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NCT Number: NCT06185829

Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Paul d'Egine

Champigny-sur-Marne, 94500, France

Location status: Recruiting

Location contact

Mélanie FROMENTIN, MD

CONTACT

[email protected]

01 86 86 66 00 ext. 33

Mélanie FROMENTIN, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Neuroleptanalgesic treatment

Drug

Usual neuroleptanalgesic treatment Hypnovel and Locoregional anesthesia

Other names: Hypnovel

Hypnoanalgesia

Other

Hypnoanalgesia and Locoregional anesthesia

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain intensity assessment

    Time frame: Day 0

    Pain intensity will be assessed using a simple numerical scale (ENS) graduated from 0 (no pain) to 10 (worst pain imaginable).

  2. Pain intensity assessment

    Time frame: Day 2

    Pain intensity will be assessed using a simple numerical scale (ENS) graduated from 0 (no pain) to 10 (worst pain imaginable).

  3. Overall patient satisfaction

    Time frame: Day 0

    Overall patient satisfaction will be assessed using a simple numerical scale (ENS) graduated from 0 (not at all satisfied) to 10 (completely satisfied).

  4. Overall patient satisfaction

    Time frame: Day 2

    Overall patient satisfaction will be assessed using a simple numerical scale (ENS) graduated from 0 (not at all satisfied) to 10 (completely satisfied).

  5. Treatment Safety

    Time frame: Day 2

    The safety will be assessed by collecting data on adverse events occurring during the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Mélanie FROMENTIN, MD

CONTACT

[email protected]

01 86 86 66 00 ext. 33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Vivactis M2Research

Registry information

Acronym: HYPNOMAIN

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 29, 2023
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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