Background: Postherpetic neuralgia (PHN) is pain that persists for 1 month or more after the shingles rash has healed, the incidence of which increases with age. Some patients with PHN will experience breakthrough pain (BTP), which is unpredictable and severe in intensity, and seriously affects patients' life quality and treatment compliance. The current clinical rescue programs are lagging behind and the effect is poor. Therefore, it has become an urgent clinical problem and research hotspot to explore timely and efficient treatment options for PHN patients with breakthrough pain. Oxycodone is widely used in the treatment of moderate to severe acute and chronic pain and cancer pain. In previous studies of cancer pain, oxycodone was found to have similar efficacy as morphine, with fewer adverse effects than morphine. The efficacy and adverse reactions of oxycodone in PHN with breakthrough pain have not been reported before. This trial intends to set up a study, using morphine as a reference, to explore the efficacy and safety of oxycodone in PHN patients with breakthrough pain, with the aim of exploring the best treatment option for patients with refractory PHN episodic pain.
Methods: This study is a prospective, double-blind, randomized controlled clinical trial involving 84 PHN patients with breakthrough pain (number of outbreaks ≥ 3 times/day, NRS score ≥ 7) hospitalized in the Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. At the onset of painful outbreaks, rescue medication such as morphine patient controlled intravenous analgesia (PCIA) and equal amount of oxycodone PCIA will be given. The change in NRS score before and after the administration of the drugs and the effective rate of pain control will be evaluated to assess the efficacy and safety of the different regimens.
Discussion: We innovatively use oxycodone PCIA for the control of PHN episode pain, in order to shorten the duration of hospitalization and accelerate the recovery of patients. We hope to contribute our wisdom to the clinical problems that the current recue treatment of PHN breakthrough pain has significant lag and poor effect.
Trial registration number ChiCTR2200065358