Trial Outcomes & Findings for Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery (NCT NCT03682367)
NCT ID: NCT03682367
Last Updated: 2021-07-09
Results Overview
Determine the difference in average morphine equivalent units between experimental and control group.
TERMINATED
PHASE3
8 participants
Perioperative.
2021-07-09
Participant Flow
Participant milestones
| Measure |
Control
Standard of care use of perioperative analgesia with acetaminophen and opioids that is supplemented with placebo solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and placebo.
Placebo - Concentrate: Use of sugar-free Placebo peri- and post-operatively.
|
Intervention
Interventional use of perioperative analgesia with acetaminophen and opioids that is supplemented with gabapentin solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and gabapentin.
Gabapentin: Use of Gabapentin peri- and post-operatively.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Control
Standard of care use of perioperative analgesia with acetaminophen and opioids that is supplemented with placebo solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and placebo.
Placebo - Concentrate: Use of sugar-free Placebo peri- and post-operatively.
|
Intervention
Interventional use of perioperative analgesia with acetaminophen and opioids that is supplemented with gabapentin solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and gabapentin.
Gabapentin: Use of Gabapentin peri- and post-operatively.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Closed Study Early
|
0
|
3
|
Baseline Characteristics
Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery
Baseline characteristics by cohort
| Measure |
Control
n=4 Participants
Standard of care use of perioperative analgesia with acetaminophen and opioids that is supplemented with placebo solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and placebo.
Placebo - Concentrate: Use of sugar-free Placebo peri- and post-operatively.
|
Intervention
n=4 Participants
Interventional use of perioperative analgesia with acetaminophen and opioids that is supplemented with gabapentin solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and gabapentin.
Gabapentin: Use of Gabapentin peri- and post-operatively.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Perioperative.Population: Due to safety concerns and patient non-compliance, the data was unreliable and uninterpretable.
Determine the difference in average morphine equivalent units between experimental and control group.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 week post-operation.Population: Due to safety concerns and patient non-compliance, the data was unreliable and uninterpretable.
Determine the difference in average morphine equivalent units between experimental and control group.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 30 days post-operation.Population: Due to safety concerns and patient non-compliance, the data was unreliable and uninterpretable.
Determine the difference in average morphine equivalent units between experimental and control group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Perioperative, 1 week post-operation, 1 week post-discharge, and 30 days post-operation.Population: Due to safety concerns and patient non-compliance, the data was unreliable and uninterpretable.
Determine average change of inpatient Pain Score Visual Analog Scale (VAS) on a standardized 1 (no pain) to 10 (highest level of pain) scale between experimental and control groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days post-operation.Population: Due to safety concerns and patient non-compliance, the data was unreliable and uninterpretable.
Incidence of postoperative complications between experimental and control group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days post-operation.Population: Due to safety concerns and patient non-compliance, the data was unreliable and uninterpretable.
Incidence of narcotics-related complications between experimental and control group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week post-operation.Population: Due to safety concerns and patient non-compliance, the data was unreliable and uninterpretable.
Determine the difference of average inpatient length of stay between experimental and control group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week post-operation.Population: Due to safety concerns and patient non-compliance, the data was unreliable and uninterpretable.
Determine the difference of average inpatient cost between experimental and control group.
Outcome measures
Outcome data not reported
Adverse Events
Control
Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=4 participants at risk
Standard of care use of perioperative analgesia with acetaminophen and opioids that is supplemented with placebo solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and placebo.
Placebo - Concentrate: Use of sugar-free Placebo peri- and post-operatively.
|
Intervention
n=4 participants at risk
Interventional use of perioperative analgesia with acetaminophen and opioids that is supplemented with gabapentin solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and gabapentin.
Gabapentin: Use of Gabapentin peri- and post-operatively.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • 30 days
Any known untoward event of any severity that occurs subsequent to the AE reporting period that the Investigator assesses as at least possibly related to the study therapy (i.e., the relationship cannot be ruled out) should also be reported as an AE.
|
25.0%
1/4 • Number of events 1 • 30 days
Any known untoward event of any severity that occurs subsequent to the AE reporting period that the Investigator assesses as at least possibly related to the study therapy (i.e., the relationship cannot be ruled out) should also be reported as an AE.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • 30 days
Any known untoward event of any severity that occurs subsequent to the AE reporting period that the Investigator assesses as at least possibly related to the study therapy (i.e., the relationship cannot be ruled out) should also be reported as an AE.
|
25.0%
1/4 • Number of events 1 • 30 days
Any known untoward event of any severity that occurs subsequent to the AE reporting period that the Investigator assesses as at least possibly related to the study therapy (i.e., the relationship cannot be ruled out) should also be reported as an AE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place