Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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?
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pudendal block AL | Procedure | Patients in the control group will receive an ultrasound-guided bilateral pudendal nerve block with 20 mL of 0.75% ropivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain intensity, assessed using the Visual Analogue Scale (VAS) at 4 hours following surgery in day 0 | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Dossi, Dr. Med. | Contact | 0041 (0)91 811 | 9341 | Roberto.Dossi@eoc.ch |
| Alessandra Lauretta, Dr. Med. | Contact | 0041 (0)91 811 | 8182 | Alessandra.Lauretta@eoc.ch |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Saporito, Prof. Dr. Med. | Department of Anesthesiology, Ospedale San Giovanni, Ente Ospedaliero Cantonale, Bellinzona, Switzerland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Regionale Bellinzona e Valli (ORBV) CH-6500 Bellinzona Switzerland | Recruiting | Bellinzona | 6500 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33585088 | Result | 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. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sacral ESP block AL | Procedure | Patients in the intervention group will receive an ultrasound-guided sacral ESP block with 20 mL of 0.75% ropivacaine |
|
| Sacral ESP block Sham | Procedure | Patients in the control group will receive a sacral ESP block with 20 mL of normal saline. |
|
| Pudendal block Sham | Procedure | Patients will receive a bilateral pudendal nerve block with 20 mL of normal saline. |
|
| Total amount of rescue analgesia in 24 hours |
| Day 0 and day 1 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |