Recruiting
Phase 1

Liposomal Bupivacaine vs Bupivacaine

Sponsor:

University of Kansas Medical Center

Code:

NCT04585867

Conditions

Pain Management

Sternotomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exparel

Bupivacaine

Study Details

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.

Conditions

Pain Management

Sternotomy

Study ID

NCT04585867

Start date

Oct 11, 2017

Status verified date

Oct, 2020

Completion date

Oct 10, 2023

Anticipated

Primary completion date

Oct 10, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Liposomal bupivacaine

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

active comparator: Bupivacaine

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

Interventions

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

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

Primary outcome measure

  • Opioid consumption in morphine equivalents [ Time Frame: 0 hours post-surgery ]
  • Opioid consumption in morphine equivalents [ Time Frame: 12 hours post-surgery ]
  • Opioid consumption in morphine equivalents [ Time Frame: 24 hours post-surgery ]
  • Opioid consumption in morphine equivalents [ Time Frame: 36 hours post-surgery ]
  • Opioid consumption in morphine equivalents [ Time Frame: 48 hours post-surgery ]
  • Opioid consumption in morphine equivalents [ Time Frame: 60 hours post-surgery ]
  • Opioid consumption in morphine equivalents [ Time Frame: 72 hours post-surgery ]

Central Contacts and Locations

Central contacts

Angie Ballew, DC, MS

9139457420aballew@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Abigail Houchin

ahouchin@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Oct 14, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2020-10-14.