HemorrhoidsBACHNCT07015775
Evaluation of the Analgesic Efficacy of an Ultrasound-guided Transperineal Pudendal Block in Outpatient Hemorrhoidal Surgery
A study testing Neurostimulation and Ultrasound in people with Hemorrhoids, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
In a population of patients undergoing hemorrhoidal surgery under general anesthesia and divided into two equal groups based on the method used for intraoperative pudendal nerve block and its branches in the ischioanal fossa: Group 1: Pudendal block guided by neurostimulation Group 2: Pudendal block guided by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Neurostimulation and Ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2025to 8 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female patient
- Patient who has signed informed consent to participate in the study
- Patient scheduled for outpatient hemorrhoidal surgery under general anesthesia
Who cannot join
- History of hemorrhoidal surgery
- Allergy or contraindication to any of the medications used in the study
- Patient undergoing surgery under spinal anesthesia
- History of chronic pain requiring opioid use, unrelated to hemorrhoids
- Mental impairment or any other condition that could hinder understanding or strict adherence to the protocol
- Patient not affiliated with the French national health insurance system
Show all 9Show fewer
- Patient under legal protection (e.g., guardianship, trusteeship, or court protection)
- Pregnant woman or woman at risk of being pregnant (i.e., of childbearing age without effective contraception and without an HCG test)
- Patient already enrolled in another therapeutic clinical trial or within the exclusion period of another clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Privé Claude Galien
Quincy-sous-Sénart, 91480
Thomas GIRAL, MD, 01 69 39 15 53 ext. 33, thomasgiral@gmail.com
About this study
In a population of patients undergoing hemorrhoidal surgery under general anesthesia and divided into two equal groups based on the method used for intraoperative pudendal nerve block and its branches in the ischioanal fossa:
Group 1: Pudendal block guided by neurostimulation Group 2: Pudendal block guided by ultrasound
The primary objective of this study is to compare the maximum immediate postoperative pain score between the two groups (pain reported by the patients in the recovery room on a simple numeric scale before morphine titration).
Read the detailed description
This is a multicenter, prospective, randomized, double-blind study conducted on two parallel groups of patients undergoing hemorrhoidal surgery (pudendal block guided by neurostimulation versus pudendal block guided by ultrasound).
Study Duration The total study duration per patient is 7 days. The recruitment period is set at 12 months.
Justification of the Experimental Protocol The aim of this study is to compare two methods of performing a pudendal block. Patient allocation to either strategy will be determined by randomization. Bilateral pudendal nerve block and its branches in the ischioanal fossa will be performed after induction of general anesthesia.
To maintain double blinding, postoperative data will be collected by a physician other than the anesthesiologist performing the block, and by nursing staff under their supervision. None of these personnel will be informed of the patient's group allocation.
- Conditions
- Hemorrhoids
- Being tested
- Neurostimulation, Ultrasound
- Keywords
- hemorroidal surgery
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurostimulationProcedure or surgery
Procedure guided by neurostimulation
UltrasoundProcedure or surgery
Procedure guided by ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Pudendal block guided by neurostimulation | Active comparator | Neurostimulation involves using an electrical impulse to trigger a nerve signal and a specific motor response. A short-bevel, insulated 80 mm needle connected to a neurostimulator is used. The puncture point lies midway between the ischial tuberosity and the anus. Stimulation starts at 2.5 mA, 1 Hz, and the needle is advanced 4-5 cm until anal sphincter contraction occurs ("anal wink"). The needle is adjusted to maintain the response while reducing intensity to 0.5 mA. If lost, intensity is increased; if too intense at 0.3 mA, the needle is repositioned. After confirming no vascular puncture, 1 mL of Ropivacaine 3.5 mg/mL is injected to stop contraction, followed by slow injection of 15 mL total. The procedure is repeated on the other side. If no motor response occurs, a blind injection is performed after negative aspiration at 5 cm depth using the same landmarks. Receives: Procedure: Neurostimulation |
| Pudendal block guided by ultrasound | Experimental | A 6 MHz convex probe is placed in the frontal plane along the line between the ischial tuberosity and the anal margin to visualize the bony prominence. The pudendal artery and nearby nerves are identified using color Doppler. A 22-gauge, 80 mm echogenic needle is inserted out-of-plane in front of the probe, targeting the lateral ischioanal fossa just medial to the pudendal artery, if visible. The probe is adjusted to center the artery. Block confirmation is based on ultrasound visualization of local anesthetic spreading into the fatty tissue medial to the pudendal artery. The procedure is repeated on the other side. If the artery is not visible, the injection is performed after negative aspiration on the medial aspect of the ischial tuberosity, along the line to the anus, at a depth of 4-5 cm. Receives: Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain assessment in the Post-Anesthesia Care Unit (PACU)
The primary endpoint of the study is the maximum pain score in the Post-Anesthesia Care Unit (PACU) before morphine titration.
Postoperative pain in the recovery room will be recorded by the nursing staff using a simple numeric scale from 0 to 10 after questioning the patient, following standard departmental procedures. The maximum pain score before morphine titration constitutes the primary evaluation criterion.
Measured: Hour 2
Secondary outcomes (19)
Quantitative Opioid Consumption
Mean amount of morphine administered in each group
Measured: Hour 2
Qualitative Opioid Consumption
Percentage of patients in each group with zero morphine use
Measured: Hour 2
Postoperative recovery assessment
QOR-15 accurately assesses postoperative recovery across five key domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is rated from 0 (poor) to 10 (excellent), with a total score ranging from 0 (no recovery) to 150 (full recovery).
Measured: Day 1
Postoperative recovery assessment
QOR-15 accurately assesses postoperative recovery across five key domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is rated from 0 (poor) to 10 (excellent), with a total score ranging from 0 (no recovery) to 150 (full recovery).
Measured: Day 3
Postoperative recovery assessment
QOR-15 accurately assesses postoperative recovery across five key domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is rated from 0 (poor) to 10 (excellent), with a total score ranging from 0 (no recovery) to 150 (full recovery).
Measured: Day 7
Postoperative Pain assessment at rest
Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.
Measured: Day 1
Postoperative Pain assessment at rest
Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.
Measured: Day 3
Postoperative Pain assessment at rest
Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.
Measured: Day 7
Postoperative Pain assessment during walking
Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.
Measured: Day 1
Postoperative Pain assessment during walking
Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.
Measured: Day 3
Postoperative Pain assessment during walking
Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.
Measured: Day 7
Postoperative Pain assessment during First defecation
Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.
Measured: Day 7
Non-Opioid Postoperative Medication Use
Use of non-opioid analgesics and antiemetics during hospitalization. Use of analgesics as reported by the patients.
Measured: Day 1
Pudendal block procedure duration
Duration of pudendal block procedure
Measured: Hour 2
Sensory block duration
Duration of sensory block
Measured: Day 7
Length of stay in the PACU
Length of stay in the PACU
Measured: Day 1
Total hospital stay duration
Total hospital stay duration
Measured: Day 1
Time to first defecation
Time to first defecation
Measured: Day 7
Tolerance
Procedure tolerance will be assessed by recording all adverse events (serious or non-serious) with a potential causal link to analgesia
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Aug 2025 (estimated)
- Primary completion8 Aug 2026 (estimated)
- Study completion8 Aug 2026 (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.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Model description
- multicenter, prospective, randomized, double-blind study conducted on two parallel groups of patients undergoing hemorrhoidal surgery (pudendal block guided by neurostimulation versus pudendal block guided by ultrasound).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas GIRAL, MD, Principal investigator, Hôpital privé Claude Galien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015775
- Sponsor's protocol ID
- 2025-A00534-45
- Acronym
- BACH
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Giral T, Maupain O, Elmaleh Y, Huynh D, Ciceron F, Yao K, Devidas P, El Metni A, Kutter J. Ultrasound-guided versus neurostimulation-guided bilateral transperineal pudendal nerve block for analgesia in outpatient haemorrhoid surgery: protocol for a multicentre, randomised, double-blind, non-inferiority trial. BJA Open. 2025 Dec 9;16:100512. doi: 10.1016/j.bjao.2025.100512. eCollection 2025 Dec.
PubMed 41476689
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Efficacy of an Ultrasound-guided Transperineal Pudendal Block in Outpatient Hemorrhoidal Surgery
- ClinicalTrials.gov ID
- NCT07015775
- Acronym / sponsor ID
- BACH / 2025-A00534-45
- Conditions
- Hemorrhoids
- Keywords
- hemorroidal surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 8 Aug 2026 (estimated)
- Study completion
- 8 Aug 2026 (estimated)
- First posted
- 11 Jun 2025 (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.
In a population of patients undergoing hemorrhoidal surgery under general anesthesia and divided into two equal groups based on the method used for intraoperative pudendal nerve block and its branches in the ischioanal fossa:
Group 1: Pudendal block guided by neurostimulation Group 2: Pudendal block guided by ultrasound
The primary objective of this study is to compare the maximum immediate postoperative pain score between the two groups (pain reported by the patients in the recovery room on a simple numeric scale before morphine titration).
Detailed description
This is a multicenter, prospective, randomized, double-blind study conducted on two parallel groups of patients undergoing hemorrhoidal surgery (pudendal block guided by neurostimulation versus pudendal block guided by ultrasound).
Study Duration The total study duration per patient is 7 days. The recruitment period is set at 12 months.
Justification of the Experimental Protocol The aim of this study is to compare two methods of performing a pudendal block. Patient allocation to either strategy will be determined by randomization. Bilateral pudendal nerve block and its branches in the ischioanal fossa will be performed after induction of general anesthesia.
To maintain double blinding, postoperative data will be collected by a physician other than the anesthesiologist performing the block, and by nursing staff under their supervision. None of these personnel will be informed of the patient's group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- multicenter, prospective, randomized, double-blind study conducted on two parallel groups of patients undergoing hemorrhoidal surgery (pudendal block guided by neurostimulation versus pudendal block guided by ultrasound).
| Arm | Type | Receives |
|---|---|---|
| Pudendal block guided by neurostimulation | Active comparator | Procedure: NeurostimulationNeurostimulation involves using an electrical impulse to trigger a nerve signal and a specific motor response. A short-bevel, insulated 80 mm needle connected to a neurostimulator is used. The puncture point lies midway between the ischial tuberosity and the anus. Stimulation starts at 2.5 mA, 1 Hz, and the needle is advanced 4-5 cm until anal sphincter contraction occurs ("anal wink"). The needle is adjusted to maintain the response while reducing intensity to 0.5 mA. If lost, intensity is increased; if too intense at 0.3 mA, the needle is repositioned. After confirming no vascular puncture, 1 mL of Ropivacaine 3.5 mg/mL is injected to stop contraction, followed by slow injection of 15 mL total. The procedure is repeated on the other side. If no motor response occurs, a blind injection is performed after negative aspiration at 5 cm depth using the same landmarks. |
| Pudendal block guided by ultrasound | Experimental | Procedure: UltrasoundA 6 MHz convex probe is placed in the frontal plane along the line between the ischial tuberosity and the anal margin to visualize the bony prominence. The pudendal artery and nearby nerves are identified using color Doppler. A 22-gauge, 80 mm echogenic needle is inserted out-of-plane in front of the probe, targeting the lateral ischioanal fossa just medial to the pudendal artery, if visible. The probe is adjusted to center the artery. Block confirmation is based on ultrasound visualization of local anesthetic spreading into the fatty tissue medial to the pudendal artery. The procedure is repeated on the other side. If the artery is not visible, the injection is performed after negative aspiration on the medial aspect of the ischial tuberosity, along the line to the anus, at a depth of 4-5 cm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male or female patient
- Patient who has signed informed consent to participate in the study
- Patient scheduled for outpatient hemorrhoidal surgery under general anesthesia
Key exclusion criteria (9 listed)
- History of hemorrhoidal surgery
- Allergy or contraindication to any of the medications used in the study
- Patient undergoing surgery under spinal anesthesia
- History of chronic pain requiring opioid use, unrelated to hemorrhoids
- Mental impairment or any other condition that could hinder understanding or strict adherence to the protocol
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 |
|---|---|---|
| NeurostimulationProcedure guided by neurostimulation | Procedure or surgery | Pudendal block guided by neurostimulation |
| UltrasoundProcedure guided by ultrasound | Procedure or surgery | Pudendal block guided by ultrasound |
Primary outcome
Postoperative Pain assessment in the Post-Anesthesia Care Unit (PACU)
Time frame: Hour 2
The primary endpoint of the study is the maximum pain score in the Post-Anesthesia Care Unit (PACU) before morphine titration. Postoperative pain in the recovery room will be recorded by the nursing staff using a simple numeric scale from 0 to 10 after questioning the patient, following standard departmental procedures. The maximum pain score before morphine titration constitutes the primary evaluation criterion.
19 secondary outcomes
Quantitative Opioid Consumption
Time frame: Hour 2
Qualitative Opioid Consumption
Time frame: Hour 2
Postoperative recovery assessment
Time frame: Day 1
Postoperative recovery assessment
Time frame: Day 3
Postoperative recovery assessment
Time frame: Day 7
Postoperative Pain assessment at rest
Time frame: Day 1
Postoperative Pain assessment at rest
Time frame: Day 3
Postoperative Pain assessment at rest
Time frame: Day 7
Postoperative Pain assessment during walking
Time frame: Day 1
Postoperative Pain assessment during walking
Time frame: Day 3
Postoperative Pain assessment during walking
Time frame: Day 7
Postoperative Pain assessment during First defecation
Time frame: Day 7
Non-Opioid Postoperative Medication Use
Time frame: Day 1
Pudendal block procedure duration
Time frame: Hour 2
Sensory block duration
Time frame: Day 7
Length of stay in the PACU
Time frame: Day 1
Total hospital stay duration
Time frame: Day 1
Time to first defecation
Time frame: Day 7
Tolerance
Time frame: Day 7
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 11 Jun 2025.
- Derived from this study: PubMed 41476689Giral T, Maupain O, Elmaleh Y, Huynh D, Ciceron F, Yao K, Devidas P, El Metni A, Kutter J. Ultrasound-guided versus neurostimulation-guided bilateral transperineal pudendal nerve block for analgesia in outpatient haemorrhoid surgery: protocol for a multicentre, randomised, double-blind, non-inferiority trial. BJA Open. 2025 Dec 9;16:100512. doi: 10.1016/j.bjao.2025.100512. eCollection 2025 Dec.
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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.
Thomas GIRAL, MD principal investigator
Hôpital privé Claude Galien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurostimulation and Ultrasound in people with Hemorrhoids, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 11 Jun 2025. 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 France. 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 Thomas GIRAL, MD (01 69 39 15 53 ext. 33, thomasgiral@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain assessment in the Post-Anesthesia Care Unit (PACU) (time frame: Hour 2). 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 NCT07015775, 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 11 Jun 2025.