Studies
| Study First Submitted Date | 2019-07-17 |
| Study First Posted Date | 2019-07-19 |
| Last Update Posted Date | 2019-10-21 |
| Start Month Year | July 26, 2019 |
| Primary Completion Month Year | October 16, 2019 |
| Verification Month Year | October 2019 |
| Verification Date | 2019-10-31 |
| Last Update Posted Date | 2019-10-21 |
Detailed Descriptions
| Sequence: | 20849963 |
| Description | In this doubleblind randomized pilot trial, patients will receive one of five possible combinations to assess which medication leads to the best medication during placement of regional anaesthesia. This assessement includes NRS, patients’ satisfaction and wellbeing. The tested substances will be administered intravenously (fentanyl-bolus, remifentanil-infusion, clonidine-bolus) or transcutaneously (EMLA salve). The fifth combination will be the control group with only placebo medication. We expected to get first information for objectifying analgosedation during placement of regional anaesthesia for the conduction of further studies in this field. |
Facilities
| Sequence: | 201273898 |
| Name | Medical University Hospital LKH Graz |
| City | Graz |
| Zip | 8036 |
| Country | Austria |
Browse Interventions
| Sequence: | 96586884 | Sequence: | 96586885 | Sequence: | 96586886 | Sequence: | 96586887 | Sequence: | 96586888 | Sequence: | 96586889 | Sequence: | 96586890 | Sequence: | 96586891 | Sequence: | 96586892 | Sequence: | 96586893 | Sequence: | 96586894 | Sequence: | 96586895 | Sequence: | 96586896 | Sequence: | 96586897 | Sequence: | 96586898 | Sequence: | 96586899 | Sequence: | 96586900 | Sequence: | 96586901 | Sequence: | 96586902 | Sequence: | 96586903 | Sequence: | 96586904 | Sequence: | 96586905 | Sequence: | 96586906 | Sequence: | 96586907 | Sequence: | 96586908 | Sequence: | 96586909 |
| Mesh Term | Clonidine | Mesh Term | Fentanyl | Mesh Term | Remifentanil | Mesh Term | Lidocaine, Prilocaine Drug Combination | Mesh Term | Analgesics, Opioid | Mesh Term | Narcotics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Analgesics | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Adjuvants, Anesthesia | Mesh Term | Anesthetics, Intravenous | Mesh Term | Anesthetics, General | Mesh Term | Anesthetics | Mesh Term | Antihypertensive Agents | Mesh Term | Sympatholytics | Mesh Term | Autonomic Agents | Mesh Term | Adrenergic alpha-2 Receptor Agonists | Mesh Term | Adrenergic alpha-Agonists | Mesh Term | Adrenergic Agonists | Mesh Term | Adrenergic Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Anesthetics, Local | Mesh Term | Anesthetics, Combined |
| Downcase Mesh Term | clonidine | Downcase Mesh Term | fentanyl | Downcase Mesh Term | remifentanil | Downcase Mesh Term | lidocaine, prilocaine drug combination | Downcase Mesh Term | analgesics, opioid | Downcase Mesh Term | narcotics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | analgesics | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | adjuvants, anesthesia | Downcase Mesh Term | anesthetics, intravenous | Downcase Mesh Term | anesthetics, general | Downcase Mesh Term | anesthetics | Downcase Mesh Term | antihypertensive agents | Downcase Mesh Term | sympatholytics | Downcase Mesh Term | autonomic agents | Downcase Mesh Term | adrenergic alpha-2 receptor agonists | Downcase Mesh Term | adrenergic alpha-agonists | Downcase Mesh Term | adrenergic agonists | Downcase Mesh Term | adrenergic agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | anesthetics, local | Downcase Mesh Term | anesthetics, combined |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 52501215 | Sequence: | 52501216 | Sequence: | 52501217 |
| Name | Knee Arthropathy | Name | Hip Arthritis | Name | Fractures, Closed |
| Downcase Name | knee arthropathy | Downcase Name | hip arthritis | Downcase Name | fractures, closed |
Id Information
| Sequence: | 40394750 |
| Id Source | org_study_id |
| Id Value | 2 |
Countries
| Sequence: | 42831394 |
| Name | Austria |
| Removed | False |
Design Groups
| Sequence: | 55957478 | Sequence: | 55957479 | Sequence: | 55957480 | Sequence: | 55957481 | Sequence: | 55957482 |
| Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Placebo Comparator |
| Title | Fentanyl i.v. (intravenously) | Title | Remifentanil i.v. | Title | Clonidine i.v. | Title | EMLA salve | Title | Placebo |
| Description | Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve) | Description | Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve) | Description | Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve) | Description | Patients will be administered the medication (salve) and additionally will be administered i.v. saline as placebo | Description | Patients will be administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve) |
Interventions
| Sequence: | 52809424 | Sequence: | 52809425 | Sequence: | 52809426 | Sequence: | 52809427 | Sequence: | 52809423 | Sequence: | 52809428 |
| Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
| Name | Remifentanil | Name | Clonidine | Name | EMLA Cream | Name | Placebo iv | Name | Fentanyl | Name | Placebo salve |
| Description | Weight adapted drug application | Description | Weight adapted drug application | Description | Salve application on the body part where the regional anaesthesia will be administered | Description | i.v. administration of 0,9% NaCl | Description | Weight adapted drug application | Description | Skin protection salve (placebo salve) application on the body part where the regional anaesthesia will be administered |
Design Outcomes
| Sequence: | 178611731 | Sequence: | 178611732 | Sequence: | 178611733 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Pain intensity during placement of the regional anaesthesia | Measure | Patients’ wellbeing | Measure | Complication rate (delirium, allergic reactions, cardiopulmonary decompensation) |
| Time Frame | 1 day | Time Frame | 1 day | Time Frame | Through study completion, an average of 1 day |
| Description | Pain assessment during placement of the regional anaesthesia with the Numeric Rating Scale (NRS 1 to 10, with 1=lowest pain score, 10=highest pain score). Lower NRS describes a better outcome. | Description | Wellbeing assessment during placement of the regional anaesthesia with the anaesthesiological questionnaire (ANP anaesthesiological Questionnaire is a self-rating method for the assessment of postoperative complaints, patient wellbeing and satisfaction. The rating scales from 0 to 3, with 0=”none” and 3=”strongly”). Higher wellbeing values represent a better outcome. | Description | Complications on operation day will be recorded and compared between the treatment groups. |
Browse Conditions
| Sequence: | 194746175 | Sequence: | 194746176 | Sequence: | 194746177 |
| Mesh Term | Fractures, Closed | Mesh Term | Fractures, Bone | Mesh Term | Wounds and Injuries |
| Downcase Mesh Term | fractures, closed | Downcase Mesh Term | fractures, bone | Downcase Mesh Term | wounds and injuries |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48625114 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Medical University of Graz |
Overall Officials
| Sequence: | 29457632 |
| Role | Principal Investigator |
| Name | Gregor A Schittek, MD |
| Affiliation | Medical University of Graz |
Design Group Interventions
| Sequence: | 68598912 | Sequence: | 68598913 | Sequence: | 68598914 | Sequence: | 68598915 | Sequence: | 68598916 | Sequence: | 68598917 | Sequence: | 68598918 | Sequence: | 68598919 | Sequence: | 68598920 | Sequence: | 68598921 |
| Design Group Id | 55957478 | Design Group Id | 55957479 | Design Group Id | 55957480 | Design Group Id | 55957481 | Design Group Id | 55957481 | Design Group Id | 55957482 | Design Group Id | 55957480 | Design Group Id | 55957478 | Design Group Id | 55957482 | Design Group Id | 55957479 |
| Intervention Id | 52809423 | Intervention Id | 52809424 | Intervention Id | 52809425 | Intervention Id | 52809426 | Intervention Id | 52809427 | Intervention Id | 52809427 | Intervention Id | 52809428 | Intervention Id | 52809428 | Intervention Id | 52809428 | Intervention Id | 52809428 |
Eligibilities
| Sequence: | 30953701 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria:
Adult patients planed electively for orthopedic surgery Exclusion Criteria: Missing patient’s consent |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253899265 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2019 |
| Actual Duration | 2 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 2 |
Designs
| Sequence: | 30699283 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | Quadruple |
| Subject Masked | True |
| Caregiver Masked | True |
| Investigator Masked | True |
| Outcomes Assessor Masked | True |
Responsible Parties
| Sequence: | 29066048 |
| Responsible Party Type | Sponsor |
Ipd Information Types
| Sequence: | 3361322 | Sequence: | 3361323 | Sequence: | 3361324 |
| Name | Study Protocol | Name | Statistical Analysis Plan (SAP) | Name | Informed Consent Form (ICF) |