- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02008617
Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing ACL Reconstruction
Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Femoral nerve blocks are commonly used to provide postoperative analgesia for ACL surgery. The limitation of these blocks is the incomplete analgesia they provide of the knee joint subjecting the patient to posterior knee pain. As a result, some of these patients receive rescue sciatic blocks in the postoperative care unit to cover posterior knee pain. The sciatic block provides excellent analgesia for the posterior knee; however its blockade invariably affects other territories of the sciatic nerve such as the lower leg and foot. For ACL surgery, the loss of sensation and/or motor strength to this area is unnecessary and may make ambulation more difficult. The ability to ambulate with minimal assistance may be more important for a patient undergoing an outpatient surgery when compared to an inpatient surgery.
At the posterior knee, the sciatic nerve branches off into the tibial and common peroneal nerves which give rise to sensory fibers that innervate the posterior knee. We propose targeting these terminal fibers in the popliteal fossa by infiltrating local anesthetic between the distal femoral shaft and popliteal artery thereby providing posterior knee analgesia without affecting the lower leg.This application of this block has not been studied in patients having ACL surgery. A single interim analysis is scheduled after the data for 50 cases are available.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Northwestern University Feinberg School of Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- patients who are presenting for ACL reconstruction
- candidates for peripheral nerve blocks patients
- ASA 1-3
Exclusion Criteria:
- Patient refusal
- ASA Classification of 4 or higher
- Pre-existing neuropathy in the femoral or sciatic distribution
- Coagulopathy
- Infection at the site
- Non-English speaking or non-reading patients
- Chronic opioid use (>3months)
- Pregnancy
- Any other contra-indication to regional anesthesia
- Failed femoral nerve block
- Sciatic nerve block placed due to severe pain not managed by intravenous and oral agents.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Study Drug
Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000 (Study Drug)
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30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Andre navn:
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Sham-komparator: Preservative free normal saline
Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
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Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Opioid Consumption
Tidsramme: 24 hours
|
Opioid consumption (mg morphine equivalents)
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Pain Score
Tidsramme: Pain Burden at 24hrs
|
Numeric Rating Scale (NRS) (NRS pain scores; 0 = no pain,10 = excruciating pain) in the back of the knee recorded every 4 hours up to 24hrs following surgery.
Pain Bruden scale ranges from 0 (no pain) to 240 (extreme pain).
For example, pain burden of 120 is equivalent to a NRS score of 5 out of 10.
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Pain Burden at 24hrs
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Patient Satisfaction
Tidsramme: 24hr
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Patient satisfaction with pain control scale ranges from 0 (no satisfaction) to 10 (very satisfied).
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24hr
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Quality of Recovery (QoR15)
Tidsramme: 24hrs
|
Quality of recovery (QoR15) is a questionnaire that asks 15 questions regarding how the participant has felt in the last 24 hours.
Each question is followed by an 11-point numerical rating scale (0 = "none of the time" to 10 = "all of the time"; maximum score 150).
The higher the QoR15 total score, the worse the quality of recovery reported.
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24hrs
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Rohit Rahangdale, M.D., Northwestern University Feinberg School of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STU00085894
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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