Hand Surgery
Conditions
Brief 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.
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
Interventions
DRUGNeuroleptanalgesic treatment
Usual neuroleptanalgesic treatment Hypnovel and Locoregional anesthesia
OTHERHypnoanalgesia
Hypnoanalgesia and Locoregional anesthesia
Sponsors
Vivactis M2Research
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single-center, prospective, randomized, open label study with two parallel groups of patients. Maximum duration of patient participation = 3 days.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS anxiety score | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity assessment | Day 0 | Pain intensity will be assessed using a simple numerical scale (ENS) graduated from 0 (no pain) to 10 (worst pain imaginable). |
| Overall patient satisfaction | 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). |
| Treatment Safety | Day 2 | The safety will be assessed by collecting data on adverse events occurring during the study. |
Countries
France
Contacts
Primary ContactMélanie FROMENTIN, MD
Outcome results
None listed