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NCT Number: NCT03332316

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

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

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Key information

Conditions

Postoperative Pain Nerve Block Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tampere University Hospital

Tampere, 33521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone sodium phosphate

Drug

Dexamethasone injection

Other names: Oradexon

Ropivacaine Hydrochloride Inj 2 mg/ml

Drug

Ropivacaine injection

Sodium Chloride 9mg/mL

Drug

Sodium Chloride injection

Other names: Saline

Primary outcomes

  1. First need of opiate

    Time frame: 48 hours

    Time after surgery when the patient needs opiate for the first time

Secondary outcomes

  1. Opiate consumption

    Time frame: 48 hours

    Total opiate consumption after surgery

  2. Pain

    Time frame: 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

  3. Mobilisation

    Time frame: 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

  4. Blood glucose

    Time frame: 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 outcomes

  1. Quality of life (EQ-5D-3L) -query

    Time frame: Before operation and 6-8 weeks, 6 months, 12 months postoperatively

  2. McGill -pain query

    Time frame: Before operation and 6-8 weeks, 6 months, 12 months postoperatively

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Nov 6, 2017
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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