Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
NCT Number: NCT02293447
Uterine artery embolization (UAE) is a minimally invasive treatment for women with symptomatic fibroids. It is similar to hysterectomy in term of satisfaction and symptoms improvement, with fewer complications and at lower cost. However, the majority of women undergoing UFE experience important pain after the procedure despite optimal analgesia, with one third reporting pain equal or worse than labor. Pain is the more common cause of prolonged hospital stay or readmission. There is need for a simple, efficient way to reduce post-procedural pain.
For this prospective randomized study, the hypothesis is that an anesthetic drug, lidocaine, injected in the uterine arteries diminishes pain post-UFE. Patients will be randomized in 3 groups: control, lidocaine injected during embolization, and lidocaine injected after embolization. Pain will be evaluated using a validated scale at 4h and 24h post-intervention. Hospital length-of-stay and total narcotic dose administered will be evaluated in the three groups.
This is the first Canadian study evaluating lidocaine use for pain control in UFE patients. Results will be transferable to clinical practice, considering the use of lidocaine is simple and cost is negligible. It could have a great impact on pain management in women undergoing UFE in all practice settings.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Phase 4
Toronto, Ontario, M5T 2S8, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10mL of 1% lidocaine will be mixed with the embolization particles. Lidocaine will therefore be injected during the embolization.
Other names: Local anesthetic, Amide-type anesthetic, Lidocaine hydrochloride, 00884154
10mL of 1% lidocaine will be injected in both uterine arteries after the embolization endpoint is achieved.
Other names: Local anesthetic, Amide-type anesthetic, Lidocaine hydrochloride, 00884154
Time frame: 4h post-procedure
Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS) filled by patients at 4h, 7h and 24h post-procedure. At 4h, patients will report the worst pain they experienced since end of procedure. At 7h and 24h, pain at time of assessment will be recorded.
Time frame: 7h post-procedure
Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS)
Time frame: 24 hours post-intervention
Estimated in hours, the length-of-stay will be evaluated from the end of procedure to discharge.
Time frame: 24 hours post-intervention
The total amount on narcotic doses administered to patient during the first 24hours post-procedure will be recorded.
Time frame: 24 hours post-procedure
Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS)
University Health Network, Toronto
Other
Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization : a Single-center Prospective Randomized Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02829333
Agnosia, Connective Tissue Diseases
View Trial DetailsNCT00340288
Connective Tissue Diseases, Leiomyoma
Chapel Hill, North Carolina, United States
View Trial DetailsNCT00295217
Connective Tissue Diseases, Leiomyoma
La Jolla, California, United States
View Trial DetailsNCT01936493
Connective Tissue Diseases, Fibroids
Rochester, Minnesota, United States
View Trial Details