Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Ankle Surgery
Study Details
Study Description
Brief Summary
Effect of perineural dexamethasone on the duration of popliteal nerve block after ankle/foot surgery
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: DEXA0 Ropivacaine Hydrochloride Inj 2mg/ml 20 ml and Sodium Chloride 9mg/mL 1 ml perineurally |
Drug: Ropivacaine Hydrochloride Inj 2 mg/ml
Ropivacaine injection
Drug: Sodium Chloride 9mg/mL
Sodium Chloride injection
Other Names:
|
| Experimental: DEXA1 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
Dexamethasone injection
Other Names:
Drug: Ropivacaine Hydrochloride Inj 2 mg/ml
Ropivacaine injection
Drug: Sodium Chloride 9mg/mL
Sodium Chloride injection
Other Names:
|
| Experimental: DEXA2 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
Dexamethasone injection
Other Names:
Drug: Ropivacaine Hydrochloride Inj 2 mg/ml
Ropivacaine injection
Drug: Sodium Chloride 9mg/mL
Sodium Chloride injection
Other Names:
|
| Experimental: DEXA4 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
Dexamethasone injection
Other Names:
Drug: Ropivacaine Hydrochloride Inj 2 mg/ml
Ropivacaine injection
Drug: Sodium Chloride 9mg/mL
Sodium Chloride injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- First need of opiate [48 hours]
Time after surgery when the patient needs opiate for the first time
Secondary Outcome Measures
- Opiate consumption [48 hours]
Total opiate consumption after surgery
- Pain [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]
Numeric rating scale NRS 0-10
- Mobilisation [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]
Toe movement every 4 hour during hospitalization
- Blood glucose [postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours]
Blood glucose every 4 hour during hospitalization
Other Outcome Measures
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tampere University Hospital | Tampere | Finland | 33521 |
Sponsors and Collaborators
- Tampere University Hospital
Investigators
- Study Director: Maija-Liisa Kalliomäki, PhD, Tampere University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R17104M
- 2017-002185-51