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

• ClinicalTrials.gov Identifier: NCT01660412
• Recruitment Status: Completed
• First Posted: August 8, 2012
• Results First Posted: November 20, 2017
• Last Update Posted: November 20, 2017
• Sponsor: University of Arkansas
• Collaborators: Howard J Barnhard, Resident Research Endowment.; UAMS DEPT of Radiology.
• Information provided by (Responsible Party): University of Arkansas

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Standard of Care First; Drug: ph Altered first	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Does Alkalinization of Technetium-99m Sulfur Colloid Reduce Perceived Pain Levels During Non-breast Sentinel Lymphoscintigraphy?
• Actual Study Start Date: August 1, 2012
• Actual Primary Completion Date: December 30, 2016
• Actual Study Completion Date: December 30, 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: pH altered first; 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; 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 Name: Sodium Bicarbonate first
Active Comparator: Standard of Care first; 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; 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 Name: Sodium Bicarbonate second

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 122 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Arkansas

UAMS

Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

University of Arkansas

Howard J Barnhard, Resident Research Endowment.

UAMS DEPT of Radiology.

Investigators

• Principal Investigator: James A Ntambi, MD; UAMS

  Study Documents (Full-Text)

Documents provided by University of Arkansas:

Study Protocol and Statistical Analysis Plan  [PDF] January 17, 2012

More Information

Publications of Results:

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.

Other Publications:

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.

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.

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT01660412
• Other Study ID Numbers: 31337
• First Posted: August 8, 2012
• Results First Posted: November 20, 2017
• Last Update Posted: November 20, 2017
• Last Verified: November 2017

Keywords provided by University of Arkansas:

Pain; Alkalinization; Technetium 99m Sulfur Colloid; sentinel lymphoscintigraphy?