A Phase 4 interventional study of Continuous Sternal Block and Opioid based analgesia in Surgery, Pneumonia and Surgical Site Infection, sponsored by Halyard Health. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-19.
Sponsored by Halyard Health · Phase 4, Interventional, and Treatment
The main goals of the study are as follows: (1) to determine the correlation between pain management using continuous infusion of local anesthetics and the incidence of pneumonia and surgical infection in cardiac surgery patients; and (2) to evaluate the relationship between hospital-acquired pneumonia and surgical infection and patient outcomes, including length of hospital stay.
Nosocomial infections are recognized as an important cause of increased patient morbidity and mortality. The reported prevalence for nosocomial infections most commonly ranges from 5 to 20%, but can be significantly greater among patients requiring intensive care. The most common sites of hospital acquired infection include the lung, urinary tract, surgical wounds, and the bloodstream. Patients undergoing cardiac surgery appear to be at increased risk for the development of nosocomial infections due to the presence of multiple surgical wounds (chest and lower extremity incisions), frequent postoperative utilization of invasive devices (i.e. central venous catheters, chest drains, intra-aortic balloon counter pulsation, pulmonary artery catheter), and the common use of prophylactic or empiric antibiotics in the perioperative period. In the cardiac surgical postoperative period, nosocomial infections have been found to be associated with prolonged length of stay (LOS) in the ICU and total hospitalization, development of multiorgan dysfunction, and increased hospital mortality. Nosocomial Pneumonia (NP) is in fact the leading cause of mortality due to hospital-acquired infections. Patients with Ventilator Associated Pneumonia (VAP) have been found in various studies to have significantly higher mortality rates than those without VAP, with ranges of 20.2-45.5% and 8.5-32.2%, respectively. Strategies that both reduce postoperative pain and sedation have the potential to reduce postoperative pneumonia by allowing earlier extubation and more effective pulmonary toilet post-extubation. Non-opioid pain management has the potential to reduce NP rates because of superior pain management, as well as the reduction in opioids required, and the concomitant avoidance of opioid side effects. The clinical and financial consequences of NP justify aggressively pursuing strategies aimed at prevention. Specifically, these strategies are targeted at reducing the incidence of NP by addressing the modifiable risk factors including prolonged endotracheal intubation and ventilator support, sedation, and long hospital LOS.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 647 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Halyard Health is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system
Device: Continuous Sternal Block
Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics
Drug: Opioid based analgesia
Elastomeric Pump for Continuous Infusion of Local Anesthetic
Also known as: ON-Q, PainBuster
Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN
Also known as: PCA
Hospital Acquired Pneumonia
Pneumonia diagnosed during hospitalization
Time frame: 30 days postoperative
Surgical Site Infection
surgical site infection diagnosed within 30 days post surgery
Time frame: 30 days postoperative
Hospital Length of Stay
time (days) from date of admission to discharge
Time frame: primary admission
| Milestone | Continuous Sternal Block | Opioid Based Analgesia |
|---|---|---|
| Started | 321 | 326 |
| Completed | 321 | 326 |
| Not completed | 0 | 0 |
Pneumonia diagnosed during hospitalization
| participants | Continuous Sternal Block | Opioid Based Analgesia |
|---|---|---|
| Hospital Acquired Pneumonia | 8 | 18 |
surgical site infection diagnosed within 30 days post surgery
| participants | Continuous Sternal Block | Opioid Based Analgesia |
|---|---|---|
| Surgical Site Infection | 17 | 19 |
time (days) from date of admission to discharge
| days | Continuous Sternal Block | Opioid Based Analgesia |
|---|---|---|
| Hospital Length of Stay | 8.8 ± 29.9 | 9.5 ± 29.6 |
Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Continuous Sternal Block | — | 0/321 (0%) | 0/321 (0%) |
| Opioid Based Analgesia | — | 0/326 (0%) | 0/326 (0%) |
| Age, Continuous(years) | Continuous Sternal Block | Opioid Based Analgesia | Total |
|---|---|---|---|
| Mean | 64.3 ± 12.1 | 65.2 ± 11.5 | 64.7 ± 11.8 |
| Sex: Female, Male(Participants) | Continuous Sternal Block | Opioid Based Analgesia | Total |
|---|---|---|---|
| Female | 101 | 97 | 198 |
| Male | 220 | 229 | 449 |
| Race (NIH/OMB)(Participants) | Continuous Sternal Block | Opioid Based Analgesia | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 4 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 29 | 26 | 55 |
| White | 273 | 277 | 550 |
| More than one race | 6 | 12 | 18 |
| Unknown or Not Reported | 9 | 7 | 16 |
| Region of Enrollment(participants) | Continuous Sternal Block | Opioid Based Analgesia | Total |
|---|---|---|---|
| United States | 321 | 326 | 647 |
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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