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OpenTrials
Completed

NCT Number: NCT01660412

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–122 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAMS

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard of Care First

Drug

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.

Other names: Sodium Bicarbonate second

ph Altered first

Drug

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 names: Sodium Bicarbonate first

Primary outcomes

  1. Perceived Pain Level

    Time frame: immediately after administration (<1 min) of each injection (up to total 5 minutes)

    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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • Howard J Barnhard, Resident Research Endowment.
  • UAMS DEPT of Radiology.

Registry information

Official study title

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

Acronym: buffering SLN

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 8, 2012
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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