Does Alkalinization Reduce Perceived Pain Levels During Sentinel Lymph Node Imaging?
NCT ID: NCT01660412
Last Updated: 2017-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2012-08-01
2016-12-30
Brief Summary
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In sites other then the breast, using Bicarbonate to make the injection's pH closer to natural, attempts to lower the pain levels will be performed.
Hypothesis: The perceived pain level during non breast sentinel lymph node techniques can be reduced by raising the pH of the injectate (Tc-99m SC) to near the physiologic level of pH 7.40.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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pH altered first
The first injection administered will be the pH altered solution. The second injection will be the standard of care solution (opposite order). The remaining injections will be randomly assigned as either standard of care or pH altered.
ph Altered first
For the first injection, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to \~7.40. For the second injection, the standard of care will be given, and randomly after that either standard of care, or pH altered will be given.
Standard of Care first
The first injection administered will be the standard of care solution (SOC). The second injection will be the pH altered solution. The remaining injections will be randomly assigned as either standard of care or pH altered.
Standard of Care First
For the second injection, and randomly after that, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to \~7.40.
Interventions
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Standard of Care First
For the second injection, and randomly after that, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to \~7.40.
ph Altered first
For the first injection, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to \~7.40. For the second injection, the standard of care will be given, and randomly after that either standard of care, or pH altered will be given.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients scheduled to receive two or more injections of Tc-99m SC for the purpose of clinical management of melanoma or who have had an excisional biopsy for melanoma of the thorax and appendicular structures.
Exclusion Criteria
* Patients scheduled to receive only a single injection of Tc-99m SC;
* Pregnant or breast feeding women.
18 Years
122 Years
ALL
No
Sponsors
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Howard J Barnhard, Resident Research Endowment.
UNKNOWN
UAMS DEPT of Radiology.
UNKNOWN
University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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James A Ntambi, MD
Role: PRINCIPAL_INVESTIGATOR
UAMS
Locations
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UAMS
Little Rock, Arkansas, United States
Countries
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References
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Fetzer S, Holmes S. Relieving the pain of sentinel lymph node biopsy tracer injection. Clin J Oncol Nurs. 2008 Aug;12(4):668-70. doi: 10.1188/08.CJON.668-670.
Stojadinovic A, Peoples GE, Jurgens JS, Howard RS, Schuyler B, Kwon KH, Henry LR, Shriver CD, Buckenmaier CC. Standard versus pH-adjusted and lidocaine supplemented radiocolloid for patients undergoing sentinel-lymph-node mapping and biopsy for early breast cancer (PASSION-P trial): a double-blind, randomised controlled trial. Lancet Oncol. 2009 Sep;10(9):849-54. doi: 10.1016/S1470-2045(09)70194-9. Epub 2009 Aug 5.
Johnston MJ, Ntambi JA, Hilliard N, Spencer HJ, Vaughn R, Owens SS, Myrick RS, Parker LD, Garner DA, Yarbrough TL. Reducing perceived pain levels during nonbreast lymphoscintigraphy. Clin Nucl Med. 2015 Dec;40(12):945-9. doi: 10.1097/RLU.0000000000000905.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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31337
Identifier Type: -
Identifier Source: org_study_id