Pain, Postoperative
Conditions
Keywords
Otolaryngology, Rhinoplasty, Bupivacaine, Liposomal Bupivacaine
Brief summary
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.
Detailed description
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.
Interventions
Volume: 4 mL of 0.75% bupivacaine hydrochloride
DRUGLiposomal Bupivacaine
Volume: 1.5 mL of 0.75% bupivacaine hydrochloride and 2.5 mL of liposomal bupivacaine
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
single-blinded
Intervention model description
This study is a single-site, prospective, randomized, single-blinded clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative opioid consumption | First 72 hours postoperatively | Cumulative opioid consumption in the first 72 post-operative hours expressed in morphine milligram equivalents (MME). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Brief Pain Inventory - Pain Outcomes | Postoperative day 0 through postoperative day 7 | 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. |
| Modified Brief Pain Inventory - Pain relief from analgesic medication | Postoperative day 0 through postoperative day 7 | 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). |
| Nausea | Postoperative day 0 through postoperative day 7 | 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. |
| Vomiting | Postoperative day 0 through postoperative day 7 | Incidence of vomiting, an opioid-related symptom assessed via daily postoperative patient self-report surveys. |
| Constipation | Postoperative day 0 through postoperative day 7 | Incidence of constipation, an opioid-related symptom assessed via daily postoperative patient self-report surveys. |
| Rash | Postoperative day 0 through postoperative day 7 | Incidence of rash, an opioid-related symptom assessed via daily postoperative patient self-report surveys. |
| Adherence to ERAS Multimodal Analgesic Regimen | Postoperative day 0 through postoperative day 7 | 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%. |
| Block site safety | Preoperative baseline and one month postoperatively | 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. |
| Adverse Events | Postoperative day 0 through one month postoperatively | Capturing any adverse events classified according to prespecified criteria described in the protocol. |
| Standardized Cosmesis and Health Nasal Outcomes Survey - Obstruction | Preoperative baseline and one month postoperatively | 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. |
| Standardized Cosmesis and Health Nasal Outcomes Survey - Cosmesis | Preoperative baseline and one month postoperatively | 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. |
Countries
United States
Contacts
CONTACTMatthew Wu, MD
CONTACTSara Kukuljan, BS, RN
PRINCIPAL_INVESTIGATORMatthew Wu, MD
Washington University School of Medicine
Outcome results
None listed