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A Prospective Randomized Blinded Placebo Controlled Comparison of Multimodal Pre-emptive Analgesia on Long Term Outcome Following Uterine Artery Embolization


Phase 4
18 Years
65 Years
Open (Enrolling)
Female
Uterine Fibroids, Uterine Artery Embolization

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Trial Information

A Prospective Randomized Blinded Placebo Controlled Comparison of Multimodal Pre-emptive Analgesia on Long Term Outcome Following Uterine Artery Embolization


Inclusion Criteria:



- Adult female patients (>18 years of age) who are undergoing elective uterine artery
embolization will be included in the study.

Exclusion Criteria:

- 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

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

post operative pain control

Outcome Description:

To evaluate the post operative pain control of the four groups in immediate postoperative period and months following uterine artery embolisation procedure.

Outcome Time Frame:

Expected average of 12 weeks

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

STU00004604

NCT ID:

NCT01555073

Start Date:

October 2011

Completion Date:

Related Keywords:

  • Uterine Fibroids
  • Uterine Artery Embolization
  • Leiomyoma
  • Myofibroma

Name

Location

Northwestern Memorial HospitalChicago, Illinois  60611