- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19107
- Thomas Jefferson University Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- speaks English
Exclusion Criteria:
- children,
- neuropathy in operative arm
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: In-plane group
This group will receive an interscalene catheter placed with in-plane approach.
|
Andra namn:
|
|
Experimentell: Out-of-plane group
This group will receive an interscalene catheter with an out-of-plan approach.
|
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Visual Analog Scale Pain Scores
Tidsram: 24 hours
|
Pain was rated from 0 (no pain) to 10 (worst pain imaginable)
|
24 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Catheter Dislodgements
Tidsram: 24 hours
|
Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not.
|
24 hours
|
|
Opioid Consumption
Tidsram: 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
|
48 hours
|
|
Time for Block Placement
Tidsram: immediately post-procedure
|
Calculate the time to perform the nerve block procedure.
|
immediately post-procedure
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 12D.328
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