PurposePatients with the placement of a totally implantable venous access port (TIVAP) commonly suffer from pain caused by inserting a non-coring needle. At present, lidocaine cream and cold spray are extensively used for pain management, but they are complex to manage in busy medical environments and developing countries. The lidocaine spray combines the analgesic effect of lidocaine cream and the rapid onset of cold spray, which can effectively alleviate the pain related to non-coring needle puncture in patients with TIVAP. This randomized-controlled trial aimed to explore the effectiveness, acceptability, and safety of lidocaine spray in relieving the pain of non-coring needle puncture in patients with TIVAP.MethodsA total of 84 patients who were hospitalized in the oncology department of a Grade III Level-A hospital in Shanghai from January 2023 to March 2023 and were implanted with TIVAP and required non-coring needle puncture were selected as the study subjects. The recruited patients were randomly assigned to the intervention group and the control group (n=42). Before routine maintenance, the intervention group received lidocaine spray 5 min before disinfection, while the control group received water spray 5 min before disinfection. The main clinical outcome was pain, and the degree of puncture pain in both groups was evaluated using the visual analogue scale.ResultsThere were no significant differences between the two groups in age, gender, educational level, body mass index, port implantation time, and disease diagnosis (P>0.05). The pain score in the intervention and control groups was 15.12±6.61mm and 36.50±18.79mm, respectively (P<0.001). There were 2 (4.8%) patients with moderate pain in the intervention group and 18 (42.9%) patients with moderate pain in the control group (P<0.001). In the control group, 3 (7.1%) patients reported severe pain. The median comfortability score for the two groups of patients was 10, but there was a difference between the two groups (P<0.05) because the intervention group tilted to the right. The successful puncture rate of the first time puncture had no difference between the two groups, both being 100%. Moreover, 33 patients (78.6%) in the intervention group and 12 patients (28.6%) in the control group reported that they would choose the same spray for intervention in the future (P<0.001). During the 1 week of follow-up, 1 patient in the intervention group developed skin itching (P>0.05).ConclusionsThe local use of lidocaine spray in patients with TIVAP is effective, acceptable, and safe to alleviate the pain caused by non-coring needle puncture.Trial registrationChinese Clinical Trial Registry (registration number: ChiCTR2300072976)