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

Study Overview
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Brief Summary
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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.

Official Title
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Does Alkalinization of Technetium-99m Sulfur Colloid Reduce Perceived Pain Levels During Non-breast Sentinel Lymphoscintigraphy?

Conditions
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Pain

Intervention / Treatment
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* Drug: Standard of Care First
* Drug: ph Altered first


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 122 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pH altered first<br>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. | Drug: ph Altered first<br>* 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.<br>* Other names: Sodium Bicarbonate first;|
| Active Comparator: Standard of Care first<br>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. | Drug: Standard of Care First<br>* 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.<br>* Other names: Sodium Bicarbonate second;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Pain Level | Immediately after receiving an injection, subjects will rate their perceived pain level, using a validated measure. Subject was asked to quantify the pain of every injection using a validated scale from 0 through 10, with 0 being no pain and 10 being severe pain that is disabling. The effect of treatment was estimated by taking the difference of the mean buffered and SOC pain scores and a paired t-test was used to test whether the mean difference was significantly different from 0. Perceived pain levels assessed after each injection were averaged for each participant. | immediately after administration (<1 min) of each injection (up to total 5 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Alkalinization, Technetium 99m Sulfur Colloid, sentinel lymphoscintigraphy?