NCT04585867

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

October 11, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

6 years

First QC Date

September 24, 2020

Last Update Submit

October 12, 2020

Conditions

Pain ManagementSternotomy

Outcome Measures

Primary Outcomes (7)

  • Opioid consumption in morphine equivalents

    Opioid consumption in morphine equivalents

    0 hours post-surgery

  • Opioid consumption in morphine equivalents

    Opioid consumption in morphine equivalents

    12 hours post-surgery

  • Opioid consumption in morphine equivalents

    Opioid consumption in morphine equivalents

    24 hours post-surgery

  • Opioid consumption in morphine equivalents

    Opioid consumption in morphine equivalents

    36 hours post-surgery

  • Opioid consumption in morphine equivalents

    Opioid consumption in morphine equivalents

    48 hours post-surgery

  • Opioid consumption in morphine equivalents

    Opioid consumption in morphine equivalents

    60 hours post-surgery

  • Opioid consumption in morphine equivalents

    Opioid consumption in morphine equivalents

    72 hours post-surgery

Secondary Outcomes (3)

  • Time to extubation in minutes will be retrieved via the electronic medical record

    30 days post operative

  • Presence of sternal wound infection

    4-6 weeks postoperative visit

  • Postoperative delirium as assessed by Confusion Assessment Method (CAM)-ICU

    30 days post operative

Study Arms (2)

Liposomal bupivacaine

ACTIVE COMPARATOR

Exparel (266mg) given by surgeon just prior to sternal closure

Drug: Exparel

Bupivacaine

ACTIVE COMPARATOR

40ml of 0.125% bupivacaine given by surgeon just prior to sternal closure

Drug: Bupivacaine

Interventions

ExparelDRUG

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

Liposomal bupivacaine
BupivacaineDRUG

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

Bupivacaine

Eligibility Criteria

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

You may qualify if:

  • Adults over the age of 18 who present for elective open heart surgery that requires a sternotomy.

You may not qualify if:

  • Urgent and emergency procedures,
  • preexisting sternal infections,
  • prior sternotomy,
  • preexisting pain syndromes,
  • current chronic home opioid use,
  • anterior rib or sternal masses,
  • allergy to any of the components of liposomal bupivacaine and plain bupivacaine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jared Staab, DO

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Angie Ballew, DC, MS

CONTACT

9139457420aballew@kumc.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

September 24, 2020

First Posted

October 14, 2020

Study Start

October 11, 2017

Primary Completion

October 10, 2023

Study Completion

October 10, 2023

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

US(1)