Uterine FibroidsPhase 4NCT01555073
Preemptive Analgesia Following Uterine Artery Embolization
A Phase 4 study testing pregabalin/celecoxib in people with Uterine Fibroids and Uterine Artery Embolization, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Uterine Fibroids, Uterine Artery Embolization
- What is being tested?
- pregabalin/celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female patients (>18 years of age) who are undergoing elective uterine artery embolization will be included in the study.
Who cannot join
- Exclusion criteria for the study are patient refusal to be included in the study, the presence of language barrier that inhibits proper communication with the patient
- Contraindications to regional anesthesia
- History of allergy to amide local anesthetics or narcotics
- Known hypersensitivity to pregabalin, creatinine clearance ≤ 60 mL/min
- The presence of a progressive neurological deficit
- The presence of chronic opioid analgesia
Show all 11Show fewer
- The presence of a coagulopathy or infection, pregnancy
- Patients with cardiovascular disease
- Patients who take daily antiplatelet medications, patients with peptic ulcer disease
- History of psychiatric disorder or inability to follow study protocol.
- Dropout criteria include failed epidural analgesia, inability to tolerate side effects (nausea) from pregabalin, and the inability to contact during follow up.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: A Prospective Randomized Blinded Placebo Controlled Comparison of Multimodal Pre-emptive Analgesia on Long Term Outcome Following Uterine Artery Embolization
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.
- Conditions
- Uterine Fibroids, Uterine Artery Embolization
- Being tested
- pregabalin/celecoxib, pregabalin/placebo, celecoxib/placebo, Placebo group
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalin/celecoxibDrug
Also called Celebrex, Lyrica
pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.
pregabalin/placeboDrug
Also called Lyrica
pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.
celecoxib/placeboDrug
Also called Celebrex
celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.
Placebo groupDrug
Also called Placebo
Placebo group, two placebo tablets day of surgery and twice a day for 13 days
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin/celecoxib group | Active comparator | pregabalin/celecoxib twice a day for 13 days. Receives: Drug: pregabalin/celecoxib |
| Pregabalin/placebo group | Active comparator | pregabalin/placebo twice a day for 13 days. Receives: Drug: pregabalin/placebo |
| Celecoxib/placebo group | Active comparator | celecoxib/placebo twice a day for 13 days. Receives: Drug: celecoxib/placebo |
| Placebo group | Placebo comparator | Placebo group, two placebo tablets day of surgery and twice a day for 13 days Receives: Drug: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Expected average of 12 weeks
Secondary outcomes (1)
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.
Measured: Expected average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionAug 2013
- Study completionOct 2013
Why it stopped: Subjects did not meet inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoun Nader, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555073
- Sponsor's protocol ID
- STU00004604
- Status last verified
- Jun 2016
- First submitted
- 14 Oct 2011
- Last updated
- 28 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Blinded Placebo Controlled Comparison of Multimodal Pre-emptive Analgesia on Long Term Outcome Following Uterine Artery Embolization
- ClinicalTrials.gov ID
- NCT01555073
- Acronym / sponsor ID
- STU00004604
- Conditions
- Uterine Fibroids, Uterine Artery Embolization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Subjects did not meet inclusion criteria
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Posted 18 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregabalin/celecoxib group | Active comparator | Drug: pregabalin/celecoxibpregabalin/celecoxib twice a day for 13 days. |
| Pregabalin/placebo group | Active comparator | Drug: pregabalin/placebopregabalin/placebo twice a day for 13 days. |
| Celecoxib/placebo group | Active comparator | Drug: celecoxib/placebocelecoxib/placebo twice a day for 13 days. |
| Placebo group | Placebo comparator | Drug: Placebo groupPlacebo group, two placebo tablets day of surgery and twice a day for 13 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult female patients (>18 years of age) who are undergoing elective uterine artery embolization will be included in the study.
Key exclusion criteria (11 listed)
- Exclusion criteria for the study are patient refusal to be included in the study, the presence of language barrier that inhibits proper communication with the patient
- Contraindications to regional anesthesia
- History of allergy to amide local anesthetics or narcotics
- Known hypersensitivity to pregabalin, creatinine clearance ≤ 60 mL/min
- The presence of a progressive neurological deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pregabalin/celecoxibAlso: Celebrex, Lyricapregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days. | Drug | Pregabalin/celecoxib group |
| pregabalin/placeboAlso: Lyricapregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days. | Drug | Pregabalin/placebo group |
| celecoxib/placeboAlso: Celebrexcelecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days. | Drug | Celecoxib/placebo group |
| Placebo groupAlso: PlaceboPlacebo group, two placebo tablets day of surgery and twice a day for 13 days | Drug | Placebo group |
Primary outcome
Post Operative Pain Control
Time frame: 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.
1 secondary outcome
Quality of Life
Time frame: Expected average of 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Uterine Fibroids
Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pregabalin/celecoxib in people with Uterine Fibroids and Uterine Artery Embolization, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative Pain Control (time frame: Expected average of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.