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Completed

NCT Number: NCT02818491

Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block

Shoulder surgery is associated with moderate to severe postoperative pain. Interscalene brachial plexus block is considered by many as the gold standard for treating postoperative pain and consists of injecting local anaesthetics close to the nerves of the brachial plexus in the neck. Duration of analgesia is between eight to twelve hours depending on the type of administered drugs. Dexamethasone 4 mg is a steroid routinely injected intravenously in anaesthesia for the prophylaxis of postoperative nausea and vomiting. Recently, different trials have demonstrated that combining 4 to 8 mg of dexamethasone with local anaesthetics for a perineural injection may prolong the duration of analgesia up to 24 hours. In a meta-analysis including 29 trials and 1695 patients, investigators have recently demonstrated through a meta-regression that a dose of 4 mg is sufficient and represents a ceiling dose, without neurological complications. The objective of this multicenter randomised controlled double-blinded trial is to determine the optimal dose of perineural dexamethasone. For that purpose, investigators will include a total of 150 patients divided in 5 groups: local anaesthetics with placebo, or with dexamethasone 1, 2, 3 and 4 mg.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AZ Groeninge Hospital

Kortrijk, 8500, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients scheduled for elective shoulder arthroscopy
  • duration of surgery less than 4 hours

Exclusion criteria

  • allergy to local anaesthetics
  • history of neck surgery
  • history of neck radiotherapy
  • severe respiratory disease
  • diabetic patient
  • chronic pain condition
  • pregnancy
  • patient suffering from cancer
  • patient with addicted disease

Treatment and study plan

Placebo

Drug

Normal saline 0.9% in 2 mls

Dexamethasone 1 mg

Drug

Dexamethasone 1 mg in 2 mls

Dexamethasone 2 MG

Drug

Dexamethasone 2 mg in 2 mls

Dexamethasone 3 mg

Drug

Dexamethasone 3 mg in 2 mls

Dexamethasone 4 mg

Drug

Dexamethasone 4 mg in 2 mls

Ropivacaine 0.5%

Drug

Ropivacaine 0.5% 20 mls

Primary outcomes

  1. Duration of analgesia

    Time frame: 24hour

Secondary outcomes

  1. Duration of motor block

    Time frame: 24hour

  2. Onset time of action of sensory block

    Time frame: 1hour

  3. Onset time of action of motor block

    Time frame: 1hour

  4. Equivalent morphine consumption in postanesthetic care unit

    Time frame: 4hour

  5. Equivalent morphine consumption on postoperative day 1

    Time frame: 24hour

  6. Pain scores at rest in postanesthetic care unit (visual analogue scale, 0-10)

    Time frame: 4hour

  7. Pain scores on movement in postanesthetic care unit (visual analogue scale, 0-10)

    Time frame: 4hour

  8. Pain scores at rest on postoperative day 1 (visual analogue scale, 0-10)

    Time frame: 24hour

  9. Pain scores on movement on postoperative day 1 (visual analogue scale, 0-10)

    Time frame: 24hour

  10. Rate of postoperative nausea and vomiting (PONV)

    Time frame: 24hour

    Presence of PONV (YES/NO)

  11. Rate of pruritus

    Time frame: 24hour

    Presence of pruritus (YES/NO)

  12. Satisfaction score on postoperative day 1 (visual analogue scale, 0-10)

    Time frame: 24hour

  13. Glycemia in postanesthetic care unit (mmol/l)

    Time frame: 4hour

  14. Rate of infection

    Time frame: 24hour

    Presence of infection (YES/NO)

  15. Rate of infection

    Time frame: 7 days

    Presence of infection (YES/NO)

  16. Rate of paresthesia

    Time frame: 7 days

    Presence of paresthesia (YES/NO)

  17. Rate of muscle weakness

    Time frame: 7 days

    Presence of muscle weakness (YES/NO)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block: a Dose-finding Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2016
Registry last updated
Jan 7, 2020

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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