PUSHES (Pudendal Block Versus Sacral ESP Hemorrhoidectomy Study)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAndrea Saporito
About this trial
The goal of this clinical trial is to learn if the sacral erector spinae plane block can provide equal or better pain control than the pudendal nerve block in adults undergoing hemorrhoid surgery. The main question is: Which block offers more effective analgesia and faster recovery?
Eligibility criteria
Qualifiers
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.
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Pudendal block AL
- Sacral ESP block AL
- Sacral ESP block Sham
- Pudendal block Sham
Treatment groups
64 Participants
are divided into 2 treatment groupsSponsors and collaborators
Andrea Saporito
Lead sponsor
Ente Ospedaliero Cantonale, Bellinzona
Sponsor institution
Source ClinicalTrials.gov