low Intervention, meaning the trial involves only limited extra intervention beyond usual care.[1]
The source data does not provide a classic drug development phase such as Phase 1, Phase 2, or Phase 3.[1] Instead, it uses the Low Intervention label, which is the phase-like category reported for this study.[1]
Trial status and size
The study status is Authorised, so it has been approved to proceed.[1] The planned enrollment is 240 participants, which gives an idea of the study size.[1]
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.[1] The data provided does not include final results, so the article can only describe what the trial is designed to study.[1]
Important patient terms
Vitrectomy is an eye operation, and cataract surgery is surgery to treat a cloudy lens in the eye.[1] Retrobulbar anaesthesia is a way to numb the eye area for surgery.[1]
Perioperative means the time around surgery, including before and after the operation.[1] Anxiety means worry or nervousness, and pain is the unpleasant feeling the study is trying to measure.[1]
