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Clinical Trial
. 2024 Sep 1;15(9):e1.
doi: 10.14309/ctg.0000000000000760.

Intravenous Lidocaine for Refractory Pain in Patients With Pancreatic Ductal Adenocarcinoma and Chronic Pancreatitis: A Multicenter Prospective Nonrandomized Pilot Study

Simone Augustinus  1   2 , Matthanja Bieze  3   4 , Charlotte L Van Veldhuisen  1   2 , Marja A Boermeester  1   2 , Bert A Bonsing  5 , Stefan A W Bouwense  6 , Marco J Bruno  7 , Olivier R Busch  1   2 , Werner Ten Hoope  8 , Jan-Willem Kallewaard  3   8 , Henk J van Kranen  9 , Marieke Niesters  10 , Niels C J Schellekens  3 , Monique A H Steegers  3 , Rogier P Voermans  11 , Judith de Vos-Geelen  12 , Johanna W Wilmink  2   13 , Jan H M Van Zundert  14   15 , Casper H van Eijck  16 , Marc G Besselink  1   2 , Markus W Hollmann  3 ; Dutch Pancreatic Cancer Group; Dutch Pancreatitis Study Group
Affiliations
Clinical Trial

Intravenous Lidocaine for Refractory Pain in Patients With Pancreatic Ductal Adenocarcinoma and Chronic Pancreatitis: A Multicenter Prospective Nonrandomized Pilot Study

Simone Augustinus et al. Clin Transl Gastroenterol. .

Abstract

Introduction: Refractory pain is a major clinical problem in patients with pancreatic ductal adenocarcinoma (PDAC) and chronic pancreatitis (CP). New, effective therapies to reduce pain are urgently needed. Intravenous lidocaine is used in clinical practice in patients with PDAC and CP, but its efficacy has not been studied prospectively.

Methods: Multicenter prospective nonrandomized pilot study included patients with moderate or severe pain (Numeric Rating Scale ≥ 4) associated with PDAC or CP in 5 Dutch centers. An intravenous lidocaine bolus of 1.5 mg/kg was followed by continuous infusion at 1.5 mg/kg/hr. The dose was raised every 15 minutes until treatment response (up to a maximum 2 mg/kg/hr) and consecutively administered for 2 hours. Primary outcome was the mean difference in pain severity, preinfusion, and the first day after (Brief Pain Inventory [BPI] scale 1-10). A BPI decrease ≥1.3 points was considered clinically relevant.

Results: Overall, 30 patients were included, 19 with PDAC (63%) and 11 with CP (37%). The mean difference in BPI at day 1 was 1.1 (SD ± 1.3) points for patients with PDAC and 0.5 (SD ± 1.7) for patients with CP. A clinically relevant decrease in BPI on day 1 was reported in 9 of 29 patients (31%), and this response lasted up to 1 month. No serious complications were reported, and only 3 minor complications (vertigo, nausea, and tingling of mouth). Treatment with lidocaine did not impact quality of life.

Discussion: Intravenous lidocaine in patients with painful PDAC and CP did not show an overall clinically relevant reduction of pain. However, this pilot study shows that the treatment is feasible in this patient group and had a positive effect in a third of patients which lasted up to a month with only minor side effects. To prove or exclude the efficacy of intravenous lidocaine, the study should be performed in a study with a greater sample size and less heterogeneous patient group.

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Conflict of interest statement

Guarantor of the article: Marc G. Besselink, MD, PhD.

Specific author contributions: S.A., M.B., and C.vV. were involved in conception and design of the study, acquisition of data, analysis and interpretation of data, drafting and revising critically for important intellectual content of all versions of the article, and gave final approval of this version of the manuscript to be published. M.B., B.B., S.B., M.B., O.B., W.tH., J.K., H.vK., M.N., N.S., M.S., R.V., J.dV., J.W., and J.vZ. were involved in conception and design of the study, interpretation of data, revising critically for important intellectual content of all versions of the article, and gave final approval of this version of the manuscript to be published. C.vE., M.B., and M.W. were involved in conception and design of the study, acquisition of data, interpretation of data, drafting and revising critically for important intellectual content of all versions of the article, and gave final approval of this version of the manuscript to be published.

Financial support: This research was funded by unrestricted grants from Inspire2Live, Deltaplan Alvleesklierkanker (grant number: WOO 22-01).

Potential competing interests: None to report.

Data sharing statement: Data can be made available on reasonable request by contacting the corresponding author.

Figures

Figure 1.
Figure 1.
Lidocaine administration. *Evaluation is done every 15 minutes, but the increase in dose is decided by the treating clinician. Therefore, it can take more evaluations to get to 2.0 mg/hr, and exact times are not specified in this figure.
Figure 2.
Figure 2.
Trial profile.
Figure 3.
Figure 3.
Long-term effect on pain after lidocaine infusion in responders versus all patients. Numbers in the graph indicate the mean BPI pain severity scores at the different time points. Responders are patients with a clinically relevant reduction in pain severity (defined as Δ ≥ 1.3). Bold numbers in the table indicate a clinically relevant difference.
See this image and copyright information in PMC

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