Uterine Artery Embolization, Uterine Fibroids
Conditions
Brief summary
Uterine leiomyomata, also known as fibroids, are an extremely common benign lesion being present in 30-50% of all women. Traditional surgical treatment of symptomatic fibroids has been hysterectomy in post child bearing woman. However, over the last decade, the use of a minimal invasive technique called uterine artery embolization has become increasingly popular due to high patient satisfaction, cost effectiveness, and shorter recovery period. The purpose of this randomized blinded placebo controlled study is to compare pre-emptive analgesia vs non-preemptive analgesia for immediate postoperative pain control, long term pain control, and improved quality of life in woman following uterine artery embolization surgery. The study consists of four drug groups including a placebo group. The addition of pregabalin and celecoxib together with epidural analgesia may improve pain management as well as leading to a better post-procedure outcome in women following uterine artery embolization. Many investigators believe that the ischemia in the normal myometrium is the primary source of pain immediately following surgery making postoperative pain management challenging. Epidural fentanyl may offer an advantage when encountering visceral pain. In addition to being an effective analgesic for chronic pain syndromes, the use of pregabalin provides effective postoperative analgesia when it is administered pre-emptively before an operation. Preemptive analgesia involves the introduction of an analgesic regimen before the onset of noxious stimuli, with the goal of preventing sensitization of the nervous system to subsequent stimuli that could amplify pain. In human trials, pregabalin has been demonstrated to reduce pain, improve sleep, and mood disturbances in patients with post herpetic neuralgia. The use of celecoxib in combination with pregabalin has shown to provide more effective analgesia by providing antihyperalgesia. Therefore, the addition of pregabalin and celecoxib together with epidural analgesia may improve pain management as well as having an effect on long term sequelae.
Interventions
DRUGpregabalin/celecoxib
pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.
DRUGpregabalin/placebo
pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.
DRUGcelecoxib/placebo
celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.
DRUGPlacebo group
Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult female patients (\>18 years of age) who are undergoing elective uterine artery embolization will be included in the study.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain Control | Expected average of 12 weeks | To evaluate the post operative pain control of the four groups in immediate postoperative period and months following uterine artery embolisation procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | Expected average of 12 weeks | To register the quality of life of patients receiving the four study arms following uterine artery embolisation during immediate and long term time periods. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 3 |
| 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. | 7 |
| 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 | 6 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 | 0 | 5 |
Baseline characteristics
| Characteristic | Pregabalin/Celecoxib Group | Pregabalin/Placebo Group | Celecoxib/Placebo Group | Placebo Group | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 3 Participants | 7 Participants | 6 Participants | 23 Participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 7 Participants | 6 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 6 |
Outcome results
Primary
Post Operative Pain Control
To evaluate the post operative pain control of the four groups in immediate postoperative period and months following uterine artery embolisation procedure.
Time frame: Expected average of 12 weeks
Population: Early termination due to lost of follow-up for primary outcome at 3 months
Secondary
Quality of Life
To register the quality of life of patients receiving the four study arms following uterine artery embolisation during immediate and long term time periods.
Time frame: Expected average of 12 weeks
Population: Early termination due to lost of follow-up for primary outcome at 3 months