Does Alkalinization Reduce Perceived Pain Levels During Sentinel Lymph Node Imaging?

Completed · Not applicable

Conditions studied: Pain

In brief

Pain during nuclear medicine breast lymphnode detection procedures has been reported as high as 8.8/10. Using Sodium Bicarbonate to alkalinize the radio-pharmaceutical injection, pain can safely be reduced from 6.6/10 to 4.7/10, during breast lymph node detection procedures. 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.

Key facts

Study ID

NCT01660412

Run by

University of Arkansas

People needed

60

Starts

2012-08-01

Expected to finish

2016-12-30

Last updated by the study team

2017-11-20

Who can join

Age: 18 and older, up to 122. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients presenting for SLN imaging for melanoma or who have had an excisional biopsy for melanoma of the thorax and appendicular structures;
• 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.

You may not qualify if…

• Patients presenting for SLN imaging of lesions involving the breast, ear, nose, and genitourinary regions;
• Patients scheduled to receive only a single injection of Tc-99m SC;
• Pregnant or breast feeding women.

Where it is running

• UAMS — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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