Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia

Purpose

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.

Condition

  • Pain, Postoperative

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This study is a single-site, prospective, randomized, single-blinded clinical trial
Primary Purpose
Treatment
Masking
Single (Participant)
Masking Description
single-blinded

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Liposomal Bupivacaine
Participants randomized to the experimental arm will receive bilateral supraorbital and infraorbital nerve blocks using liposomal bupivacaine at the end of surgery.
  • Drug: Liposomal Bupivacaine
    Volume: 1.5 mL of 0.75% bupivacaine hydrochloride and 2.5 mL of liposomal bupivacaine
    Other names:
    • Exparel
Active Comparator
Standard Bupivacaine
The control arm will receive standard bupivacaine nerve blocks using the same injection sites and volumes appropriate for safe regional anesthesia
  • Drug: Standard Bupivacaine
    Volume: 4 mL of 0.75% bupivacaine hydrochloride
    Other names:
    • Marcaine

Recruiting Locations

Washington University
St Louis, Missouri 63110
Contact:
Sara Kukuljan, BS, RN
314-362-7563
kukuljas@wustl.edu

More Details

Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Matthew Wu, MD
314-362-0524
mjwu@wustl.edu

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.