Trial Outcomes & Findings for Preemptive Analgesia Following Uterine Artery Embolization (NCT NCT01555073)
NCT ID: NCT01555073
Last Updated: 2016-07-28
Results Overview
To evaluate the post operative pain control of the four groups in immediate postoperative period and months following uterine artery embolisation procedure.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
Expected average of 12 weeks
Results posted on
2016-07-28
Participant Flow
Participant milestones
| Measure |
Pregabalin/Celecoxib Group
pregabalin/celecoxib twice a day for 13 days.
pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.
|
Pregabalin/Placebo Group
pregabalin/placebo twice a day for 13 days.
pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.
|
Celecoxib/Placebo Group
celecoxib/placebo twice a day for 13 days.
celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.
|
Placebo Group
Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
7
|
6
|
|
Overall Study
COMPLETED
|
6
|
1
|
7
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
5
|
Reasons for withdrawal
| Measure |
Pregabalin/Celecoxib Group
pregabalin/celecoxib twice a day for 13 days.
pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.
|
Pregabalin/Placebo Group
pregabalin/placebo twice a day for 13 days.
pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.
|
Celecoxib/Placebo Group
celecoxib/placebo twice a day for 13 days.
celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.
|
Placebo Group
Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
5
|
Baseline Characteristics
Preemptive Analgesia Following Uterine Artery Embolization
Baseline characteristics by cohort
| Measure |
Pregabalin/Celecoxib Group
n=7 Participants
pregabalin/celecoxib twice a day for 13 days.
pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.
|
Pregabalin/Placebo Group
n=3 Participants
pregabalin/placebo twice a day for 13 days.
pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.
|
Celecoxib/Placebo Group
n=7 Participants
celecoxib/placebo twice a day for 13 days.
celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.
|
Placebo Group
n=6 Participants
Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days
|
Total
n=23 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Expected average of 12 weeksPopulation: Early termination due to lost of follow-up for primary outcome at 3 months
To evaluate the post operative pain control of the four groups in immediate postoperative period and months following uterine artery embolisation procedure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Expected average of 12 weeksPopulation: Early termination due to lost of follow-up for primary outcome at 3 months
To register the quality of life of patients receiving the four study arms following uterine artery embolisation during immediate and long term time periods.
Outcome measures
Outcome data not reported
Adverse Events
Pregabalin/Celecoxib Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pregabalin/Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Celecoxib/Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
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
Antoun Nader, MD
Northwestern University, Feinberg School of Medicine
Phone: 312-695-3045
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place