Trial Outcomes & Findings for Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery (NCT NCT03115151)
NCT ID: NCT03115151
Last Updated: 2023-10-26
Results Overview
Postoperative Visual Analog Pain Score following lumbar fusion surgery. VAS on the scale 0 to 100 (0= no pain, 100= worst pain).
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
VAS score at postoperative 24 hours
Results posted on
2023-10-26
Participant Flow
Participant milestones
| Measure |
Patient-Controlled Epidural Analgesia
Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours
Bupivacaine: Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter
Fentanyl: Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine.
|
Intravenous Patient-controlled Analgesia
Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone
Hydromorphone: Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL).
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Patient-Controlled Epidural Analgesia
Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours
Bupivacaine: Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter
Fentanyl: Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine.
|
Intravenous Patient-controlled Analgesia
Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone
Hydromorphone: Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL).
|
|---|---|---|
|
Overall Study
Intervention discontinue due to clinical condition
|
2
|
2
|
|
Overall Study
Epidural catheter removal
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Intervention not received according to the protocol.
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Randomization not applied
|
1
|
1
|
Baseline Characteristics
Analysis sample is lower than total enrollment number because all participants could not completed study.
Baseline characteristics by cohort
| Measure |
Patient-Controlled Epidural Analgesia
n=17 Participants
Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours
Bupivacaine: Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter
Fentanyl: Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine.
|
Intravenous Patient-controlled Analgesia
n=18 Participants
Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone
Hydromorphone: Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL).
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants • Analysis sample is lower than total enrollment number because all participants could not completed study.
|
0 Participants
n=4 Participants • Analysis sample is lower than total enrollment number because all participants could not completed study.
|
0 Participants
n=27 Participants • Analysis sample is lower than total enrollment number because all participants could not completed study.
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants • Analysis sample is lower than total enrollment number because all participants could not completed study.
|
9 Participants
n=4 Participants • Analysis sample is lower than total enrollment number because all participants could not completed study.
|
14 Participants
n=27 Participants • Analysis sample is lower than total enrollment number because all participants could not completed study.
|
|
Age, Categorical
>=65 years
|
12 Participants
n=93 Participants • Analysis sample is lower than total enrollment number because all participants could not completed study.
|
9 Participants
n=4 Participants • Analysis sample is lower than total enrollment number because all participants could not completed study.
|
21 Participants
n=27 Participants • Analysis sample is lower than total enrollment number because all participants could not completed study.
|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 6 • n=93 Participants
|
60 years
STANDARD_DEVIATION 14 • n=4 Participants
|
63.37 years
STANDARD_DEVIATION 11.36 • n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Preoperative Pain Score
|
39.47 units on a scale (0 to 100)
STANDARD_DEVIATION 23.09 • n=93 Participants
|
35.38 units on a scale (0 to 100)
STANDARD_DEVIATION 26.40 • n=4 Participants
|
37.37 units on a scale (0 to 100)
STANDARD_DEVIATION 24.57 • n=27 Participants
|
PRIMARY outcome
Timeframe: VAS score at postoperative 24 hoursPopulation: Spinal fusion surgeries level 1 to 3.
Postoperative Visual Analog Pain Score following lumbar fusion surgery. VAS on the scale 0 to 100 (0= no pain, 100= worst pain).
Outcome measures
| Measure |
Patient-Controlled Epidural Analgesia
n=17 Participants
Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours
Bupivacaine: Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter
Fentanyl: Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine.
|
Intravenous Patient-controlled Analgesia
n=18 Participants
Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone
Hydromorphone: Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL).
|
|---|---|---|
|
Visual Analog Pain Score (VAS)
|
40.23 units on a scale
Standard Deviation 24.69
|
54.27 units on a scale
Standard Deviation 25.41
|
Adverse Events
Patient-Controlled Epidural Analgesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intravenous Patient-controlled Analgesia
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