Health TrialsbyHealthPanel

Pain Control for Undergoing Costal Cartilage Harvesting

ConditionNasal Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

The purpose of this study is to find out whether injecting the U.S. Food and Drug Administration (FDA) approved drug EXPAREL®, a long acting (approximately 96 hours) numbing medication, will reduce pain after rib cartilage removal in comparison to the standard injection of XYLOCAINE®.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosis of functional nasal obstruction or aesthetic nasal concern requiring nasal surgery with costal cartilage harvest.

Willing and able to understand and provide written informed consent.

Disqualifiers

Known pregnancy.

Women who are currently nursing a child.

History of coagulopathy; such as hemophilia or Von Willebrand disease, or any congenital or acquired bleeding disorder.

Use of anticoagulation medication during the study, i.e. aspirin, Coumadin, Plavix, or medications similar in class to these medications will exclude the patient from participation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exparel

    Drug

    106mg (8 mL) subcutaneous injection injected after costal cartilage harvest

  • Xylocaine

    Drug

    8 mL of 1% lidocaine with 1:100,000 of epinephrine into costal cartilage wound site

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Exparel® Injection GroupExperimental treatment 1 intervention
Group B: Xylocaine® Injection GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Scores

Measured using a visual analog scale 0=no pain and 10=worst possible

Time frame
7-10 days following the last administration of study treatment
2

Change in oral pain medication

Total oral pain medication usage self-reported in pain medication diary

Time frame
7-10 days following the last administration of study treatment

Secondary outcomes

1

Adverse Reactions

Total number of adverse reactions reported to the study agent

Time frame
7-10 days following the last administration of study treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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