Analgesia Clinical Trial
— AmbuCineViewOfficial title:
Evaluation of an Immersive Audiovisual Distraction Device Impact on Peroperative Opioid Consumption. A Prospective Randomized Controlled Study
Verified date | January 2021 |
Source | University Hospital, Caen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluate the impact of an audiovisual distraction device on the peroperative opioid consumption for outpatient procedures with Remifentanil added to local anesthesia. Half of patients will receive an audiovisual distraction device while the other half not.
Status | Completed |
Enrollment | 200 |
Est. completion date | January 1, 2021 |
Est. primary completion date | January 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patient - Signed consent - Outpatient surgery eligibility - Patient covered by social security Exclusion Criteria: - Unsigned consent - Study participation refusal - Deafness, blindness - Claustrophobia - ANI contraindication (atrial fibrillation, pace maker, severe autonomic system dysfunction) - Contraindication or impossibility to use the audiovisual distraction device |
Country | Name | City | State |
---|---|---|---|
France | Caen University Hospital | Caen | Calvados |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
Abend R, Dan O, Maoz K, Raz S, Bar-Haim Y. Reliability, validity and sensitivity of a computerized visual analog scale measuring state anxiety. J Behav Ther Exp Psychiatry. 2014 Dec;45(4):447-53. doi: 10.1016/j.jbtep.2014.06.004. Epub 2014 Jun 18. — View Citation
Boselli E, Musellec H, Martin L, Bernard F, Fusco N, Guillou N, Hugot P, Paqueron X, Yven T, Virot C. Effects of hypnosis on the relative parasympathetic tone assessed by ANI (Analgesia/Nociception Index) in healthy volunteers: a prospective observational study. J Clin Monit Comput. 2018 Jun;32(3):487-492. doi: 10.1007/s10877-017-0056-5. Epub 2017 Aug 20. — View Citation
Boselli E. Interest of Analgesia/Nociception Index (ANI) for monitoring the relative parasympathetic tone in anesthetized and awake patients. Douleurs (Paris) (2018)
Boselli et al. Analgesia monitoring using Analgesia/Nociception Index: Results of clinical studies in awake and anesthetized patients. Le Praticien en anesthésie réanimation. 2015;19:78-86
Eccleston C, Crombez G. Pain demands attention: a cognitive-affective model of the interruptive function of pain. Psychol Bull. 1999 May;125(3):356-66. Review. — View Citation
Facco E, Stellini E, Bacci C, Manani G, Pavan C, Cavallin F, Zanette G. Validation of visual analogue scale for anxiety (VAS-A) in preanesthesia evaluation. Minerva Anestesiol. 2013 Dec;79(12):1389-95. Epub 2013 Jul 9. — View Citation
Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137. Review. — View Citation
Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. — View Citation
Issa R, Julien M, Décary E, Verdonck O, Fortier LP, Drolet P, Richebé P. Evaluation of the analgesia nociception index (ANI) in healthy awake volunteers. Can J Anaesth. 2017 Aug;64(8):828-835. doi: 10.1007/s12630-017-0887-z. Epub 2017 Apr 21. — View Citation
Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. — View Citation
Le Guen M, Jeanne M, Sievert K, Al Moubarik M, Chazot T, Laloë PA, Dreyfus JF, Fischler M. The Analgesia Nociception Index: a pilot study to evaluation of a new pain parameter during labor. Int J Obstet Anesth. 2012 Apr;21(2):146-51. doi: 10.1016/j.ijoa.2012.01.001. Epub 2012 Feb 21. — View Citation
Lee DW, Chan AC, Wong SK, Fung TM, Li AC, Chan SK, Mui LM, Ng EK, Chung SC. Can visual distraction decrease the dose of patient-controlled sedation required during colonoscopy? A prospective randomized controlled trial. Endoscopy. 2004 Mar;36(3):197-201. — View Citation
Logier R, Jeanne M, De Jonckheere J, Dassonneville A, Delecroix M, Tavernier B. PhysioDoloris: a monitoring device for analgesia / nociception balance evaluation using heart rate variability analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:1194-7. doi: 10.1109/IEMBS.2010.5625971. — View Citation
Marsdin E, Noble JG, Reynard JM, Turney BW. Audiovisual distraction reduces pain perception during shockwave lithotripsy. J Endourol. 2012 May;26(5):531-4. doi: 10.1089/end.2011.0430. Epub 2012 Feb 8. — View Citation
Maurice-Szamburski A, Loundou A, Capdevila X, Bruder N, Auquier P. Validation of the French version of the Amsterdam preoperative anxiety and information scale (APAIS). Health Qual Life Outcomes. 2013 Oct 7;11:166. doi: 10.1186/1477-7525-11-166. — View Citation
Papaioannou V, Chouvarda I, Gaertner E, Benyamina M, Ferry A, Maurel V, Soussi S, Blet A, Chaouat M, Plaud B, Mebazaa A, Legrand M; PRONOBURN Group. Heart rate variability and cardiac baroreflex inhibition-derived index predicts pain perception in burn patients. Burns. 2016 Nov;42(7):1445-1454. doi: 10.1016/j.burns.2016.04.017. Epub 2016 May 8. — View Citation
Wismeijer AA, Vingerhoets AJ. The use of virtual reality and audiovisual eyeglass systems as adjunct analgesic techniques: a review of the literature. Ann Behav Med. 2005 Dec;30(3):268-78. Review. — View Citation
Yi P, Pryzbylkowski P. Opioid Induced Hyperalgesia. Pain Med. 2015 Oct;16 Suppl 1:S32-6. doi: 10.1111/pme.12914. Review. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative Remifentanil dose | µg/kg/min | 1 hour | |
Secondary | Preoperative pain measured with a numeric pain rating scale (NRS) | Numeric pain rating scale (0 = No pain to 10 = Worst pain imaginable) | 1 hour | |
Secondary | Preoperative anxiety measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) | APAIS measures the need-for-information with 6 items. Each one is rated from 1 = Not at all to 5 = Extremely. There is positive and significant correlation between the ned-for-information and anxiety. | 1 hour | |
Secondary | Preoperative anxiety measured by a visual analogue scale (VAS) | Visual analogue scale is a 100mm horizontal line. At the left hand (0mm) the statement "not anxious at all" and at the right hand (100mm) the statement "most anxious I can imagine" | 1 hour | |
Secondary | Per operative Analgesia nociception index (ANI) value | From 0 = Predominant sympathetic tone, pain and anxiety to 100 = Predominant parasympathetic tone, good analgesia.
Negative linear Relationship between analgesia nociception index and pain scores |
1 hour | |
Secondary | Post operative anxiety measured by a visual analogue scale (VAS) | Visual analogue scale is a 100mm horizontal line. At the left hand (0mm) the statement "not anxious at all" and at the right hand (100mm) the statement "most anxious I can imagine" | 1 hour | |
Secondary | Postoperative pain measured with a numeric pain rating scale (NRS) | Numeric pain rating scale (0 = No pain to 10 = Worst pain imaginable) | 1 hour |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05534230 -
Dexmedetomidine for Pain Reduction in CABG
|
N/A | |
Recruiting |
NCT06275698 -
HONEY for the Treatment of POst-Tonsillectomy Pain
|
N/A | |
Recruiting |
NCT04436224 -
Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation
|
Phase 4 | |
Not yet recruiting |
NCT04548323 -
Hypoalgesic Effects of Walking and Running Imagined
|
||
Completed |
NCT06054945 -
Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
|
||
Completed |
NCT04394481 -
Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery
|
Phase 4 | |
Completed |
NCT04690647 -
The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement.
|
N/A | |
Completed |
NCT05034601 -
ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure
|
N/A | |
Completed |
NCT03740815 -
Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection
|
N/A | |
Recruiting |
NCT05454202 -
Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
|
||
Recruiting |
NCT04554186 -
Serratus Anterior Plane Block Versus Thoracic Paravertebral Block.
|
N/A | |
Suspended |
NCT04860635 -
Safety of F14 Following Total Knee Replacement
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT06393777 -
Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion
|
N/A | |
Not yet recruiting |
NCT04519463 -
The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing
|
Early Phase 1 | |
Completed |
NCT02916342 -
Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks
|
Phase 4 | |
Completed |
NCT03206554 -
Local Infiltration Analgesia in Total Knee Arthroplasty
|
Phase 2 | |
Not yet recruiting |
NCT02549118 -
Tenoxicam for Intrapartum Analgesia
|
Phase 2 | |
Not yet recruiting |
NCT02190760 -
Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block.
|
N/A | |
Completed |
NCT01789606 -
Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet
|
Phase 3 | |
Completed |
NCT01299584 -
ULTIVA Post Marketing Surveillance
|
N/A |