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Completed

NCT Number: NCT02351804

Does Perineural Dexamethasone Prolong Duration of a Nerve Block?

The purpose of this study is to investigate whether dexamethasone as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect using a paired design and bilateral blocks.

The investigators hypothesize that adding dexamethasone to ropivacaine will prolong block duration compared with ropivacaine + placebo.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital

Gentofte Municipality, Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • American Society of Anesthesiologists class 1
  • Body Mass Index 18-30

Exclusion criteria

  • Allergy to study medication
  • Earlier trauma or surgery to lower limb
  • Diabetes Mellitus
  • Alcohol or drug abuse
  • Daily intake of opioids or steroids last 4 weeks
  • Daily intake of any analgesics last 48 hours

Treatment and study plan

Ropivacaine + Dexamethasone

Drug

Adductor canal block, single bolus

Ropivacaine + placebo

Drug

Adductor canal block, single bolus

Primary outcomes

  1. Difference in duration of sensory block between dexamethasone and placebo assessed as cold sensation with an alcohol swab

    Time frame: 0-36 hours

    Duration is defined as time from block performance until recovery of cold sensation to an alcohol swab, assessed every hour post-block (and every half hour when pain scores during the tonic heat stimulation test is above 0, except at 2 and 3 hours post block where there will be a break and no assessments will be performed.

Secondary outcomes

  1. Difference between dexamethasone and placebo in the duration of a sensory block assessed by pin-prick

    Time frame: 0-36 hours

    Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed).

  2. Difference between dexamethasone and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test

    Time frame: 0-36 hours

    Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed).

    Recovery of normal sensation is defined as VAS pain scores ± 10 mm of the pre-block value.

  3. Difference between dexamethasone and placebo in the duration of a sensory block assessed as warmth detection threshold

    Time frame: 0-36 hours

    Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed and only assessed if pain scores during tonic heat stimulation is above 0 ).

    Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.

  4. Difference between dexamethasone and placebo in the duration of a sensory block assessed as heat pain detection threshold

    Time frame: 0-36 hours

    Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed and only assessed if pain scores during tonic heat stimulation is above 0 ).

    Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.

  5. Difference in maximum pain scores between dexamethasone and placebo during block and after recovery of normal sensation

    Time frame: 0-36 hours

    Pain scores during a tonic heat stimulation will be compared at 4 h post block and 1 h after pain scores have returned to the pre-block values.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Does Perineural Dexamethasone Prolong Duration of an Adductor Canal Block When Controlling for a Systemic Effect? A Paired, Randomized, Blinded, Study in Healthy Volunteers

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 30, 2015
Registry last updated
Sep 1, 2015

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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