Hand SurgeryHYPNOMAINNCT06185829
Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery
A study testing Neuroleptanalgesic treatment and Hypnoanalgesia in people with Hand Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
This is a single-center, prospective, randomized, open-label study of two parallel groups of patients undergoing hand surgery: Group 1: locoregional anesthesia + neuroleptanalgesia Group 2: locoregional anesthesia + hypnoanalgesia Therapeutic benefit is based on VAS assessment of intraoperative anxiety. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hand Surgery
- What is being tested?
- Neuroleptanalgesic treatment and Hypnoanalgesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2023to Jan 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
- Patients aged between 18 and 80,
- Patient who has read and signed the consent form for participation in the study after a reflection period (approximately 15 minutes).
- Patient applying for outpatient hand surgery under LRA, such as upper limb trunk blocks (flexor teno synovectomy or endoscopic carpal tunnel surgery).
- Patient requiring sedation associated with locoregional anaesthesia
Who cannot join
- Contraindication to locoregional anaesthesia or to one of the sedatives used in the protocol
- Pregnant or breastfeeding patient or woman of childbearing age without highly effective contraception for the duration of the study (surgically sterile, intrauterine device (> 14 days), hormonal contraception (same dose and formulation for at least 6 months), sexual abstinence. Women of childbearing age, i.e. fertile, are considered to be women after menarche and until they become post-menopausal, unless they are permanently infertile or have undergone surgical sterilisation. A post-menopausal state is defined as the absence of menstruation for 12 months without any other medical cause.
- Patient under court protection, guardianship or curatorship
- Patient not affiliated to the French social security system
- Patients unable to understand informed information and/or give written informed consent: dementia, psychosis, disturbed consciousness, non-French-speaking patients, etc.
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, 1 recruiting
- Recruiting
Hôpital Privé Paul d'Egine
Champigny-sur-Marne, 94500
Mélanie FROMENTIN, MD, 01 86 86 66 00 ext. 33, mfromentin.anesthesierea@gmail.com
Mélanie FROMENTIN, MD
About this study
This is a single-center, prospective, randomized, open-label study of two parallel groups of patients undergoing hand surgery:
Group 1: locoregional anesthesia + neuroleptanalgesia Group 2: locoregional anesthesia + hypnoanalgesia Therapeutic benefit is based on VAS assessment of intraoperative anxiety.
Read the detailed description
In a population of patients undergoing hand surgery and divided into two groups according to the anesthesia protocol administered in addition to locoregional anesthesia by truncal block:
Group 1: neuroleptanalgesia Group 2: hypnoanalgesia Primary objective The main objective of the study is to compare changes in preoperative anxiety between the two groups, between two measurements taken preoperatively (before anxiety management) and at the end of surgery. This level will be evaluated using a VAS rated from 0 to 10.
Secondary objectives
Comparing groups:
- Intraoperative pain
- Total duration of surgical procedure, ICU stay and hospitalization
- Amount of additional sedative treatment administered during surgery
- Post-operative pain
- Patient satisfaction
- Intraoperative and immediate postoperative adverse events
- Conditions
- Hand Surgery
- Being tested
- Neuroleptanalgesic treatment, Hypnoanalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroleptanalgesic treatmentDrug
Also called Hypnovel
Usual neuroleptanalgesic treatment Hypnovel and Locoregional anesthesia
HypnoanalgesiaOther
Hypnoanalgesia and Locoregional anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Usual neuroleptanalgesic treatment | Active comparator | Usual neuroleptanalgesic treatment Hypnovel (1 mg if weight < 60 kg, 1.5 mg if weight between 60 and 80 kg, 2 mg if weight > 80 kg) Receives: Drug: Neuroleptanalgesic treatment |
| Hypnoanalgesia | Experimental | Patients in this group will begin their hypnoanalgesia session with a nurse trained in hypnotherapy. Various methods commonly used in hypnosis (VAKOG, dissociation, diversion, metaphors, etc.) will be selected based on the patient, their personality, their expectations, and their degree of suggestibility. Receives: Other: Hypnoanalgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS anxiety score
Changes in VAS anxiety score between preoperative and intraoperative assessment.
Anxiety will be assessed on a visual analog scale measuring 10 cm (with 0 = no stress - 10 = major stress) and by administering the APAIS scale.
Measured: Day 2
Secondary outcomes (5)
Pain intensity assessment
Pain intensity will be assessed using a simple numerical scale (ENS) graduated from 0 (no pain) to 10 (worst pain imaginable).
Measured: Day 0
Pain intensity assessment
Pain intensity will be assessed using a simple numerical scale (ENS) graduated from 0 (no pain) to 10 (worst pain imaginable).
Measured: Day 2
Overall patient satisfaction
Overall patient satisfaction will be assessed using a simple numerical scale (ENS) graduated from 0 (not at all satisfied) to 10 (completely satisfied).
Measured: Day 0
Overall patient satisfaction
Overall patient satisfaction will be assessed using a simple numerical scale (ENS) graduated from 0 (not at all satisfied) to 10 (completely satisfied).
Measured: Day 2
Treatment Safety
The safety will be assessed by collecting data on adverse events occurring during the study.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start19 Oct 2023
- Primary completionNov 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand SurgeryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, prospective, randomized, open label study with two parallel groups of patients. Maximum duration of patient participation = 3 days.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Vivactis M2Research
- Responsible party
- Sponsor
- Investigators
- Mélanie FROMENTIN, MD, Principal investigator, Hôpital Privé Paul d'Egine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185829
- Sponsor's protocol ID
- 2023-A00880-45
- Acronym
- HYPNOMAIN
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2023
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery
- ClinicalTrials.gov ID
- NCT06185829
- Acronym / sponsor ID
- HYPNOMAIN / 2023-A00880-45
- Conditions
- Hand Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Vivactis M2Research
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 Dec 2023 (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.
This is a single-center, prospective, randomized, open-label study of two parallel groups of patients undergoing hand surgery:
Group 1: locoregional anesthesia + neuroleptanalgesia Group 2: locoregional anesthesia + hypnoanalgesia Therapeutic benefit is based on VAS assessment of intraoperative anxiety.
Detailed description
In a population of patients undergoing hand surgery and divided into two groups according to the anesthesia protocol administered in addition to locoregional anesthesia by truncal block:
Group 1: neuroleptanalgesia Group 2: hypnoanalgesia Primary objective The main objective of the study is to compare changes in preoperative anxiety between the two groups, between two measurements taken preoperatively (before anxiety management) and at the end of surgery. This level will be evaluated using a VAS rated from 0 to 10.
Secondary objectives
Comparing groups:
- Intraoperative pain
- Total duration of surgical procedure, ICU stay and hospitalization
- Amount of additional sedative treatment administered during surgery
- Post-operative pain
- Patient satisfaction
- Intraoperative and immediate postoperative adverse events
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, prospective, randomized, open label study with two parallel groups of patients. Maximum duration of patient participation = 3 days.
| Arm | Type | Receives |
|---|---|---|
| Usual neuroleptanalgesic treatment | Active comparator | Drug: Neuroleptanalgesic treatmentUsual neuroleptanalgesic treatment Hypnovel (1 mg if weight < 60 kg, 1.5 mg if weight between 60 and 80 kg, 2 mg if weight > 80 kg) |
| Hypnoanalgesia | Experimental | Other: HypnoanalgesiaPatients in this group will begin their hypnoanalgesia session with a nurse trained in hypnotherapy. Various methods commonly used in hypnosis (VAKOG, dissociation, diversion, metaphors, etc.) will be selected based on the patient, their personality, their expectations, and their degree of suggestibility. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 18 and 80,
- Patient who has read and signed the consent form for participation in the study after a reflection period (approximately 15 minutes).
- Patient applying for outpatient hand surgery under LRA, such as upper limb trunk blocks (flexor teno synovectomy or endoscopic carpal tunnel surgery).
- Patient requiring sedation associated with locoregional anaesthesia
Key exclusion criteria (5 listed)
- Contraindication to locoregional anaesthesia or to one of the sedatives used in the protocol
- Pregnant or breastfeeding patient or woman of childbearing age without highly effective contraception for the duration of the study (surgically sterile, intrauterine device (> 14 days), hormonal contraception (same dose and formulation for at least 6 months), sexual abstinence. Women of childbearing age, i.e. fertile, are considered to be women after menarche and until they become post-menopausal, unless they are permanently infertile or have undergone surgical sterilisation. A post-menopausal state is defined as the absence of menstruation for 12 months without any other medical cause.
- Patient under court protection, guardianship or curatorship
- Patient not affiliated to the French social security system
- Patients unable to understand informed information and/or give written informed consent: dementia, psychosis, disturbed consciousness, non-French-speaking patients, etc.
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 |
|---|---|---|
| Neuroleptanalgesic treatmentAlso: HypnovelUsual neuroleptanalgesic treatment Hypnovel and Locoregional anesthesia | Drug | Usual neuroleptanalgesic treatment |
| HypnoanalgesiaHypnoanalgesia and Locoregional anesthesia | Other | Hypnoanalgesia |
Primary outcome
VAS anxiety score
Time frame: Day 2
Changes in VAS anxiety score between preoperative and intraoperative assessment. Anxiety will be assessed on a visual analog scale measuring 10 cm (with 0 = no stress - 10 = major stress) and by administering the APAIS scale.
5 secondary outcomes
Pain intensity assessment
Time frame: Day 0
Pain intensity assessment
Time frame: Day 2
Overall patient satisfaction
Time frame: Day 0
Overall patient satisfaction
Time frame: Day 2
Treatment Safety
Time frame: Day 2
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 9 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Mélanie FROMENTIN, MD principal investigator
Hôpital Privé Paul d'Egine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroleptanalgesic treatment and Hypnoanalgesia in people with Hand Surgery, 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 4 inclusion and 5 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 9 Dec 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 Mélanie FROMENTIN, MD (01 86 86 66 00 ext. 33, mfromentin.anesthesierea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS anxiety score (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2025.