HemorrhoidsPUSHESNCT07350460
PUSHES (Pudendal Block Versus Sacral ESP Hemorrhoidectomy Study)
A study testing Pudendal block AL and Sacral ESP block AL in people with Hemorrhoids and Hemorrhoids Third Degree, run by Andrea Saporito at 1 site in Switzerland.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemorrhoids, Hemorrhoids Third Degree
- What is being tested?
- Pudendal block AL and Sacral ESP block AL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Jan 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Ospedale Regionale Bellinzona e Valli (ORBV) CH-6500 Bellinzona Switzerland
Bellinzona, 6500
Roberto Dossi, Dr. Med., 0041 (0) 91 811 ext. 9341, Roberto.Dossi@eoc.ch
Alessandra Lauretta, Dr. Med., 0041 (0)91 811 ext. 8182, Alessandra.Lauretta@eoc.ch
About this study
Official title: A Randomized, Double-Blind Trial Comparing Pudendal Block Versus Sacral ESP for Ambulatory Hemorrhoidectomy
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?
Read the detailed description
Hemorrhoidectomy remains one of the most common anorectal procedures performed worldwide, yet it is frequently associated with significant postoperative pain that can impair recovery, delay discharge, and increase unplanned healthcare utilization. Effective analgesia is therefore a central component of perioperative care in this population.
Traditionally, the pudendal nerve block has been used to provide postoperative analgesia after hemorrhoidectomy. While effective, this technique requires precise anatomical identification, can be technically challenging, and is associated with potential risks such as vascular puncture or local anesthetic systemic toxicity. More recently, the sacral erector spinae plane (ESP) block has been described as a simpler, ultrasound-guided technique that may provide effective analgesia for procedures involving the perineal and anorectal region. Its safety profile and ease of performance could represent an attractive alternative to the pudendal nerve block, especially in the ambulatory setting.
The PUSHES trial is designed as a randomized, controlled, double-blind study to directly compare the efficacy of sacral ESP block versus pudendal nerve block for pain control after ambulatory hemorrhoidectomy. A total of 64 adult patients undergoing elective hemorrhoidectomy under standardized spinal anesthesia will be enrolled. Following spinal anesthesia, participants will be randomized to receive either a sacral ESP block with ropivacaine and a sham pudendal block with saline, or a pudendal block with ropivacaine and a sham sacral ESP block with saline. This double-dummy design ensures blinding of patients, anesthesiologists, and outcome assessors.
The primary endpoint is pain intensity at 4 hours postoperatively, measured using a 10-point Visual Analog Scale (VAS). Secondary endpoints include pain scores at 12 and 24 hours, time to first rescue analgesia, opioid consumption, functional recovery milestones (mobilization, ability to void, return to baseline activity), and block-related or systemic adverse events.
By systematically comparing these two techniques, this trial aims to identify whether the sacral ESP block can provide equivalent or superior analgesia to the pudendal nerve block while offering a simpler, safer alternative for routine clinical practice.
- Conditions
- Hemorrhoids, Hemorrhoids Third Degree
- Being tested
- Pudendal block AL, Sacral ESP block AL, Sacral ESP block Sham, Pudendal block Sham
- Keywords
- Hemorrhoids, Hemorrhoidectomy, Postoperative Pain, Pain Measurement
- Medical subject headings
- Hemorrhoids, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pudendal block ALProcedure or surgery
Patients in the control group will receive an ultrasound-guided bilateral pudendal nerve block with 20 mL of 0.75% ropivacaine
Sacral ESP block ALProcedure or surgery
Patients in the intervention group will receive an ultrasound-guided sacral ESP block with 20 mL of 0.75% ropivacaine
Sacral ESP block ShamProcedure or surgery
Patients in the control group will receive a sacral ESP block with 20 mL of normal saline.
Pudendal block ShamProcedure or surgery
Patients will receive a bilateral pudendal nerve block with 20 mL of normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Pudendal block | Active comparator | Patients 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 Receives: Procedure: Pudendal block AL; Procedure: Sacral ESP block Sham |
| Sacral ESP block | Experimental | Patients 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. Receives: Procedure: Sacral ESP block AL; Procedure: Pudendal block Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity, assessed using the Visual Analogue Scale (VAS) at 4 hours following surgery in day 0
Measured: Day 0
Secondary outcomes (3)
VAS (Visual Analogue Score) pain scores at 12 hours and 24 hours postoperatively
Measured: Day 0 and day 1
Time to first request for rescue analgesia in 24 hours
Measured: Day 0 and day 1
Total amount of rescue analgesia in 24 hours
Measured: Day 0 and day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start5 Jan 2026
- Primary completion29 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrea Saporito
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrea Saporito, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Andrea Saporito, Prof. Dr. Med., Study chair, Department of Anesthesiology, Ospedale San Giovanni, Ente Ospedaliero Cantonale, Bellinzona, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350460
- Sponsor's protocol ID
- PUSHES trial
- Acronym
- PUSHES
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33585088
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Trial Comparing Pudendal Block Versus Sacral ESP for Ambulatory Hemorrhoidectomy
- ClinicalTrials.gov ID
- NCT07350460
- Acronym / sponsor ID
- PUSHES / PUSHES trial
- Conditions
- Hemorrhoids, Hemorrhoids Third Degree
- Keywords
- Hemorrhoids, Hemorrhoidectomy, Postoperative Pain, Pain Measurement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Andrea SaporitoUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 29 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Hemorrhoidectomy remains one of the most common anorectal procedures performed worldwide, yet it is frequently associated with significant postoperative pain that can impair recovery, delay discharge, and increase unplanned healthcare utilization. Effective analgesia is therefore a central component of perioperative care in this population.
Traditionally, the pudendal nerve block has been used to provide postoperative analgesia after hemorrhoidectomy. While effective, this technique requires precise anatomical identification, can be technically challenging, and is associated with potential risks such as vascular puncture or local anesthetic systemic toxicity. More recently, the sacral erector spinae plane (ESP) block has been described as a simpler, ultrasound-guided technique that may provide effective analgesia for procedures involving the perineal and anorectal region. Its safety profile and ease of performance could represent an attractive alternative to the pudendal nerve block, especially in the ambulatory setting.
The PUSHES trial is designed as a randomized, controlled, double-blind study to directly compare the efficacy of sacral ESP block versus pudendal nerve block for pain control after ambulatory hemorrhoidectomy. A total of 64 adult patients undergoing elective hemorrhoidectomy under standardized spinal anesthesia will be enrolled. Following spinal anesthesia, participants will be randomized to receive either a sacral ESP block with ropivacaine and a sham pudendal block with saline, or a pudendal block with ropivacaine and a sham sacral ESP block with saline. This double-dummy design ensures blinding of patients, anesthesiologists, and outcome assessors.
The primary endpoint is pain intensity at 4 hours postoperatively, measured using a 10-point Visual Analog Scale (VAS). Secondary endpoints include pain scores at 12 and 24 hours, time to first rescue analgesia, opioid consumption, functional recovery milestones (mobilization, ability to void, return to baseline activity), and block-related or systemic adverse events.
By systematically comparing these two techniques, this trial aims to identify whether the sacral ESP block can provide equivalent or superior analgesia to the pudendal nerve block while offering a simpler, safer alternative for routine clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pudendal block | Active comparator | Procedure: Pudendal block AL, Procedure: Sacral ESP block ShamPatients 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 | Experimental | Procedure: Sacral ESP block AL, Procedure: Pudendal block ShamPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pudendal block ALPatients in the control group will receive an ultrasound-guided bilateral pudendal nerve block with 20 mL of 0.75% ropivacaine | Procedure or surgery | Pudendal block |
| Sacral ESP block ALPatients in the intervention group will receive an ultrasound-guided sacral ESP block with 20 mL of 0.75% ropivacaine | Procedure or surgery | Sacral ESP block |
| Sacral ESP block ShamPatients in the control group will receive a sacral ESP block with 20 mL of normal saline. | Procedure or surgery | Pudendal block |
| Pudendal block ShamPatients will receive a bilateral pudendal nerve block with 20 mL of normal saline. | Procedure or surgery | Sacral ESP block |
Primary outcome
Postoperative pain intensity, assessed using the Visual Analogue Scale (VAS) at 4 hours following surgery in day 0
Time frame: Day 0
3 secondary outcomes
VAS (Visual Analogue Score) pain scores at 12 hours and 24 hours postoperatively
Time frame: Day 0 and day 1
Time to first request for rescue analgesia in 24 hours
Time frame: Day 0 and day 1
Total amount of rescue analgesia in 24 hours
Time frame: Day 0 and day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Results publication: PubMed 33585088Kaya 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Saporito, Prof. Dr. Med. study chair
Department of Anesthesiology, Ospedale San Giovanni, Ente Ospedaliero Cantonale, Bellinzona, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pudendal block AL and Sacral ESP block AL in people with Hemorrhoids and Hemorrhoids Third Degree, run by Andrea Saporito at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Dossi, Dr. Med. (0041 (0)91 811 ext. 9341, Roberto.Dossi@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity, assessed using the Visual Analogue Scale (VAS) at 4 hours following surgery in day 0 (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07350460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.