Health TrialsbyHealthPanel

PUSHES (Pudendal Block Versus Sacral ESP Hemorrhoidectomy Study)

ConditionsHemorrhoidsHemorrhoids Third Degree
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Pudendal block AL

    Procedure/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 AL

    Procedure/Surgery

    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/Surgery

    Patients in the control group will receive a sacral ESP block with 20 mL of normal saline.

  • Pudendal block Sham

    Procedure/Surgery

    Patients will receive a bilateral pudendal nerve block with 20 mL of normal saline.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Pudendal blockActive comparator 2 interventions
Group B: Sacral ESP blockExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Postoperative pain intensity, assessed using the Visual Analogue Scale (VAS) at 4 hours following surgery in day 0

Time frame
Day 0

Secondary outcomes

1

VAS (Visual Analogue Score) pain scores at 12 hours and 24 hours postoperatively

Time frame
Day 0 and day 1
2

Time to first request for rescue analgesia in 24 hours

Time frame
Day 0 and day 1
3

Total amount of rescue analgesia in 24 hours

Time frame
Day 0 and day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Andrea Saporito

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Sponsor institution

Source ClinicalTrials.gov
Apply now