529: A Clinical Trial on Analgesic Efficacy of Amitriptyline Spray

Topic: Clinical Science
Subtopic: Pain category (ICD-11), Chronic neuropathic pain, Developing methodology/technology

Background and Aims: This study aimed to evaluate the effectiveness, safety, and patient acceptability of topical amitriptyline spray（Amitriptyline spray has obtained invention patent certification, and this research project has received funding from the Chinese government.） for managing acute herpes zoster-related pain through a clinical trial.

Methods: In this randomized, double-blind, placebo-controlled trial, 206 patients diagnosed with acute herpes zoster pain were randomly assigned to either the amitriptyline spray group or the placebo group. The primary outcome was pain score within1/2h and 2 hours post-application. Secondary outcomes included 24hour analgesic satisfaction, consumption of secondary analgesics, and incidence of adverse events.

Results: The amitriptyline spray group showed significantly greater pain reduction at 30 minutes (3.68 ± 0.98 vs. 1.35 ± 1.17; P < 0.001) and 2 hours (3.12 ± 0.73 vs. 1.01 ± 0.95; P < 0.001) compared to the placebo group. Pain scores in the amitriptyline group remained significantly lower from day 1 to day 7 of hospitalization (P < 0.001).The spray group also required fewer secondary analgesics over 24 hours versus placebo group (P < 0.001). Patient satisfaction with analgesia was 87.4%[ 95%CI, 85.4%–88.5%].

Conclusions: Topical amitriptyline spray demonstrated direct analgesic effects, high patient satisfaction, and excellent acceptability. No oral amitriptyline-associated adverse effects or new safety concerns were observed during the trial.

References: [1] Finnerup NB, Kuner R, Jensen TS. Neuropathic Pain: From Mechanisms to Treatment. Physiol Rev. 2021 Jan1;101(1):259-301.[2] Huang Y, Chen H, Chen SR, Pan HL. Duloxetine and Amitriptyline Reduce Neuropathic Pain by Inhibiting Primary Sensory Input to Spinal Dorsal Horn Neurons via α1- and α2-Adrenergic Receptors. ACS Chem Neurosci. 2023 Apr5;14(7):1261-1277.[3] Ho KY, Huh BK, White WD, Yeh CC, Miller EJ. Topical amitriptyline versus lidocaine in the treatment of neuropathic pain. Clin J Pain. 2008 Jan;24(1):51-5.

Presenting Author: jinyu lai
Submitting Author: jinyu lai

Senior Author: yulan li

IASP 2026 Global Year theme of Neuropathic Pain: Yes

• yulan li: M.D., Ph.D. - Department of Anesthesiology, The First Hospital of Lanzhou University, Lanzhou, China.
• yong xiang: M.D., Ph.D. - Department of Pain ,Taihe Hospital, Hubei University of Medicine, Hubei, China