Mepivacain versus bupivacain begyndelsestid i ultralydsvejledte ankelblokke
Begyndelse af sensorisk blokade i ultralydsstyret ankelblokering med mepivacain versus bupivacain: et randomiseret ikke-mindreværds klinisk forsøg
The purpose of this research is to determine if both local anesthetics (mepivacaine and bupivacaine) are similar in their onset of sensory block to assess the efficiency of ultrasound-guided ankle blocks in our practice. Currently it is the standard of care to perform ankles blocks with both mepivacaine and bupivacaine. However, given similarity in their safety profile researchers would like to compare if one is non-inferior to the other in terms of onset time of ankle block.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic in Rochester
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age greater than or equal to 18 years old.
- Patients who provide informed consent to participate.
- Patients undergoing foot surgery who require a peripheral nerve block of the ankle as primary anesthesia.
- ASA (American Society of Anesthesiology) Physical Status Classification I - III.
Exclusion Criteria:
- Inability to consent.
- Allergy to local anesthetic.
- Infection at site of injection.
- Pregnancy.
- Coagulopathy.
- Hepatic or renal failure.
- Preexisting neuropathy in operative limb.
- Planned spinal anesthetic or general anesthesia.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Mepivacaine group
Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with mepivacaine prior to undergoing foot surgery |
Up to two 30 ml vials of mepivacaine 1.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves |
|
Aktiv komparator: Bupivacaine group
Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with bupivacaine prior to undergoing foot surgery |
Up to two 30 ml vials of bupivacaine 0.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Onset of sensory Blockage
Tidsramme: 20 minutes
|
Time in minutes for successful surgical sensory blockade following the ankle block |
20 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Block Failure
Tidsramme: 20 minutes
|
Number of subjects to experience block failure as defined as opioid administration operatively and /or conversion to general anesthesia |
20 minutes
|
|
Pain Scores
Tidsramme: Post-procedural, approximately 2-4 hours
|
Pain scores in post-anesthesia care unit (PACU) will be obtained using the numerical rating scale (0-10 point scale with 0 representing no pain and 10 representing the worst possible pain) |
Post-procedural, approximately 2-4 hours
|
|
Total opioid received intra-operatively
Tidsramme: Intra-operatively, approximately 4-6 hours
|
Total amount of opioid received intra-operatively |
Intra-operatively, approximately 4-6 hours
|
|
Time to first opioid use
Tidsramme: 24 hours
|
Time measured in minutes to the first opioid use |
24 hours
|
|
Number of complications
Tidsramme: 24 hour
|
Total number of procedural complications |
24 hour
|
|
Total anesthesia-related time
Tidsramme: 20 minutes
|
Measured in minutes, defined as performance time plus onset time of local anesthesia |
20 minutes
|
|
Overall Benefit of Analgesia Score (OBAS)
Tidsramme: 24 hours after discharge
|
Seven questions to access pain intensity, adverse effects and satisfaction with treatment. Possible score range from 0 to 24, with higher scores indicating worse outcome |
24 hours after discharge
|
|
Total opioid use after discharge
Tidsramme: 24 hours after discharge
|
Total amount of opioids used used for pain control after discharge |
24 hours after discharge
|
|
Duration of the ankle block
Tidsramme: 24 hours after discharge
|
Length of time measured in minutes the patient to felt until the ankle block completely wore off |
24 hours after discharge
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Bridget Pulos, MD, Mayo Clinic
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 22-000140
Plan for individuelle deltagerdata (IPD)
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