Effect of Addition of Steroids on Duration of Analgesia
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| ClinicalTrials.gov Identifier: NCT04126824 |
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Recruitment Status :
Recruiting
First Posted : October 15, 2019
Last Update Posted : March 28, 2022
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Sponsor:
University of California, Los Angeles
Information provided by (Responsible Party):
Jessica K. Stewart, MD, University of California, Los Angeles
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Brief Summary:
The purpose of the study is to investigate the differences in post-procedural pain scores and narcotic use among patients who receive a Superior Hypogastric Nerve Block (SHNB) with and without corticosteroid performed as part of the Uterine Artery Embolization (UAE) procedure.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Uterine Fibroids Adenomyosis | Drug: Triamcinolone Drug: Bupivacaine Other: Iohexol contrast | Early Phase 1 |
Investigators will enroll a total of 28 women undergoing the UAE procedure with 14 subjects in each study arm. This investigation is a single blind randomized control trial investigating the post-procedural analgesic effect of adding a corticosteroid (Triamcinolone) as an adjuvant to a SHNB that contains bupivacaine for patients undergoing UAE, compared to patients undergoing nerve block for pain control following UAE with local anesthetic only. Before and after the procedure, patients will be asked to complete online surveys in order to record their pain score (measured on the Visual Analog Pain Scale), opioid and other pain medication use, and other symptoms, such as nausea.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 28 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Prospective Randomized Controlled Clinical Trial: Superior Hypogastric Nerve Block for Pain Control After Uterine Artery Embolization: Effect of Addition of Steroids on Duration of Analgesia |
| Actual Study Start Date : | November 5, 2019 |
| Estimated Primary Completion Date : | February 2024 |
| Estimated Study Completion Date : | February 2025 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Bupivacaine
During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine and contrast to enable visualization of the nerve block under fluoroscopy.
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Drug: Bupivacaine
0.5% bupivacaine (20 mL) administered as a Superior Hypogastric Nerve Block (SHNB).
Other Name: Marcaine, Exparel Other: Iohexol contrast The appropriate amount of contrast to enable visualization of the nerve block under fluoroscopy given as a Superior Hypogastric Nerve Block (SHNB) will be administered.
Other Name: Omnipaque |
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Experimental: Bupivacaine and Triamcinolone
During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine plus triamcinolone mixed with contrast to enable visualization of the nerve block under fluoroscopy.
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Drug: Triamcinolone
40 mg triamcinolone administered as a Superior Hypogastric Nerve Block (SHNB)
Other Name: Kenalog Drug: Bupivacaine 0.5% bupivacaine (20 mL) administered as a Superior Hypogastric Nerve Block (SHNB).
Other Name: Marcaine, Exparel Other: Iohexol contrast The appropriate amount of contrast to enable visualization of the nerve block under fluoroscopy given as a Superior Hypogastric Nerve Block (SHNB) will be administered.
Other Name: Omnipaque |
Primary Outcome Measures :
- Change in Pain Intensity Measure (mm) [ Time Frame: Baseline, 240 hours ]The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain".
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| Ages Eligible for Study: | 30 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- females
- aged between 30 and 60 years
- diagnosed with symptomatic uterine fibroids and/or adenomyosis and scheduled to undergo UAE procedure
Exclusion Criteria:
- Contraindications to UAE
- SHNB is deemed unsafe for the patient
- Allergies to local anesthetic or steroid agent
- History of inflammatory bowel disease or ulcerative colitis
- Uncorrectable abnormal coagulation profile
- Diabetes mellitus
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126824
Contacts
| Contact: Tammy L Floore | 310-794-9202 | tfloore@mednet.ucla.edu | |
| Contact: Saima Chaabane | 310-794-8995 | schaabane@mednet.ucla.edu |
Locations
| United States, North Carolina | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Hannah Mignosa 984-215-4963 hannah_mignosa@med.unc.edu | |
| Contact: Markeela Lipscomb 919-843-3670 markeela_lipscomb@med.unc.edu | |
| Principal Investigator: Clayton Commander, MD | |
Sponsors and Collaborators
University of California, Los Angeles
Investigators
| Principal Investigator: | Jessica K Stewart, MD | University of California, Los Angeles |
| Responsible Party: | Jessica K. Stewart, MD, Principal Investigator, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT04126824 |
| Other Study ID Numbers: |
21-001880 |
| First Posted: | October 15, 2019 Key Record Dates |
| Last Update Posted: | March 28, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Keywords provided by Jessica K. Stewart, MD, University of California, Los Angeles:
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Uterine Artery Embolization |
Additional relevant MeSH terms:
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Leiomyoma Adenomyosis Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Uterine Diseases Triamcinolone Bupivacaine Anesthetics, Local |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |