NCT06989866

Brief Summary

Examining use of strong pain medication with the use of perioperative anesthetic medications vs no use of the same perioperative medication

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3 postoperative-pain

Timeline
4mo left

Started Dec 2024

Typical duration for phase_3 postoperative-pain

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Dec 2024Sep 2026

Study Start

First participant enrolled

December 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

October 9, 2025

Status Verified

October 1, 2025

Enrollment Period

1.7 years

First QC Date

April 10, 2025

Last Update Submit

October 7, 2025

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Use of Opiate Pain Medications After Rhinoplasty

    How many opiate pills are used after rhinoplasty

    1 week

Secondary Outcomes (1)

  • PROMIS - Pain Intensity Questionnaire

    1 week

Study Arms (2)

Exparel

EXPERIMENTAL

Application of regional block to the nose with Exparel

Drug: Bupivacaine

Saline

PLACEBO COMPARATOR

Application of injectable saline to the nose

Drug: Saline (NaCl 0,9 %) (placebo)

Interventions

BupivacaineDRUG

Bupivicaine injection post operatively

Exparel
Saline (NaCl 0,9 %) (placebo)DRUG

Saline injected to control group

Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving a primary septorhinplasty at NMCP or Langley Air Force Base

You may not qualify if:

  • History of alcohol abuse/dependence, mental health medications or opiate use disorder. Revision surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Tokunbo I Ayeni, MD

    United States Naval Medical Center, Portsmouth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2025

First Posted

May 25, 2025

Study Start

December 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

October 9, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)