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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002185-51 | EudraCT Number |
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Effect of perineural dexamethasone on the duration of popliteal nerve block after ankle/foot surgery
This study is proposed to explore the effect of perineural dexamethasone on the duration of popliteal nerve block for analgesia after ankle surgery.
After ankle or foot arthrodesis patients need a good analgesia. Nevertheless early mobilisation and discharge are important for the healing process after surgery. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe. Perineural dexamethasone added to local anesthetic prolongs the duration of analgesia of the perineural nerve block.
The perineural use of dexamethasone is still off-label. There is a ongoing discussion of which has better benefits, intravenous or perineural dexamethasone.
There are multiple research where the intravenous and perineural dexamethasone use has compared, but there is still a limited amount of research of low dose perineural dexamethasone versus intravenous dexamethasone.
In this study investigators compare different doses of perineural dexamethasone added to ropivacaine 2 mg/ml 20ml. After arthrodesis under spinal anaesthesia the patients receive popliteal block ropivacaine 2 mg/ml 20 ml and dexamethasone of different doses. Groups 1 to 4 has dexamethasone doses 0, 2mg, 3mg or 4 mg.
After the popliteal nerve block investigators follow postoperative pain, opiate consumption, mobilisation and long term quality of life.
Investigators goal is to find a dexamethasone dose which is as low as possible but at the same time covers the need for a good pain relief and fast recovery postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEXA0 | Placebo Comparator | Ropivacaine Hydrochloride Inj 2mg/ml 20 ml and Sodium Chloride 9mg/mL 1 ml perineurally |
|
| DEXA1 | Experimental | Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,2 ml and Sodium Chloride 9mg/mL 0,8 ml perineurally |
|
| DEXA2 | Experimental | Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,4 ml and Sodium Chloride 9mg/mL 0,6 ml perineurally |
|
| DEXA4 | Experimental | Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,8 ml and Sodium Chloride 9mg/mL 0,2 ml perineurally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Sodium Phosphate | Drug | Dexamethasone injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| First need of opiate | Time after surgery when the patient needs opiate for the first time | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Opiate consumption | Total opiate consumption after surgery | 48 hours |
| Pain | Numeric rating scale NRS 0-10 | postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 28 hours, 32 hours, at 36 hours, at 40 hours, at 44 hours, at 48 hours,seventh postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (EQ-5D-3L) -query | Before operation and 6-8 weeks, 6 months, 12 months postoperatively | |
| McGill -pain query | Before operation and 6-8 weeks, 6 months, 12 months postoperatively |
Inclusion Criteria:
Adult people under ankle/foot arthrodesis as a curative therapy of ankle arthrosis or situation after ankle injury or malposition
Exclusion Criteria:
Age under 18 years Complicated diabetes mellitus Lack of finnish language skill and/or co-operation Chronic pain Steroid medication in regular use
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| Name | Affiliation | Role |
|---|---|---|
| Maija-Liisa Kalliomäki, PhD | Tampere University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | 33521 | Finland |
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| Ropivacaine Hydrochloride Inj 2 mg/ml | Drug | Ropivacaine injection |
|
| Sodium Chloride 9mg/mL | Drug | Sodium Chloride injection |
|
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| Mobilisation | Toe movement every 4 hour during hospitalization | postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 28 hours, 32 hours, at 36 hours, at 40 hours, at 44 hours, at 48 hours |
| Blood glucose | Blood glucose every 4 hour during hospitalization | postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C004180 | dexamethasone 21-phosphate |
| D003907 | Dexamethasone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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