Preemptive Analgesia Following Uterine Artery Embolization

NCT01555073 | Terminated Phase 4 Results

• 1 other identifier: STU00004604
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Fibroids; Uterine Artery Embolization

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Quality of Life

  Expected average of 12 weeks

Study Arms (4)

Pregabalin/celecoxib group

ACTIVE COMPARATOR

pregabalin/celecoxib twice a day for 13 days.

Drug: pregabalin/celecoxib

Pregabalin/placebo group

ACTIVE COMPARATOR

pregabalin/placebo twice a day for 13 days.

Drug: pregabalin/placebo

Celecoxib/placebo group

ACTIVE COMPARATOR

celecoxib/placebo twice a day for 13 days.

Drug: celecoxib/placebo

Placebo group

PLACEBO COMPARATOR

Placebo group, two placebo tablets day of surgery and twice a day for 13 days

Drug: Placebo group

Interventions

pregabalin/celecoxib DRUG

pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.

Also known as: Celebrex, Lyrica

Pregabalin/celecoxib group

pregabalin/placebo DRUG

pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.

Also known as: Lyrica

Pregabalin/placebo group

celecoxib/placebo DRUG

celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.

Also known as: Celebrex

Celecoxib/placebo group

Placebo group DRUG

Placebo group, two placebo tablets day of surgery and twice a day for 13 days

Also known as: Placebo

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

Pregabalin; Celecoxib

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination due to lost of follow-up for primary outcome at 3 months

Results Point of Contact

• Title: Antoun Nader, MD
• Organization: Northwestern University, Feinberg School of Medicine

a-nader2@northwestern.edu

312-695-3045

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Anesthesiology and Orthopaedic Surgery

Study Record Dates

• First Submitted: October 14, 2011
• First Posted: March 15, 2012
• Study Start: October 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 28, 2016
• Results First Posted: September 18, 2014

Record last verified: 2016-06

Locations

US (1)