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

NCT ID: NCT03332316

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-02

Study Completion Date

2023-11-21

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.

Conditions

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Postoperative Pain Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DEXA0

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

Group Type PLACEBO_COMPARATOR

Ropivacaine Hydrochloride Inj 2 mg/ml

Intervention Type DRUG

Ropivacaine injection

Sodium Chloride 9mg/mL

Intervention Type DRUG

Sodium Chloride injection

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

Group Type EXPERIMENTAL

Dexamethasone Sodium Phosphate

Intervention Type DRUG

Dexamethasone injection

Ropivacaine Hydrochloride Inj 2 mg/ml

Intervention Type DRUG

Ropivacaine injection

Sodium Chloride 9mg/mL

Intervention Type DRUG

Sodium Chloride injection

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

Group Type EXPERIMENTAL

Dexamethasone Sodium Phosphate

Intervention Type DRUG

Dexamethasone injection

Ropivacaine Hydrochloride Inj 2 mg/ml

Intervention Type DRUG

Ropivacaine injection

Sodium Chloride 9mg/mL

Intervention Type DRUG

Sodium Chloride injection

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

Group Type EXPERIMENTAL

Dexamethasone Sodium Phosphate

Intervention Type DRUG

Dexamethasone injection

Ropivacaine Hydrochloride Inj 2 mg/ml

Intervention Type DRUG

Ropivacaine injection

Sodium Chloride 9mg/mL

Intervention Type DRUG

Sodium Chloride injection

Interventions

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Dexamethasone Sodium Phosphate

Dexamethasone injection

Intervention Type DRUG

Ropivacaine Hydrochloride Inj 2 mg/ml

Ropivacaine injection

Intervention Type DRUG

Sodium Chloride 9mg/mL

Sodium Chloride injection

Intervention Type DRUG

Other Intervention Names

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Oradexon Saline

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maija-Liisa Kalliomäki, PhD

Role: STUDY_DIRECTOR

Tampere University Hospital

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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2017-002185-51

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R17104M

Identifier Type: -

Identifier Source: org_study_id