Trial Outcomes & Findings for Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion (NCT NCT02061774)
NCT ID: NCT02061774
Last Updated: 2020-05-06
Results Overview
The Visual Analogue Scale (VAS) and Verbal Rating Scale (VRS) will be measured at 4 hour intervals for a 24-hr period - measures of pain intensity in clinical and research settings. 0-10 Numeric pain intensity scale. 0 is no pain, 5 is moderate pain, and 10 is worst possible pain
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
Q4 x 24 hours averaged
Results posted on
2020-05-06
Participant Flow
Participant milestones
| Measure |
Acetaminophen
1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours
Acetaminophen: 1 gram of intravenous Acetaminophen
|
PlaceboComparator
Placebo Comparator 0.9% NaCl 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
Placebo comparator: placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Acetaminophen
n=10 Participants
1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours
Acetaminophen: 1 gram of intravenous Acetaminophen
|
PlaceboComparator
n=11 Participants
Placebo Comparator 0.9% NaCl 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
Placebo comparator: placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
11 Participants
n=11 Participants
|
21 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
54.5 years
n=10 Participants
|
54.0 years
n=11 Participants
|
54.5 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
5 Participants
n=11 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
6 Participants
n=11 Participants
|
12 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
11 participants
n=11 Participants
|
21 participants
n=21 Participants
|
|
ASA score
ASA 1
|
1 participants
n=10 Participants
|
1 participants
n=11 Participants
|
2 participants
n=21 Participants
|
|
ASA score
ASA 2
|
6 participants
n=10 Participants
|
5 participants
n=11 Participants
|
11 participants
n=21 Participants
|
|
ASA score
ASA 3
|
3 participants
n=10 Participants
|
4 participants
n=11 Participants
|
7 participants
n=21 Participants
|
|
decompressions
1 decompression
|
9 Participants
n=10 Participants
|
9 Participants
n=11 Participants
|
18 Participants
n=21 Participants
|
|
decompressions
2 decompressions
|
1 Participants
n=10 Participants
|
2 Participants
n=11 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Q4 x 24 hours averagedThe Visual Analogue Scale (VAS) and Verbal Rating Scale (VRS) will be measured at 4 hour intervals for a 24-hr period - measures of pain intensity in clinical and research settings. 0-10 Numeric pain intensity scale. 0 is no pain, 5 is moderate pain, and 10 is worst possible pain
Outcome measures
| Measure |
Acetaminophen
n=10 Participants
1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours
Acetaminophen: 1 gram of intravenous Acetaminophen
|
PlaceboComparator
n=11 Participants
Placebo Comparator 0.9% NaCl 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
Placebo comparator: placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
|
|---|---|---|
|
VAS
|
6 score on a scale
Interval 4.0 to 7.2
|
8.5 score on a scale
Interval 4.8 to 10.0
|
SECONDARY outcome
Timeframe: 4-hr intervals for a 24-hr period averagedSedation will be measured on a scale of 1 to 5 at 4-hour intervals as follows: 1-completely awake; 2-awake but drowsy; 3 asleep, but responds to verbal commands; 4-asleep but responds to tactile stimuli; and 5-asleep and not responding to any stimuli.
Outcome measures
| Measure |
Acetaminophen
n=10 Participants
1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours
Acetaminophen: 1 gram of intravenous Acetaminophen
|
PlaceboComparator
n=11 Participants
Placebo Comparator 0.9% NaCl 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
Placebo comparator: placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
|
|---|---|---|
|
Level of 100% Sedation
|
10 participants of 100% sedation
|
11 participants of 100% sedation
|
SECONDARY outcome
Timeframe: 4-hour intervals (+/- 30 minutes) for 24-hrs averagedRoutine postoperative vital signs will be collected at 4-hour intervals (+/- 30 minutes) postoperatively respiratory rate, oxygen saturation, mean arterial pressure, and heart rate. Any reports of headache, dizziness, nausea, vomiting, pruritis, agitation, constipation, insomnia, bradycardia (Heart rate below 60 beats per minute), hypotension (MAP less than 30% of baseline), or urinary retention will be recorded throughout the study and will be treated appropriately as they occur, and the treatment medication will be stopped if determined to be a causative factor.
Outcome measures
| Measure |
Acetaminophen
n=10 Participants
1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours
Acetaminophen: 1 gram of intravenous Acetaminophen
|
PlaceboComparator
n=11 Participants
Placebo Comparator 0.9% NaCl 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
Placebo comparator: placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
|
|---|---|---|
|
Vital Signs
|
10 participants with 100% vitals completed
|
11 participants with 100% vitals completed
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of operationAmount of morphine used during surgery
Outcome measures
| Measure |
Acetaminophen
n=10 Participants
1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours
Acetaminophen: 1 gram of intravenous Acetaminophen
|
PlaceboComparator
n=11 Participants
Placebo Comparator 0.9% NaCl 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
Placebo comparator: placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
|
|---|---|---|
|
Total PCA Morphine
|
41.6 mg
Interval 29.0 to 67.5
|
36.6 mg
Interval 26.0 to 55.3
|
Adverse Events
Acetaminophen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PlaceboComparator
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