- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01696188
A Study Comparing Two Methods of Placing an Interscalene Nerve Catheter for Postoperative Pain Control in Patients Who Undergo Open Shoulder Surgery.
Comparison of In-Plane vs. Out-of-Plane Ultrasound-Guided Approach for Interscalene Nerve Catheters: a Prospective, Randomized Trial
Studieoversikt
Detaljert beskrivelse
Interscalene nerve block is an effective method of analgesia for surgery of the upper extremity. Perineural interscalene catheters offer the advantage of extended pain relief up to 48 hours after shoulder surgery. This is a prospective, randomized trial designed to compare two approaches (posterior and anterolateral) to interscalene continuous nerve catheter placement for analgesia after open shoulder surgery (open rotator cuff repair, total shoulder arthroplasty or revision, hemi-arthroplasty, or proximal humerus open reduction internal fixation). Specifically, the objectives of this study are to compare measured pain scores, opioid consumption, and catheter dislodgements. We hypothesize that the anterolateral approach will produce lower pain scores, less opioid consumption, and fewer catheter dislodgements.
All patients undergoing open shoulder surgery will be recruited and enrollment in the study will not deviate from the current standard of care at Thomas Jefferson University Hospital. All nerve blocks will be placed by a regional anesthesiologist or a fellow in regional anesthesia. Patient medical history will be obtained and blocks will be placed per usual protocol. Block efficacy will be assessed by physical exam immediately after placement by the anesthesiologist and another member of the research team. Operative details, including medications given, will be recorded.
Patient pain scores and medications given in the PACU will be recorded. Supplementary analgesics will be available. Pain scores, medications given, and sensory examinations will be recorded for 48 hours postoperatively. Data will be analyzed both at the conclusion of the study and at several interims before that.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
- Thomas Jefferson University Hospital
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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:
- speaks English
Exclusion Criteria:
- children,
- neuropathy in operative arm
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: In-plane group
This group will receive an interscalene catheter placed with in-plane approach.
|
Andre navn:
|
|
Eksperimentell: Out-of-plane group
This group will receive an interscalene catheter with an out-of-plan approach.
|
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual Analog Scale Pain Scores
Tidsramme: 24 hours
|
Pain was rated from 0 (no pain) to 10 (worst pain imaginable)
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Catheter Dislodgements
Tidsramme: 24 hours
|
Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not.
|
24 hours
|
|
Opioid Consumption
Tidsramme: 48 hours
|
Calculate the total amount of opioid consumed in the first 48 hours after surgery using a standard opioid conversion scale. 1 mg hydrocodone = 0.33 mg IV morphine, 1 mg oxycodone = 0.50 mg morphine IV, 1 mg hydromorphone PO = 1.33 mg morphine IV, 1 mcg fentanyl = 0.1 mg morphine IV, 1 mg hydromorphone IV = 6.67 mg morphine IV
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48 hours
|
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Time for Block Placement
Tidsramme: immediately post-procedure
|
Calculate the time to perform the nerve block procedure.
|
immediately post-procedure
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Fredrickson MJ, Ball CM, Dalgleish AJ. Posterior versus anterolateral approach interscalene catheter placement: a prospective randomized trial. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):125-33. doi: 10.1097/aap.0b013e31820d5ee6.
- Antonakakis JG, Sites BD, Shiffrin J. Ultrasound-guided posterior approach for the placement of a continuous interscalene catheter. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):64-8. doi: 10.1016/AAP.0b013e3181933a53.
- Mariano ER, Loland VJ, Ilfeld BM. Interscalene perineural catheter placement using an ultrasound-guided posterior approach. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):60-3. doi: 10.1097/AAP.0b013e3181933af7.
Studierekorddatoer
Studer hoveddatoer
Studiestart
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 (Anslag)
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
- 12D.328
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