Pudendal nerve block versus sacral erector spinae (ESP) block for pain after hemorrhoidectomy

A Randomized, Double-Blind Trial Comparing Pudendal Block Versus Sacral ESP for Ambulatory Hemorrhoidectomy

This will test whether the sacral erector spinae (ESP) block gives equal or better pain relief than the pudendal nerve block for adults having elective hemorrhoid surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Ente Ospedaliero Cantonale, Bellinzona (Academic / other)
• Locations: 1 site (Bellinzona)
• Trial ID: NCT07350460 on ClinicalTrials.gov

What this trial studies

Hemorrhoidectomy commonly causes significant postoperative pain that can slow recovery and increase unplanned healthcare use. The PUSHES trial randomizes 64 adults undergoing elective excisional hemorrhoidectomy under standardized spinal anesthesia to receive either an ultrasound-guided sacral ESP block or a pudendal nerve block, with sham procedures to maintain blinding. Outcomes include postoperative pain scores, opioid consumption, and recovery metrics such as time to discharge. The sacral ESP block is a newer, potentially simpler ultrasound-guided technique that may offer easier performance and a favorable safety profile compared with the pudendal block.

Who should consider this trial

Good fit: Adults aged 18 or older scheduled for elective excisional hemorrhoidectomy who can provide informed consent, are ASA I–III, and meet the study's weight and BMI limits (not under 50 kg and BMI ≤40) are ideal candidates.

Not a fit: Patients who are pregnant, weigh under 50 kg, have BMI >40, have allergies to local anesthetics, significant coagulation disorders or anticoagulation, infection at the puncture site, relevant neurological disorders, severe psychiatric illness, or language barriers will be excluded and are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the sacral ESP block could provide equal or better pain relief while being easier and safer to perform, potentially speeding recovery and reducing unplanned visits after hemorrhoidectomy.

How similar studies have performed: The pudendal block is an established option for postoperative analgesia, while sacral ESP blocks have encouraging case reports and small series but lack robust randomized trial evidence.

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

Where this trial is running

Bellinzona

• Ospedale Regionale Bellinzona e Valli (ORBV) CH-6500 Bellinzona Switzerland — Bellinzona, Switzerland (Recruiting)

Study contacts

• Study coordinator: Roberto Dossi, Dr. Med.

Conditions Hemorrhoids; Hemorrhoids Third Degree; Hemorrhoidectomy; Postoperative Pain; Pain Measurement