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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: ph Altered first; Drug: Standard of Care First

• Registration Number: NCT01660412
• Lead Sponsor: University of Arkansas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-01
• Study First Submitted: 2012-08-03
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-08
• Primary Completion: 2016-12-30
• Study Completion: 2016-12-30
• Status Verified: 2017-11
• Results First Submitted: 2017-11-14
• Results First Submitted QC: 2017-11-16
• Last Update Submitted: 2017-11-16
• Results First Posted: 2017-11-20
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
pH altered first	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.
Standard of Care first	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.

Primary Outcome Measures

Name	Time	Method
Perceived Pain Level	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.

Trial Locations

Locations (1)

UAMS; 🇺🇸 Little Rock, Arkansas, United States