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

Tampere University Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Nerve Block

Treatments: Drug: Dexamethasone Sodium Phosphate; Drug: Sodium Chloride 9mg/mL; Drug: Ropivacaine Hydrochloride Inj 2 mg/ml

Study type: Interventional

Funder types: Other

Identifiers

NCT03332316

2017-002185-51 (EudraCT Number)

R17104M

Details and patient eligibility

About

Effect of perineural dexamethasone on the duration of popliteal nerve block after ankle/foot surgery

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 4 patient groups, including a placebo group

DEXA0

Placebo Comparator group

Description:

Ropivacaine Hydrochloride Inj 2mg/ml 20 ml and Sodium Chloride 9mg/mL 1 ml perineurally

Treatment:

Drug: Sodium Chloride 9mg/mL

Drug: Ropivacaine Hydrochloride Inj 2 mg/ml

DEXA1

Experimental group

Description:

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

Treatment:

Drug: Sodium Chloride 9mg/mL

Drug: Ropivacaine Hydrochloride Inj 2 mg/ml

Drug: Dexamethasone Sodium Phosphate

DEXA2

Experimental group

Description:

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

Treatment:

Drug: Sodium Chloride 9mg/mL

Drug: Ropivacaine Hydrochloride Inj 2 mg/ml

Drug: Dexamethasone Sodium Phosphate

DEXA4

Experimental group

Description:

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

Treatment:

Drug: Sodium Chloride 9mg/mL

Drug: Ropivacaine Hydrochloride Inj 2 mg/ml

Drug: Dexamethasone Sodium Phosphate