Lee JT, Agar M, Phillips JL, Rao A, Huang E , et al.
BMC palliative care •
BACKGROUND: Optimal intervention and clinical trial designs require consumer contributions. The experience of people with advanced cancer and palliative care needs in neuropathic pain trials is seldom reported. METHODS: This exploratory descriptive qualitative sub-study aimed to understand the experience of patients and carers participating in the Lidocaine for Neuropathic Cancer Pain (LiCPain) study, a pilot randomised controlled trial of continuous subcutaneous infusion of lidocaine hydrochloride or placebo over 72 h in people with unrelieved neuropathic cancer pain. All participants enrolled in the trial, conducted at five Australian palliative care inpatient sites, were intended to be invited to participate at the time of consenting to the main study. Reasons for not being invited, consenting to or completing the interview sub-study were not collected. A single face-to-face or telephone interview was audio recorded by the site study team nurses or doctors using a semi-structured interview guide. Data were analysed following Braun and Clarke thematic analysis approach. RESULTS: Out of 17 participants randomised to the LiCPain trial, seven participants and one carer consented to participate in the qualitative sub-study. Three major themes were identified: • Trial participation offered a sense of hope and purpose; • The impact of the intervention has multiple contributing factors; and • Pain impacts every aspect of life. CONCLUSIONS: Participants found hope and purpose in the Lidocaine for Neuropathic Cancer Pain trial. Contextual factors influenced perceived effectiveness. These findings will inform future intervention designs and clinical trials to improve outcomes for people experiencing unrelieved neuropathic cancer pain. TRIAL REGISTRATION: This trial was registered in the Australian New Zealand Clinical Trials Registry (ACTRN12617000747325) on 22nd May 2017.
Lee JT, Lovell MR, Ritchie M, Butcher BE, Sheehan C , et al.
Journal of pain and symptom management •
Extended continuous subcutaneous infusion of lidocaine for neuropathic cancer pain is currently used in clinical practice. To determine the feasibility of conducting an adequately powered, multisite, double-blind, parallel group, titrated dose, randomized controlled trial of continuous subcutaneous infusion of lidocaine versus placebo in palliative care patients with neuropathic cancer pain. Adults with neuropathic cancer pain were randomized to receive lidocaine hydrochloride 10%w/v (3000 mg/30 mL) diluted in sodium chloride 0.9% or sodium chloride 0.9% as a continuous subcutaneous infusion titrated daily for 72 hours. The dose increased from 1 to 2 mg/kg/h, capped at 120mg/hour (2800mg/day, rounded down). Seventeen participants were recruited over 54 months. There was a 93% [95%CI 88%-98%] completion rate of study medication and procedures meeting the predefined feasibility criteria. Eighty-eight percent of participants completed 72 hours of study medication. Treatment-emergent adverse events were infrequent and generally mild or moderate nervous system, cardiac and vascular abnormalities. There were no electrocardiogram abnormalities. Rapid titration from 1 to 2 mg/kg/h was tolerated. Both intervention and control groups demonstrated a reduction in pain intensity with no significant difference. This pilot demonstrates that a phase III clinical trial of extended continuous subcutaneous infusion of lidocaine for neuropathic cancer pain is feasible and provides important insights into modifications required to improve recruitment. Serum levels and relative safety suggest higher lidocaine doses could be cautiously evaluated. As the only prospective trial we are aware of to date, this trial informs clinical use of subcutaneous lidocaine infused over days.
Hussain N, Brull R, Weber L, Garrett A, Werner M , et al.
British journal of anaesthesia •
Breast cancer is the most common cancer among women and tumour resection carries a high prevalence of chronic persistent postsurgical pain (CPSP). Perioperative i.v. lidocaine infusion has been proposed as protective against CPSP; however, evidence of its benefits is conflicting. This review evaluates the effectiveness of perioperative lidocaine infusions for breast cancer surgery. Randomised trials comparing perioperative lidocaine infusions with parenteral analgesia in breast cancer surgery patients were sought. The two co-primary outcomes were the odds of CPSP at 3 and 6 months after operation. Secondary outcomes included rest pain at 1, 6, 12, and 24 h; analgesic consumption at 0-24 and 25-48 h; quality of recovery; opioid-related side-effects; and lidocaine infusion side-effects. Hartung-Knapp-Sidik-Jonkman (HKSJ) random effects modelling was used. Thirteen trials (1039 patients; lidocaine: 518, control: 521) were included. Compared with control, perioperative lidocaine infusion did not decrease the odds of developing CPSP at 3 and 6 months. Lidocaine infusion improved postoperative pain at 1 h by a mean difference (95% confidence interval) of -0.65 cm (-0.73 to -0.57 cm) (P<0.0001); however, this difference was not clinically important (1.1 cm threshold). Similarly, lidocaine infusion reduced oral morphine consumption by 7.06 mg (-13.19 to -0.93) (P=0.029) over the first 24 h only; however, this difference was not clinically important (30 mg threshold). The groups were not different for any of the remaining outcomes. Our results provide moderate-quality evidence that perioperative lidocaine infusion does not reduce CPSP in patients undergoing breast cancer surgery. Routine use of lidocaine infusions for perioperative analgesia and CPSP prevention is not supported in this population. PROSPERO CRD42023420888.