Parasternal Nerve Block in Cardiac Patients
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|ClinicalTrials.gov Identifier: NCT01826851|
Recruitment Status : Completed
First Posted : April 9, 2013
Results First Posted : August 1, 2018
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Pain, Postoperative||Drug: Exparel Drug: Placebo||Phase 2|
This is a Phase 2, single-institution, randomized, double-blind, parallel-group, placebo-controlled trial of patients undergoing a median sternotomy for primary cardiopulmonary bypass grafting (CABG) surgery.
78 subjects (39 per treatment arm) will be randomized in a 1:1 ratio to receive a single-dose, parasternal nerve block with either 266 mg Exparel or placebo (0.9% normal saline solution). The nerve blocks will be performed under direct visualization at the end of surgery, just prior to sternal closure.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||79 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Parasternal Intercostal Nerve Block in Post-Cardiac Surgery Patients: A Randomized, Controlled Trial of Extended-release Liposomal Bupivacaine (Exparel) Versus Placebo|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
266 mg Exparel, single-dose injection.
Patients in this group will receive 266 mg Exparel diluted with 0.9% normal saline to a total volume of 50 mL and administered via parasternal intercostal nerve block prior to sternal closure.
Post-operatively, patients will receive IV fentanyl as needed in the ICU while still intubated. A fentanyl PCA pump will be set up post-extubation as soon as possible and prior to the patient leaving the ICU.
Placebo Comparator: Placebo
0.9% Normal saline, single-dose injection.
Patients in this group will receive 50 mL of 0.9% normal saline as a parasternal intercostal nerve block prior to sternal closure.
Post-surgical pain management will be the same as for the Exparel group.
Other Name: Preservative-free normal saline
- Median Cumulative Morphine Equivalent [ Time Frame: Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block. ]The cumulative opioid requirement is reported as morphine equivalent. The total amount of narcotics required by the subjects in the Exparel group and placebo group were measured at 1,2,4,8,12,24,36,48,60, and 72 hours post-injection of Exparel or 0.9% normal saline. The amounts were analyzed and are reported as morphine equivalents.
- Median Pain Levels [ Time Frame: Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block. ]The pain scores of the subjects in the Exparel group and placebo group were measured at 1,2,4,8,12,24,36,48,60, and 72 hours post-injection of Exparel or 0.9% normal saline. The pain scores were reported on a scale of 0 - 10. 0 being no pain. 10 being the worst pain.
- Time to Extubation (Hours) [ Time Frame: 77 hours ]Time to remove endotracheal tube following surgery.
- ICU Length of Stay (Hours) [ Time Frame: 135 hours ]Duration of time spent in the intensive care unit postoperatively.
- Time to First Bowel Movement (Days) [ Time Frame: 35 days ]Time to first bowel movement following surgery.
- Hospital Length of Stay (Days) [ Time Frame: 25 days ]Duration of time spent in the hospital following surgery.
- Time to Return to Work or Daily Activities [ Time Frame: 36 days ]Time to return to work or daily activities following surgery will be assessed at postoperative clinic follow up or during a follow up telephone interview.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826851
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Peter A Knight, MD||University of Rochester|