PUSHES (Pudendal Block Versus Sacral ESP Hemorrhoidectomy Study)
PUSHES
A Randomized, Double-Blind Trial Comparing Pudendal Block Versus Sacral ESP for Ambulatory Hemorrhoidectomy
1 other identifier
interventional
64
1 country
1
Brief Summary
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2025
CompletedStudy Start
First participant enrolled
January 5, 2026
CompletedFirst Posted
Study publicly available on registry
January 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
March 18, 2026
December 1, 2025
1.7 years
December 30, 2025
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative pain intensity, assessed using the Visual Analogue Scale (VAS) at 4 hours following surgery in day 0
Day 0
Secondary Outcomes (3)
VAS (Visual Analogue Score) pain scores at 12 hours and 24 hours postoperatively
Day 0 and day 1
Time to first request for rescue analgesia in 24 hours
Day 0 and day 1
Total amount of rescue analgesia in 24 hours
Day 0 and day 1
Study Arms (2)
Pudendal block
ACTIVE COMPARATORPatients in the control group will receive an ultrasound-guided bilateral pudendal nerve block with 20 mL of 0.75% ropivacaine and a sacral ESP block with 20 mL of normal saline. Blinding is ensured by the double block procedure
Sacral ESP block
EXPERIMENTALPatients in the intervention group will receive an ultrasound-guided sacral ESP block with 20 mL of 0.75% ropivacaine and a bilateral pudendal nerve block with 20 mL of normal saline.
Interventions
Patients in the control group will receive an ultrasound-guided bilateral pudendal nerve block with 20 mL of 0.75% ropivacaine
Patients in the intervention group will receive an ultrasound-guided sacral ESP block with 20 mL of 0.75% ropivacaine
Patients in the control group will receive a sacral ESP block with 20 mL of normal saline.
Patients will receive a bilateral pudendal nerve block with 20 mL of normal saline.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Andrea Saporitolead
Study Sites (1)
Ospedale Regionale Bellinzona e Valli (ORBV) CH-6500 Bellinzona Switzerland
Bellinzona, 6500, Switzerland
Related Publications (1)
Kaya C, Dost B, Tulgar S. Sacral Erector Spinae Plane Block Provides Surgical Anesthesia in Ambulatory Anorectal Surgery: Two Case Reports. Cureus. 2021 Jan 9;13(1):e12598. doi: 10.7759/cureus.12598.
PMID: 33585088RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Andrea Saporito, Prof. Dr. Med.
Department of Anesthesiology, Ospedale San Giovanni, Ente Ospedaliero Cantonale, Bellinzona, Switzerland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. Med.
Study Record Dates
First Submitted
December 30, 2025
First Posted
January 20, 2026
Study Start
January 5, 2026
Primary Completion (Estimated)
September 29, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
March 18, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
Individual participant data (IPD) will be shared upon reasonable request from qualified investigators by contacting the Principal Investigator via email. Due to the double-blind design of the study, raw data will not be shared before study completion, unblinding, and final statistical analyses. Following these steps, de-identified individual-level data may be made available to support requests aimed at verifying or challenging the reported findings, subject to appropriate scientific justification and compliance with applicable data protection regulations.