Trial Outcomes & Findings for The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion (NCT NCT03104816)
NCT ID: NCT03104816
Last Updated: 2019-10-08
Results Overview
Determine the impact of administering a supplemental non-opioid analgesic drug such as IV/oral acetaminophen on total opioid dose administered over the perioperative period.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
28 participants
Primary outcome timeframe
Within 24 hours after surgery
Results posted on
2019-10-08
Participant Flow
28 patients were involved in study. 22 patients completed the study. Patients were recruited in the surgical clinic, preoperative clinic, preoperative surgical area.
Patients were included in the study according to their inclusion and exclusion criteria. There were no patients were excluded from study in the period after signing the consent to assignment to groups.
Participant milestones
| Measure |
Acetaminophen IV Soln 10 Milligram/Milliliter (MG/ML) (A)
Patients in group A will receive 1 g of IV acetaminophen 15 minutes prior to wound incision, and every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.
Acetaminophen IV Soln MG/ML
Hydromorphone
|
PO Acetaminophen (B)
Patients in group B will receive 1 g of PO acetaminophen prior to surgery, and 1 g of oral acetaminophen every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.
Acetaminophen
Hydromorphone
|
Hydromorphone (Control Arm) (C)
Patients in the control arm (Group C) will not receive acetaminophen for 24 hours.
Hydromorphone
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
6
|
|
Overall Study
COMPLETED
|
9
|
9
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
Acetaminophen IV Soln 10 Milligram/Milliliter (MG/ML) (A)
Patients in group A will receive 1 g of IV acetaminophen 15 minutes prior to wound incision, and every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.
Acetaminophen IV Soln MG/ML
Hydromorphone
|
PO Acetaminophen (B)
Patients in group B will receive 1 g of PO acetaminophen prior to surgery, and 1 g of oral acetaminophen every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.
Acetaminophen
Hydromorphone
|
Hydromorphone (Control Arm) (C)
Patients in the control arm (Group C) will not receive acetaminophen for 24 hours.
Hydromorphone
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
2
|
Baseline Characteristics
The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion
Baseline characteristics by cohort
| Measure |
Acetaminophen IV Soln 10 MG/ML (A)
n=9 Participants
Patients in group A will receive 1 g of IV acetaminophen 15 minutes prior to wound incision, and every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.
Acetaminophen IV Soln 10 MG/ML
Hydromorphone
|
PO Acetaminophen (B)
n=9 Participants
Patients in group B will receive 1 g of PO acetaminophen prior to surgery, and 1 g of oral acetaminophen every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.
Acetaminophen
Hydromorphone
|
Hydromorphone (Control Arm) (C)
n=4 Participants
Patients in the control arm (Group C) will not receive acetaminophen for 24 hours.
Hydromorphone
|
Total
n=22 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
4 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Number of analyzed participants in each group
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within 24 hours after surgeryDetermine the impact of administering a supplemental non-opioid analgesic drug such as IV/oral acetaminophen on total opioid dose administered over the perioperative period.
Outcome measures
| Measure |
Acetaminophen IV Soln 10 MG/ML (A)
n=9 Participants
Hydromorphone and IV Acetaminophen are given to this group
|
PO Acetaminophen (B)
n=9 Participants
Hydromorphone and PO acetaminophen are given to this group
|
Hydromorphone (Control Arm) (C)
n=4 Participants
Hydromorphone only is given to the patients in this group
|
|---|---|---|---|
|
Postoperative Opioid Use
PACU dose
|
1.2 mg
Standard Deviation 0.4
|
1.3 mg
Standard Deviation 0.3
|
1.7 mg
Standard Deviation 0.5
|
|
Postoperative Opioid Use
Ward dose
|
9.8 mg
Standard Deviation 2.9
|
10.4 mg
Standard Deviation 3.1
|
13 mg
Standard Deviation 5.5
|
Adverse Events
Acetaminophen IV Soln 10 MG/ML (A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PO Acetaminophen (B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hydromorphone (Control Arm) (C)
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