Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07350460
Eligibility Criteria:
Inclusion Criteria:
* Adults (≥18 years old) scheduled for elective excisional hemorrhoidectomy;
* Ability to understand the nature of the study and provide written informed consent;
* American Society of Anesthesiologists (ASA) physical status I-III;
* Ability to comply with study procedures and postoperative evaluations.
Exclusion Criteria:
* Pregnancy;
* Body weight under 50 kg due to the potential risk of local anaesthetic systemic toxicity (LAST);
* BMI \> 40; Known allergy or contraindication to local anaesthetics (e.g., ropivacaine, prilocaine);
* Severe coagulation disorders or current anticoagulant therapy contraindicating spinal or peripheral deep nerve blocks (like pudendal block, because Sacral ESP is considered a superficial block);
* Infection at the puncture site;
* Neurological disorders affecting the sacral or pudendal nerve pathways;
* Severe psychiatric conditions impairing study participation;
* Language barriers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07350460
Study Brief:
Protocol Section:
NCT07350460