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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin/celecoxib group | Active Comparator | pregabalin/celecoxib twice a day for 13 days. |
|
| Pregabalin/placebo group | Active Comparator | pregabalin/placebo twice a day for 13 days. |
|
| Celecoxib/placebo group | Active Comparator | celecoxib/placebo twice a day for 13 days. |
|
| Placebo group | Placebo Comparator | Placebo group, two placebo tablets day of surgery and twice a day for 13 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabalin/celecoxib | Drug | pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Expected average of 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Expected average of 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Analysis population description
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Pregabalin/Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Early termination due to lost of follow-up for primary outcome at 3 months | Posted | Expected average of 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Early termination due to lost of follow-up for primary outcome at 3 months
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antoun Nader, MD | Northwestern University, Feinberg School of Medicine | 312-695-3045 | a-nader2@northwestern.edu |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| pregabalin/placebo | Drug | pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days. |
|
|
| celecoxib/placebo | Drug | celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days. |
|
|
| Placebo group | Drug | Placebo group, two placebo tablets day of surgery and twice a day for 13 days |
|
|
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.
| BG002 | 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. |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | 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. |
| OG003 | 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 |
|
| 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. | Early termination due to lost of follow-up for primary outcome at 3 months | Posted | Expected average of 12 weeks |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 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. | 0 | 3 | 0 | 3 |
| EG002 | 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. | 0 | 7 | 0 | 7 |
| EG003 | 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 | 0 | 6 | 0 | 6 |
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |