Single Shot Exparel vs Catheters in Lower Extremity Trauma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeorge Washington University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Closed lower extremity orthopedic injury
Opioid naive patients
No other significant surgical injuries on admission as determined by study physician
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine
DrugPatients 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.
Exparel + Bupivacaine
DrugPatients 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Exparel + BupivacaineExperimental treatment 1 intervention
Group B: BupivacaineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Pain Score
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
Time frame
12 hours2
Postoperative Pain Score
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
Time frame
24 hours3
Postoperative Pain Score
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
Time frame
36 hours4
Postoperative Pain Score
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
Time frame
48 hoursSecondary outcomes
1
Morphine equivalents
Morphine equivalents at 24 hours postoperatively
Time frame
Day 12
Morphine equivalents
Morphine equivalents at 24-48 hours postoperatively
Time frame
Day 23
Morphine equivalents
Morphine equivalents at 48-72 hours postoperatively
Time frame
Day 3Sponsors and contacts
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Source ClinicalTrials.gov