Bupivacaine for Postoperative Pain

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: United States Naval Medical Center, Portsmouth

Must not be taking: Mental health medications, opiates

Disqualifiers: Alcohol abuse, Revision surgery, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Tokunbo I Ayeni, MD

Principal Investigator

United States Naval Medical Center, Portsmouth

Eligibility Criteria

This trial is for patients undergoing their first septorhinoplasty at NMCP or Langley Air Force Base. It's not suitable for individuals with a history of alcohol abuse, opiate use disorder, mental health medication use, or those needing revision surgery.

Inclusion Criteria

I am getting a septorhinoplasty at NMCP or Langley Air Force Base.

Exclusion Criteria

History of alcohol abuse/dependence

History of opiate use disorder

I have taken medication for mental health.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a regional block with Exparel or injectable saline to the nose during septorhinoplasty

1 day

1 visit (in-person)

Follow-up

Participants are monitored for opiate use and pain intensity after surgery

1 week

1 visit (in-person), daily pain scale recording

Treatment Details

Interventions

• Bupivacaine

Trial Overview The study tests if using Bupivacaine (a local anesthetic) during surgery reduces the need for strong painkillers after the operation compared to a saline placebo.

Participant Groups

Group I: Exparel Experimental Treatment 1 Intervention

Application of regional block to the nose with Exparel

Group II: Saline Placebo Group 1 Intervention

Application of injectable saline to the nose

Who Is Running the Clinical Trial?

United States Naval Medical Center, Portsmouth

Lead Sponsor

Trials

35

Recruited

4,900+