Effect of Continuous Lidocaine Infusion for the Management of Cancer Pain in the Patients with Terminal Gastrointestinal Carcinoma

Amikura, Katsumi; Kobayashi, Tatsuya; Takeshita, Y; Kawashima, Yasunaru; Nishimura, Youji; Sakamoto, Hirohiko; Tanaka, Youichi; Yomiya, Kinomi; Matsuo, Naoki; Fujii, Yukihiko

doi:10.5833/jjgs.37.117

Cited by 2 publications

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“…In two patients, recurrent pain was associated with lidocaine blood concentrations under 2 µg/mL. Amikura 16 gave 32 patients with neuropathic cancer pain lidocaine with an average maintenance dose of 38 mg/hour (range: 8–60 mg/hour) for 5–158 days, and 87.5% experienced significant pain relief. Seah et al 43 reported 23 hospice patients with a median subcutaneous lidocaine dose of 0.65 mg/kg/hour.…”

Section: Methods and Analysismentioning

confidence: 99%

“…Three observational studies have found 67%-87% response to continuous subcutaneous or intravenous lidocaine infusion in cancer pain or palliative care patients. [16][17][18] A 2015 Cochrane review found that lidocaine as a bolus dose or a short infusion is safe and more effective than placebo in treating chronic, noncancer neuropathic pain, 19 as well as better than placebo for early postoperative pain. 20 A meta-analysis 9 of bolus intravenous lidocaine 4-5 mg/kg over 30-80 min versus placebo in cancer pain showed a significant benefit for >50% reduction in cancer pain but not other outcomes.…”

Section: Strengths and Limitations Of This Studymentioning

confidence: 99%

“…Data support lidocaine as a promising, safe agent in this setting, warranting further evaluation in robust, randomised controlled trials. Three observational studies have found 67%–87% response to continuous subcutaneous or intravenous lidocaine infusion in cancer pain or palliative care patients 16–18. A 2015 Cochrane review found that lidocaine as a bolus dose or a short infusion is safe and more effective than placebo in treating chronic, non-cancer neuropathic pain,19 as well as better than placebo for early postoperative pain 20.…”

Section: Introductionmentioning

confidence: 99%

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Lidocaine for Neuropathic Cancer Pain (LiCPain): study protocol for a mixed-methods pilot study

et al. 2023

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IntroductionMany patients experience unrelieved neuropathic cancer-related pain. Most current analgesic therapies have psychoactive side effects, lack efficacy data for this indication and have potential medication-related harms. The local anaesthetic lidocaine (lignocaine) has the potential to help manage neuropathic cancer-related pain when administered as an extended, continuous subcutaneous infusion. Data support lidocaine as a promising, safe agent in this setting, warranting further evaluation in robust, randomised controlled trials. This protocol describes the design of a pilot study to evaluate this intervention and explains the pharmacokinetic, efficacy and adverse effects evidence informing the design.Methods and analysisA mixed-methods pilot study will determine the feasibility of an international first, definitive phase III trial to evaluate the efficacy and safety of an extended continuous subcutaneous infusion of lidocaine for neuropathic cancer-related pain. This study will comprise: a phase II double-blind randomised controlled parallel-group pilot of subcutaneous infusion of lidocaine hydrochloride 10% w/v (3000 mg/30 mL) or placebo (sodium chloride 0.9%) over 72 hours for neuropathic cancer-related pain, a pharmacokinetic substudy and a qualitative substudy of patients’ and carers’ experiences. The pilot study will provide important safety data and help inform the methodology of a definitive trial, including testing proposed recruitment strategy, randomisation, outcome measures and patients’ acceptability of the methodology, as well as providing a signal of whether this area should be further investigated.Ethics and disseminationParticipant safety is paramount and standardised assessments for adverse effects are built into the trial protocol. Findings will be published in a peer-reviewed journal and presented at conferences. This study will be considered suitable to progress to a phase III study if there is a completion rate where the CI includes 80% and excludes 60%. The protocol and Patient Information and Consent Form have been approved by Sydney Local Health District (Concord) Human Research Ethics Committee 2019/ETH07984 and University of Technology Sydney ETH17-1820.Trial registration numberANZCTR ACTRN12617000747325.

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Section: Methods and Analysismentioning

confidence: 99%