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

NCT01660412 | Completed Results DMC

• 1 other identifier: 31337
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

pH altered first

ACTIVE COMPARATOR

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

Standard of Care first

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Sodium Bicarbonate second

Standard of Care first

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.

Also known as: Sodium Bicarbonate first

pH altered first

Eligibility Criteria

• Age: 18 Years - 122 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead
• Howard J Barnhard, Resident Research Endowment.: collaborator
• UAMS DEPT of Radiology.: collaborator

Study Sites (1)

UAMS

Little Rock, Arkansas, 72205, United States

Location

Related 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.

  PMID: 18676334 BACKGROUND

• 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.

  PMID: 19664956 BACKGROUND

• 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.

  PMID: 26222533 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

a sample size of 60 may be inadequate to generalize to all practices.

Results Point of Contact

• Title: James A Ntambi
• Organization: UAMS

jantambi@uams.edu

5015265062

Study Officials

• James A Ntambi, MD

  UAMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: August 8, 2012
• Study Start: August 1, 2012
• Primary Completion: December 30, 2016
• Study Completion: December 30, 2016
• Last Updated: November 20, 2017
• Results First Posted: November 20, 2017

Record last verified: 2017-11

Locations

US (1)