- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02351804
Does Perineural Dexamethasone Prolong Duration of a Nerve Block?
Does Perineural Dexamethasone Prolong Duration of an Adductor Canal Block When Controlling for a Systemic Effect? A Paired, Randomized, Blinded, Study in Healthy Volunteers
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Hellerup
-
Gentofte, Hellerup, Danmark, 2900
- Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Ropivacaine + dexamethasone
20 ml ropivacaine 0.5% + 0.5 ml dexamethasone 4 mg7ml
|
Adductor canal block, single bolus
|
Placebo komparator: Ropivacaine + placebo
20 ml ropivacaine 0.5% + 0.5 ml isotonic saline ad
|
Adductor canal block, single bolus
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Difference in duration of sensory block between dexamethasone and placebo assessed as cold sensation with an alcohol swab
Tidsramme: 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.
|
0-36 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Difference between dexamethasone and placebo in the duration of a sensory block assessed by pin-prick
Tidsramme: 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).
|
0-36 hours
|
Difference between dexamethasone and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test
Tidsramme: 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. |
0-36 hours
|
Difference between dexamethasone and placebo in the duration of a sensory block assessed as warmth detection threshold
Tidsramme: 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. |
0-36 hours
|
Difference between dexamethasone and placebo in the duration of a sensory block assessed as heat pain detection threshold
Tidsramme: 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. |
0-36 hours
|
Difference in maximum pain scores between dexamethasone and placebo during block and after recovery of normal sensation
Tidsramme: 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.
|
0-36 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Pia Jæger, MD, PhD, Rigshospitalet, Denmark
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Depressive midler til centralnervesystemet
- Autonome agenter
- Agenter fra det perifere nervesystem
- Sensoriske systemagenter
- Bedøvelsesmidler
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Antiemetika
- Gastrointestinale midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Bedøvelsesmidler, lokale
- Dexamethason
- Ropivacain
Andre undersøgelses-id-numre
- SM2-PJ-14
- 2014-004879-23 (EudraCT nummer)
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