Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia
ConditionPain, Postoperative
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
The purpose of this study is to find out which pain medication is more effective in reducing pain after nose surgery (rhinoplasty). The investigators are looking to find the best treatment to reduce discomfort and improve the healing process for patients having nose surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥18 years) undergoing open rhinoplasty of any indication or complexity (e.g., primary, revision, functional, or cosmetic), including autologous grafting of any type (e.g., septal or costal cartilage) or cadaveric grafting.
Disqualifiers
Chronic pain condition requiring ongoing or scheduled analgesic therapy, or any diagnosis associated with chronic pain (e.g., fibromyalgia, chronic headache/migraine, neuropathic pain, complex regional pain syndrome), long-term opioid use (≥3 months, any agent), allergy or contraindication to local anesthetics, acetaminophen, ibuprofen / NSAIDs, tramadol, ketamine, Medrol (methylprednisolone) dose pack
Concurrent non-nasal surgery planned
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Bupivacaine
DrugVolume: 4 mL of 0.75% bupivacaine hydrochloride
Liposomal Bupivacaine
DrugVolume: 1.5 mL of 0.75% bupivacaine hydrochloride and 2.5 mL of liposomal bupivacaine
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: Liposomal BupivacaineExperimental treatment 1 intervention
Group B: Standard BupivacaineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative opioid consumption
Cumulative opioid consumption in the first 72 post-operative hours expressed in morphine milligram equivalents (MME).
Time frame
First 72 hours postoperativelySecondary outcomes
1
Modified Brief Pain Inventory - Pain Outcomes
Patient-reported pain intensity and pain interference measured using the Modified Brief Pain Inventory (mBPI). Pain intensity is assessed with 3 items (average, current, and worst pain over the last 24 hours) and pain interference with 3 items (general activity, mood, and sleep). Each item is rated on a 0 to 10 numeric rating scale (0 = no pain / does not interfere; 10 = worst pain imaginable / completely interferes). Higher scores indicate a worse outcome.
Time frame
Postoperative day 0 through postoperative day 72
Modified Brief Pain Inventory - Pain relief from analgesic medication
Patient-reported relief from pain medication, measured using the corresponding item of the Modified Brief Pain Inventory (mBPI). The item is rated on a 0 to 10 numeric rating scale (0 = no relief; 10 = complete relief). Higher scores indicate a better outcome (greater pain relief).
Time frame
Postoperative day 0 through postoperative day 73
Nausea
Incidence of nausea, an opioid-related symptom, defined as the percentage of participants reporting any nausea on daily postoperative self-report surveys. Nausea is captured on a 0 to 10 rating and dichotomized as present (score ≥ 1) or absent (score 0) for this outcome. Reported as the percentage of participants (0% to 100%); a higher percentage indicates a worse outcome.
Time frame
Postoperative day 0 through postoperative day 74
Vomiting
Incidence of vomiting, an opioid-related symptom assessed via daily postoperative patient self-report surveys.
Time frame
Postoperative day 0 through postoperative day 7Sponsors and contacts
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Source ClinicalTrials.gov