Trial Outcomes & Findings for Effectiveness of an Opioid Sparing Pain Regimen in Cardiac Surgery (NCT NCT03679013)
NCT ID: NCT03679013
Last Updated: 2022-11-08
Results Overview
Number of patients with requests for breakthrough pain medication. Requests for breakthrough pain medication is defined as having pain scores \>4 using the Numeric Rating Scale: a dimensional measurement of pain intensity; 0-10 scale for scoring pain (0= "no pain", 10"worst pain imaginable")
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
24 hours, 48 hours, 72 hours after post-surgical treatment
Results posted on
2022-11-08
Participant Flow
Participant milestones
| Measure |
Opioid Based Standard of Care Regimen.
Inova Heart and Vascular Institute (IHVI) opioid based standard of care regimen given for post operative cardiac surgery pain.
Opiate based pain regimen.: Standard of care opiate based pain regimen.
|
Opioid Sparing Pain Regimen.
Multimodal pain regimen consisting of PO Gabapentin paired with intravenous Acetaminophen given for post operative cardiac surgery pain.
Oral Gabapentin and Intravenous Acetaminophen (IV APAP): Scheduled multimodal pain regimen consisting of oral Gabapentin paired with intravenous Acetaminophen following cardiopulmonary bypass surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
11
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of an Opioid Sparing Pain Regimen in Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Opioid Based Standard of Care Regimen.
n=8 Participants
Inova Heart and Vascular Institute (IHVI) opioid based standard of care regimen given for post operative cardiac surgery pain.
Opiate based pain regimen.: Standard of care opiate based pain regimen.
|
Opioid Sparing Pain Regimen.
n=11 Participants
Multimodal pain regimen consisting of PO Gabapentin paired with intravenous Acetaminophen given for post operative cardiac surgery pain.
Oral Gabapentin and Intravenous Acetaminophen (IV APAP): Scheduled multimodal pain regimen consisting of oral Gabapentin paired with intravenous Acetaminophen following cardiopulmonary bypass surgery.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.1 years
n=5 Participants
|
65.5 years
n=7 Participants
|
66.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours, 48 hours, 72 hours after post-surgical treatmentNumber of patients with requests for breakthrough pain medication. Requests for breakthrough pain medication is defined as having pain scores \>4 using the Numeric Rating Scale: a dimensional measurement of pain intensity; 0-10 scale for scoring pain (0= "no pain", 10"worst pain imaginable")
Outcome measures
| Measure |
Opioid Based Standard of Care Regimen.
n=8 Participants
Inova Heart and Vascular Institute (IHVI) opioid based standard of care regimen given for post operative cardiac surgery pain.
Opiate based pain regimen.: Standard of care opiate based pain regimen.
|
Opioid Sparing Pain Regimen.
n=11 Participants
Multimodal pain regimen consisting of PO Gabapentin paired with intravenous Acetaminophen given for post operative cardiac surgery pain.
Oral Gabapentin and Intravenous Acetaminophen (IV APAP): Scheduled multimodal pain regimen consisting of oral Gabapentin paired with intravenous Acetaminophen following cardiopulmonary bypass surgery.
|
|---|---|---|
|
The Number of Patients With Requests for Breakthrough Opioid Pain Medication in Opioid Standard of Care Regimen Compared to Non-opioid Multimodal Pain Relief Regimen (Experimental Group).
24 hours
|
7 Participants
|
2 Participants
|
|
The Number of Patients With Requests for Breakthrough Opioid Pain Medication in Opioid Standard of Care Regimen Compared to Non-opioid Multimodal Pain Relief Regimen (Experimental Group).
48 hours
|
7 Participants
|
1 Participants
|
|
The Number of Patients With Requests for Breakthrough Opioid Pain Medication in Opioid Standard of Care Regimen Compared to Non-opioid Multimodal Pain Relief Regimen (Experimental Group).
72 hours
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: at 24, 48, and 72 hours after the start of post-operative treatmentParticipants were assessed by rating their pain according to the Numeric Rating Scale: a dimensional measurement of pain intensity; 0-10 scale for scoring pain (0= "no pain", 10="worst pain imaginable") The minimum and maximum pain scores per participant were aggregated at timepoints of 24 hours, 48 hours, and 72 hours after the start of post-operative treatment
Outcome measures
| Measure |
Opioid Based Standard of Care Regimen.
n=8 Participants
Inova Heart and Vascular Institute (IHVI) opioid based standard of care regimen given for post operative cardiac surgery pain.
Opiate based pain regimen.: Standard of care opiate based pain regimen.
|
Opioid Sparing Pain Regimen.
n=11 Participants
Multimodal pain regimen consisting of PO Gabapentin paired with intravenous Acetaminophen given for post operative cardiac surgery pain.
Oral Gabapentin and Intravenous Acetaminophen (IV APAP): Scheduled multimodal pain regimen consisting of oral Gabapentin paired with intravenous Acetaminophen following cardiopulmonary bypass surgery.
|
|---|---|---|
|
Average Pain Score at 24, 48 and 72 Hours Post-operatively
Minimum Pain Score at 24 hours
|
1 score on a scale
Interval 0.0 to 3.0
|
0.09 score on a scale
Interval 0.0 to 1.0
|
|
Average Pain Score at 24, 48 and 72 Hours Post-operatively
Maximum Pain Score at 24 hours
|
7 score on a scale
Interval 4.0 to 10.0
|
3.18 score on a scale
Interval 0.0 to 5.0
|
|
Average Pain Score at 24, 48 and 72 Hours Post-operatively
Minimum Pain Score at 48 hours
|
1 score on a scale
Interval 0.0 to 3.0
|
0.18 score on a scale
Interval 0.0 to 1.0
|
|
Average Pain Score at 24, 48 and 72 Hours Post-operatively
Maximum Pain Score at 48 hours
|
6.75 score on a scale
Interval 3.0 to 8.0
|
3.64 score on a scale
Interval 0.0 to 6.0
|
|
Average Pain Score at 24, 48 and 72 Hours Post-operatively
Minimum Pain Score at 72 hours
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Average Pain Score at 24, 48 and 72 Hours Post-operatively
Maximum Pain Score at 72 hours
|
2.5 score on a scale
Interval 0.0 to 5.0
|
2.36 score on a scale
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: Surgery completion through study completion up to one week.The number of participants with occurrences of ileus during hospitalization.
Outcome measures
| Measure |
Opioid Based Standard of Care Regimen.
n=8 Participants
Inova Heart and Vascular Institute (IHVI) opioid based standard of care regimen given for post operative cardiac surgery pain.
Opiate based pain regimen.: Standard of care opiate based pain regimen.
|
Opioid Sparing Pain Regimen.
n=11 Participants
Multimodal pain regimen consisting of PO Gabapentin paired with intravenous Acetaminophen given for post operative cardiac surgery pain.
Oral Gabapentin and Intravenous Acetaminophen (IV APAP): Scheduled multimodal pain regimen consisting of oral Gabapentin paired with intravenous Acetaminophen following cardiopulmonary bypass surgery.
|
|---|---|---|
|
Number of Participants With Ileus During Hospitalization
|
0 Participants
|
0 Participants
|
Adverse Events
Opioid Based Standard of Care Regimen.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Opioid Sparing Pain Regimen.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place