Does Alkalinization Reduce Perceived Pain Levels During Sentinel Lymph Node Imaging? (buffering SLN)

University of Arkansas

Status: Completed

Conditions: Pain

Treatments: Drug: ph Altered first; Drug: Standard of Care First

Study type: Interventional

Funder types: Other

Identifiers

NCT01660412

31337

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 122 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

pH altered first

Active Comparator group

Description:

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.

Treatment:

Drug: ph Altered first

Standard of Care first

Active Comparator group

Description:

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.

Treatment:

Drug: Standard of Care First