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

Pain Clinical Trial

— buffering SLN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660412
• Other study ID #: 31337
• Status: Completed
• Phase: N/A
• First received: August 3, 2012
• Last updated: November 16, 2017
• Start date: August 1, 2012
• Est. completion date: December 30, 2016

Study information

• Verified date: November 2017
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2016
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 122 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	UAMS	Little Rock	Arkansas

Sponsors (3)

Lead Sponsor	Collaborator
University of Arkansas	Howard J Barnhard, Resident Research Endowment., UAMS DEPT of Radiology.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)