Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Ankle Surgery

Study Overview
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Brief Summary
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Effect of perineural dexamethasone on the duration of popliteal nerve block after ankle/foot surgery

Detailed Description
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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.

Official Title
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Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Ankle Surgery

Conditions
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Postoperative Pain, Nerve Block

Intervention / Treatment
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* Drug: Dexamethasone Sodium Phosphate
* Drug: Ropivacaine Hydrochloride Inj 2 mg/ml
* Drug: Sodium Chloride 9mg/mL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: DEXA0<br>Ropivacaine Hydrochloride Inj 2mg/ml 20 ml and Sodium Chloride 9mg/mL 1 ml perineurally | Drug: Ropivacaine Hydrochloride Inj 2 mg/ml<br>* Ropivacaine injection<br>Drug: Sodium Chloride 9mg/mL<br>* Sodium Chloride injection<br>* Other names: Saline;|
| Experimental: DEXA1<br>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 | Drug: Dexamethasone Sodium Phosphate<br>* Dexamethasone injection<br>* Other names: Oradexon;Drug: Ropivacaine Hydrochloride Inj 2 mg/ml<br>* Ropivacaine injection<br>Drug: Sodium Chloride 9mg/mL<br>* Sodium Chloride injection<br>* Other names: Saline;|
| Experimental: DEXA2<br>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 | Drug: Dexamethasone Sodium Phosphate<br>* Dexamethasone injection<br>* Other names: Oradexon;Drug: Ropivacaine Hydrochloride Inj 2 mg/ml<br>* Ropivacaine injection<br>Drug: Sodium Chloride 9mg/mL<br>* Sodium Chloride injection<br>* Other names: Saline;|
| Experimental: DEXA4<br>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 | Drug: Dexamethasone Sodium Phosphate<br>* Dexamethasone injection<br>* Other names: Oradexon;Drug: Ropivacaine Hydrochloride Inj 2 mg/ml<br>* Ropivacaine injection<br>Drug: Sodium Chloride 9mg/mL<br>* Sodium Chloride injection<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First need of opiate | Time after surgery when the patient needs opiate for the first time | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |