Efficacy of Liposomal Bupivacaine Post Septorhinoplasty

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Jessyka Lighthall
Study ID
NCT05964868
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Pain Management
  • Rhinoplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Liposomal Bupivacaine — DRUG
    Patients will receive post-operative liposomal bupivacaine (EXPAREL®) at the surgical site at the completion of their septorhinoplasty.
  • 0.25% bupivacaine with 1:200,000 epinephrine — DRUG
    Non-liposomal encapsulated bupivacaine at the surgical site at the completion of septorhinoplasty.
  • Placebo - Saline solution — OTHER
    This group will receive a one-time 5 mL injection of saline post-operatively at the surgical site.

Study Details

The objective of this study is to determine if there is a difference in post-operative pain after septorhinoplasty when long-acting liposomal bupivacaine is used for local anesthesia compared to other standard local anesthetic regimens.

Key Dates

Start date
Feb 5, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liposomal Bupivacaine
    This group will receive a one time 5 mL injection of liposomal bupivacaine post-operatively at the surgical site.
  • Active Comparator: Bupivacaine with epinephrine
    This group will receive a one-time 5 mL injection of 0.25% bupivacaine with 1:200,000 epinephrine post-operatively at the surgical site.
  • Placebo Comparator: Saline solution
    This group will receive a one-time 5 mL injection of saline post-operatively at the surgical site.

Primary Outcome Measure

Differences in postoperative milligram morphine equivalents (MME) used between placebo and liposomal bupivacaine [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Jessyka LighthallHersheyPennsylvania17033-

Find similar trials in Hershey, PA

By research site
Jessyka Lighthall· Hershey, PA

Related Studies