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Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy

NCT04585867 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-10-14

No results posted yet for this study

Summary

Researchers hope to learn whether giving the longer-acting local anesthetic liposomal bupivacaine prior to closing the sternum is more effective in managing pain following sternotomy, than in patients who received standard bupivacaine before sternal closure. Researchers will measure this based on how much IV pain medication is used, rates on confusion, and time to remove the breathing tube.

Conditions

  • Pain Management
  • Sternotomy

Interventions

DRUG

Exparel

The injections will be performed under direct guidance by the cardiac surgeon at bilateral sternal-costal interspaces 1.5 cm lateral the sternal boarder at levels 2-6 in divided doses (2 ml/injection) just before the closure of the sternum near the end of the surgical procedure. The final 20 ml will be injected into the skin incision after closure

DRUG

Bupivacaine

The injections will be performed under direct guidance by the cardiac surgeon at bilateral sternal-costal interspaces 1.5 cm lateral the sternal boarder at levels 2-6 in divided doses (2 ml/injection) just before the closure of the sternum near the end of the surgical procedure. The final 20 ml will be injected into the skin incision after closure

Sponsors & Collaborators

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Jared Staab, DO · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-11
Primary Completion
2023-10-10
Completion
2023-10-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04585867 on ClinicalTrials.gov