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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004879-23 | EudraCT Number |
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The purpose of this study is to investigate whether dexamethasone as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect using a paired design and bilateral blocks.
The investigators hypothesize that adding dexamethasone to ropivacaine will prolong block duration compared with ropivacaine + placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine + dexamethasone | Experimental | 20 ml ropivacaine 0.5% + 0.5 ml dexamethasone 4 mg7ml |
|
| Ropivacaine + placebo | Placebo Comparator | 20 ml ropivacaine 0.5% + 0.5 ml isotonic saline ad |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine + dexamethasone | Drug | Adductor canal block, single bolus |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in duration of sensory block between dexamethasone and placebo assessed as cold sensation with an alcohol swab | Duration is defined as time from block performance until recovery of cold sensation to an alcohol swab, assessed every hour post-block (and every half hour when pain scores during the tonic heat stimulation test is above 0, except at 2 and 3 hours post block where there will be a break and no assessments will be performed. | 0-36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between dexamethasone and placebo in the duration of a sensory block assessed by pin-prick | Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed). | 0-36 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pia Jæger, MD, PhD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital | Gentofte Municipality | Hellerup | 2900 | Denmark |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine + placebo |
| Drug |
Adductor canal block, single bolus |
|
| Difference between dexamethasone and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test |
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed). Recovery of normal sensation is defined as VAS pain scores ± 10 mm of the pre-block value. |
| 0-36 hours |
| Difference between dexamethasone and placebo in the duration of a sensory block assessed as warmth detection threshold | Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed and only assessed if pain scores during tonic heat stimulation is above 0 ). Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value. | 0-36 hours |
| Difference between dexamethasone and placebo in the duration of a sensory block assessed as heat pain detection threshold | Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed and only assessed if pain scores during tonic heat stimulation is above 0 ). Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value. | 0-36 hours |
| Difference in maximum pain scores between dexamethasone and placebo during block and after recovery of normal sensation | Pain scores during a tonic heat stimulation will be compared at 4 h post block and 1 h after pain scores have returned to the pre-block values. | 0-36 hours |
| D000588 |
| Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |