Fast track — ArticlesStandard 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
Introduction
Sentinel-lymph-node (SLN) mapping and biopsy is the preferred axillary staging procedure for patients with early breast cancer. Staging accuracy is equivalent to axillary dissection, with lower rates of morbidity. Many studies have confirmed the accuracy of SLN mapping and biopsy using radiolabelled colloids or blue dye,1, 2, 3, 4, 5, 6, 7 but there has also been much controversy and technical variation with the technique. Many SLN injection techniques exist, including peritumoral or intraparenchymal, subdermal, dermal, and intratumoral (seldom used in the USA).8 Previously, we used peritumoral injection with technetium-99m-sulfur colloid and found an SLN identification of 93·2% and false-negative rate of 11·4%.9 We modified our approach to subareolar (subdermal) radioisotope injection after data showed improved SLN identification and false-negative rates with subdermal (96·3% and 6·4%, respectively) and dermal (98·0% and 6·5%) versus peritumoral (88·2% and 8·0%) radioactive colloid injection with or without blue dye.10 Subareolar[99mTc]Tc-sulfur colloid injection is a technically simple and practical approach; it allows for rapid axillary nodal uptake of radioisotope, avoids the overlap of radioactivity between peritumoral injection and SLN(s) for upper, outer quadrant, or multifocal lesions, and obviates the need for image-guided peritumoral injection for non-palpable breast cancers.
Surprisingly little has been published on pain related to radioisotope injection for lymphatic mapping in breast cancer. Krynyckyi and colleagues8, 11, 12 reported a reduction in cutaneous pain with the use of topical anaesthetics (EMLA cream [lidocaine 2·5% and prilocaine 2·5%], Astra Pharmaceuticals, Wayne, PA, USA) before intradermal radioisotope injection. The researchers reported adding lidocaine to the radioisotope preparation for shallow subareolar injections to improve patient comfort with the procedure, but they did not provide quantitative data or assess the effect of adding lidocaine on success of the nodal mapping technique. We have had success with subareolar injection as a technique; however, shallow subdermal sulfur colloid injections are more painful than intraparenchymal injections. To reduce pain, we included a topical anaesthetic (4% lidocaine cream), applied to the skin of the nipple-areolar complex 1 h before subareaolar injection of 4 mL [99mTc]Tc-sulfur colloid (1 mCi, 0·1 mL in 3·9 mL normal saline). We did not find this technique particularly effective for managing the pain associated with injection of low pH [99mTc]Tc-sulfur colloid, although others have reported effectiveness with topical anaesthetic creams, used in the same context, for control of local skin-surface pain.11, 12
In addition to a local anaesthetic, pH modification of the sulfur colloid has been suggested to improve patient comfort.8 We assessed whether pH adjustments or addition of 1% lidocaine to the radioisotope solution improves pain control, at time of injection, for patients undergoing SLN mapping for breast cancer.
Section snippets
Patients
140 patients were enrolled from January, 2006, to April, 2009, at the Walter Reed Army Medical Center in Washington, DC, USA. Eligible patients were those who presented with non-painful, biopsy-proven early stage (T1 or T2; node-negative) infiltrating breast cancer, without antecedent allergy to local anaesthetics, chronic pain syndromes (eg, fibromyalgia rheumatica), or active narcotic-based pharmacotherapy. Only patients who were not pregnant, older than 18 years of age, and capable of
Results
From Jan 13, 2006, to April 30, 2009, 140 patients were randomly assigned to one of the four study groups (figure 1). 28 patients in the control group, 31 patients in the sodium bicarbonate group, 32 patients in the 1% lidocaine group, and 30 patients in the sodium bicarbonate plus 1% lidocaine group completed the study protocol and were analysed for degree of pain at the time of subareolar injection of radioisotope (figure 1). Of the 19 patients who were excluded from the study, nine declined
Discussion
A significant degree of pain is associated with standard [99mTc]Tc-sulfur colloid injections for patients undergoing SLN mapping for breast cancer. Although modification of the pH of the radioisotope preparation, with sodium bicarbonate, provided no incremental benefit compared with the standard preparation, the addition of 1% lidocaine provided a significant reduction in pain associated with subareolar injection of sulfur colloid, according to both pain scales used in this study, and did not
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2019, Journal of Surgical ResearchCitation Excerpt :It was thought that this may be due to the pH of the agents. However, in the Stojadinovic study, there was no change in pain scores when the pH of SC was altered by mixing with bicarbonate.8 One possible reason for the increased pain could be the particle size.
Effect of Topical Anesthetic Cream on Pain During Periareolar Injection of Technetium Tc99m Sulfur Colloid for Sentinel Lymph Node Biopsy in Breast Cancer: A Randomized Control Trial
2018, Journal of Medical Imaging and Radiation SciencesCitation Excerpt :The Tc99m injection procedure is reported as one of the most painful aspects of breast cancer treatment [8]. In response to patient reports of distressing procedural pain, a scoping review [9] was conducted resulting in four different pain management modalities for consideration: (1) anesthetic cream [8, 10, 11]; (2) injection of sodium bicarbonate buffered lidocaine before injections of Tc99m [12]; (3) altering the radiopharmaceutical composition of Tc99m [13]; and (4) using an intraoperative injection technique [14–22]. Fetzer and Holmes reported significantly lower pain scores using an anesthetic cream protocol [10].
Do topical anesthetics reduce periareolar injectional pain before sentinel lymph node biopsy?
2011, American Journal of SurgeryCitation Excerpt :However, this made the control population's injection volume unusually high, at 4 mL, with the additional saline injected with the 99mTc sulfur colloid. The study reported that the lidocaine cream did not interfere with sentinel lymph node identification rates.21 Our study showed no significant reduction in pain scores when topical lidocaine/prilocaine was used before periareolar injection for sentinel lymph node biopsy.
Sentinel-lymph-node biopsy for breast cancer: the story is not yet over
2009, The Lancet OncologyPain Ratings by Patients and Their Providers of Radionucleotide Injection for Breast Cancer Lymphatic Mapping
2012, Pain Medicine (United States)Citation Excerpt :Patients with allergies to local anesthetics, who were previously diagnosed with chronic pain syndromes, or who were prescribed chronic opioid therapy were excluded. Randomization was done in a 1:1:1:1 ratio using a computer program based on random number generation [12]. All patients were covered under the TRICARE health system.