Single Shot Exparel versus katheters bij trauma aan de onderste ledematen
Single-Shot Exparel versus katheters voor orthopedische traumapatiënten aan de onderste ledematen
This study will compare the use of single-shot Exparel, a long-acting local anesthestic, with the use of catheters that deliver a continuous flow of the short-acting local anesthetic ropivacaine. The comparison will be done in patients who receive preoperative adductor and sciatic nerve blocks prior to orthopedic surgery for traumatic lower extremity injury. The patients' pain will then be monitored for up to 72 hours after injection, measuring every 12 hours after injection until the 72-hour mark. Opioid consumption (measured in morphine milligram equivalents) will also be tracked over this time period.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
The use of Exparel has been widely criticized over the past few years with regard to its efficacy compared to perineural catheters and whether or not it truly lasts 72 hours, as is often advertised. However, it is still used in many centers for the proposed increased duration of action and ease of use compared to indwelling catheters, which require a greater degree of monitoring and follow-up for removal. Various studies conducted have looked at the efficacy of Exparel and have found no superiority over nerve blocks with other local anesthetic agents. However, nerve blocks with catheters have never been directly compared to exparel injections for pain control. As such, the goal of this study is to elucidate whether there truly is a difference between the two. In this study, the study team will compare preoperative adductor and sciatic nerve blocks with exparel versus catheters in orthopedic surgery patients who present with a traumatic lower extremity injury. Exparel has been documented to increase the duration of a nerve block by up to 72 hours. Studies comparing exparel single shot versus bupivacaine single shot have favored for the latter, which pharmacodynamically makes sense. A liposomal compound which slowly denatures to present an active component would seemingly be unlikely to match up against the higher concentration of said active component flood the desired site of action. In our study, the study team plans to measure the duration of the block with the addition of exparel in comparison to the duration of the block with a catheter which is connected to a pump continuously infusing a set rate of local anesthetics. Our primary research question is whether there is a statistically significant difference in pain control for 72 hours post-op in lower extremity orthopedic trauma when using Exparel versus a short-acting local anesthetic supplied via continuous infusion, in this case ropivacaine.
Studietype
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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District of Columbia
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Washington D.C., District of Columbia, Verenigde Staten, 20037
- The George Washington University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Closed lower extremity orthopedic injury
- Opioid naive patients
- No other significant surgical injuries on admission as determined by study physician
Exclusion Criteria:
- Allergy to local anesthetics
- Multiple traumatic injuries
- Weight less than 60 kg
- Prior opioid use or risk of increased pain control needs as determined by PI
- Chronic opioid use
- Open fractures
- Plastic surgery needed for complete closure
- Patient has intraoperative cardiac arrest
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Bupivacaine
|
Patients will receive the ERAS standard of care which includes gabapentin, Tylenol, and Toradol or Celebrex preoperatively as well as 20 cc of 0.25% bupivacaine with 10 cc of Exparel injected in the adductor space followed by 30 cc of 0.25% bupivacaine with 10 cc of Exparel in the sciatic nerve block. Injections will be completed by an anesthesia provider using astandard aseptic technique with ultrasound guidance. A 22 gauge 5-10cm needle is inserted with direct visualization under ultrasound and 2-5 cc aliquots are injected with aspiration repeated to ensure no vascular injury or injection until a total of 30 cc is injected into the adductor space and 40 cc is injected into the area surrounding the sciatic nerve. Exparel in this situation is being used off-label given that it is not FDA-approved for lower extremity nerve blocks. However, Exparel is commonly used in other nerve blocks and is FDA-approved for blocks such as the interscalene brachial plexus block. |
|
Experimenteel: Exparel + Bupivacaïne
|
Patients will receive the ERAS standard of care which includes gabapentin, Tylenol, and Toradol or Celebrex preoperatively as well as 20 cc of 0.25% bupivacaine injected in the adductor space followed by 30 cc of 0.25% bupivacaine in the sciatic nerve block. Injections will be completed by an anesthesia provider in the same manner as above. Catheters will be left in both spaces with post-operative pumps running 0.2% ropivacaine at 8 cc/hr. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Postoperative Pain Score
Tijdsspanne: 12 hours
|
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain) |
12 hours
|
|
Postoperative Pain Score
Tijdsspanne: 24 hours
|
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain) |
24 hours
|
|
Postoperative Pain Score
Tijdsspanne: 36 hours
|
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain) |
36 hours
|
|
Postoperative Pain Score
Tijdsspanne: 48 hours
|
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain) |
48 hours
|
|
Postoperative Pain Score
Tijdsspanne: 60 hours
|
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain) |
60 hours
|
|
Postoperative Pain Score
Tijdsspanne: 72 hours
|
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain) |
72 hours
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Morphine equivalents
Tijdsspanne: Day 1
|
Morphine equivalents at 24 hours postoperatively |
Day 1
|
|
Morphine equivalents
Tijdsspanne: Day 2
|
Morphine equivalents at 24-48 hours postoperatively |
Day 2
|
|
Morphine equivalents
Tijdsspanne: Day 3
|
Morphine equivalents at 48-72 hours postoperatively |
Day 3
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NCR256547
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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