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.
The investigators are comparing two types of pain relief medications: Liposomal Bupivacaine and Standard Bupivacaine. Participants who are undergoing rhinoplasty will be randomly assigned to receive either Liposomal Bupivacaine or Standard Bupivacaine during their surgery. Both medications are given as nerve blocks, which means they are injected near nerves to block pain signals. After the surgery, participants will be asked to rate their pain levels over several days. The investigators will also monitor any side effects and how quickly participants recover from the surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
Volume: 4 mL of 0.75% bupivacaine hydrochloride
Volume: 1.5 mL of 0.75% bupivacaine hydrochloride and 2.5 mL of liposomal bupivacaine
Washington University
St Louis, Missouri, United States
RECRUITINGCumulative opioid consumption
Cumulative opioid consumption in the first 72 post-operative hours expressed in morphine milligram equivalents (MME).
Time frame: First 72 hours postoperatively
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 7
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 7
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 7
Vomiting
Incidence of vomiting, an opioid-related symptom assessed via daily postoperative patient self-report surveys.
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Time frame: Postoperative day 0 through postoperative day 7
Constipation
Incidence of constipation, an opioid-related symptom assessed via daily postoperative patient self-report surveys.
Time frame: Postoperative day 0 through postoperative day 7
Rash
Incidence of rash, an opioid-related symptom assessed via daily postoperative patient self-report surveys.
Time frame: Postoperative day 0 through postoperative day 7
Adherence to ERAS Multimodal Analgesic Regimen
Patient adherence to the Enhanced Recovery After Surgery (ERAS) multimodal analgesic regimen, assessed using daily postoperative surveys, calculated as total number of pills taken / total number of pills prescribed x 100, with adherence defined as ≥80%.
Time frame: Postoperative day 0 through postoperative day 7
Block site safety
Proportion of participants with ≥1 new-onset injection-site or sensory adverse event, assessed by a 10-item binary patient-reported questionnaire at the supraorbital and infraorbital block sites. New-onset defined as negative at baseline and positive at follow-up.
Time frame: Preoperative baseline and one month postoperatively
Adverse Events
Capturing any adverse events classified according to prespecified criteria described in the protocol.
Time frame: Postoperative day 0 through one month postoperatively
Standardized Cosmesis and Health Nasal Outcomes Survey - Obstruction
Patient-reported nasal obstruction measured using the obstruction domain of the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS-O). The obstruction domain score is normalized to a 0 to 100 scale, where higher scores indicate a worse outcome (greater nasal obstruction). Scores obtained preoperatively and at one month postoperatively will be compared to assess short-term postoperative changes.
Time frame: Preoperative baseline and one month postoperatively
Standardized Cosmesis and Health Nasal Outcomes Survey - Cosmesis
Patient-reported cosmesis measured using the cosmesis domain of the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS-C). The cosmesis domain score is normalized to a 0 to 100 scale, where higher scores indicate a worse outcome (greater dissatisfaction with nasal appearance). Scores obtained preoperatively and at one month postoperatively will be compared to assess short-term postoperative changes.
Time frame: Preoperative baseline and one month postoperatively