Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
75 participants
INTERVENTIONAL
2026-01-31
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ESP + Liposomal Bupivacaine
Group 1 receives ESP block with 0.5% bupivacaine plus liposomal bupivacaine.
ESP Block with Bupivacaine + Liposomal Bupivacaine
Cervical and lumbar ESP blocks performed under ultrasound guidance using bupivacaine admixed with liposomal bupivacaine.
ESP + Plain Bupivacaine
Group 2 receives ESP block with 0.5% plain bupivacaine.
ESP Block with Bupivacaine
Cervical and lumbar ESP blocks performed under ultrasound guidance using plain bupivacaine.
Interventions
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ESP Block with Bupivacaine + Liposomal Bupivacaine
Cervical and lumbar ESP blocks performed under ultrasound guidance using bupivacaine admixed with liposomal bupivacaine.
ESP Block with Bupivacaine
Cervical and lumbar ESP blocks performed under ultrasound guidance using plain bupivacaine.
Eligibility Criteria
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Inclusion Criteria
* Age 18-75
* ASA physical status 1-3
* Undergoing elective cervical or lumbar posterior spinal fusion (≤3 levels)
Exclusion Criteria
* ASA IV or V
* Non-English speaking
* BMI \>40
* Opioid dependence
* Chronic pain
* Anticoagulation or coagulopathy
* Injection site infection
* Hepatic or renal insufficiency
* Allergy to study drugs
* Pregnancy
* Inability to communicate with investigators
18 Years
75 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Stephen Davies
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00118950
Identifier Type: -
Identifier Source: org_study_id
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