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已发表论文
研究局部麻醉剂在经完全植入式静脉输液装置置入无损伤针时的有效应用时间
Authors Jiang G, Yang X, Yang L, Liu J, Yuan H , Jiang X
Received 6 September 2025
Accepted for publication 21 December 2025
Published 26 December 2025 Volume 2025:19 Pages 11779—11788
DOI https://doi.org/10.2147/DDDT.S565220
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Professor Tamer Ibrahim
Guowei Jiang,* Xiaolei Yang,* Liye Yang,* Jiajing Liu, Hongbin Yuan, Xin Jiang
Department of Anesthesiology, Shanghai Changzheng Hospital, Second Affiliated Hospital of Naval Medical University, Shanghai, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Hongbin Yuan, Department of Anesthesiology, Shanghai Changzheng Hospital, Second Affiliated Hospital of Naval Medical University, Shanghai, 200003, People’s Republic of China, Tel +86 21 81885822, Email jfjczyy@aliyun.com Xin Jiang, Department of Anesthesiology, Shanghai Changzheng Hospital, Second Affiliated Hospital of Naval Medical University, Shanghai, 200003, People’s Republic of China, Tel +86 21 81885826, Email drxjiang@126.com
Purpose: This study aims to ascertain the median effective time (ET50) and the 95% effective time (ET95) of EMLA cream and tetracaine hydrochloride gel for analgesia during non-coring needle insertion into totally implantable venous access devices (TIVADs).
Patients and Methods: Participants were randomly assigned to either Group E, receiving 2g of EMLA cream, or Group T, receiving 1g of tetracaine hydrochloride gel. Prior to needle insertion, the topical anesthetic was uniformly applied to a 1 cm radius around the puncture site. The initial target application time was set at 60 minutes for Group E and 30 minutes for Group T. For each subsequent participant, the target time was adjusted using a 1:1.1-time gradient, based on the Numeric Rating Scale (NRS) score of the preceding participant. Baseline characteristics, NRS scores, and adverse reactions were documented by a researcher who was not involved in the needle insertion process. The probit analysis method was employed to determine the ET50 and ET95 values.
Results: The ET50 and ET95 of patients to achieve painless non-coring needle insertion with EMLA cream were 55.882 minutes (95% Confidence Interval [CI]: 51.369– 59.935 minutes) and 63.587 minutes (95% CI: 59.684– 92.592 minutes), respectively. In comparison, the ET50 and ET95 for tetracaine hydrochloride gel were 39.092 minutes (95% CI: 36.646– 41.678 minutes) and 43.388 minutes (95% CI: 41.111– 56.859 minutes), respectively. There was no statistically significant difference between the two groups regarding the incidence of mild and serious adverse reactions.
Conclusion: Application of EMLA cream for 64 minutes or tetracaine gel for 44 minutes at the site of TIVADs resulted in a safely conducted, painless non-coring needle puncture for 95% of patients.
Plain Language Summary: While totally implantable venous access ports (TIVADs) have significantly improved the comfort and safety of infusion therapy for cancer patients, patients still commonly experience pain from non-coring needle insertion prior to treatment. Topical anesthesia with local anesthetics can effectively reduce this puncture-related pain, yet the optimal application time remains undetermined. In this study, the researchers applied EMLA cream and tetracaine gel were applied to alleviate such pain. Using the up-and-down method and probit analysis, they estimated the median effective time (ET50) and the 95% effective time (ET95) for both anesthetics. The results show that 95% of patients had a safe, painless port needle puncture using either EMLA cream for 64 minutes or tetracaine gel for 44 minutes.
Keywords: lidocaine and prilocaine cream, tetracaine hydrochloride gel, topical anesthesia, effective time, PORT
Department of Anesthesiology, Shanghai Changzheng Hospital, Second Affiliated Hospital of Naval Medical University, Shanghai, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Hongbin Yuan, Department of Anesthesiology, Shanghai Changzheng Hospital, Second Affiliated Hospital of Naval Medical University, Shanghai, 200003, People’s Republic of China, Tel +86 21 81885822, Email jfjczyy@aliyun.com Xin Jiang, Department of Anesthesiology, Shanghai Changzheng Hospital, Second Affiliated Hospital of Naval Medical University, Shanghai, 200003, People’s Republic of China, Tel +86 21 81885826, Email drxjiang@126.com
Purpose: This study aims to ascertain the median effective time (ET50) and the 95% effective time (ET95) of EMLA cream and tetracaine hydrochloride gel for analgesia during non-coring needle insertion into totally implantable venous access devices (TIVADs).
Patients and Methods: Participants were randomly assigned to either Group E, receiving 2g of EMLA cream, or Group T, receiving 1g of tetracaine hydrochloride gel. Prior to needle insertion, the topical anesthetic was uniformly applied to a 1 cm radius around the puncture site. The initial target application time was set at 60 minutes for Group E and 30 minutes for Group T. For each subsequent participant, the target time was adjusted using a 1:1.1-time gradient, based on the Numeric Rating Scale (NRS) score of the preceding participant. Baseline characteristics, NRS scores, and adverse reactions were documented by a researcher who was not involved in the needle insertion process. The probit analysis method was employed to determine the ET50 and ET95 values.
Results: The ET50 and ET95 of patients to achieve painless non-coring needle insertion with EMLA cream were 55.882 minutes (95% Confidence Interval [CI]: 51.369– 59.935 minutes) and 63.587 minutes (95% CI: 59.684– 92.592 minutes), respectively. In comparison, the ET50 and ET95 for tetracaine hydrochloride gel were 39.092 minutes (95% CI: 36.646– 41.678 minutes) and 43.388 minutes (95% CI: 41.111– 56.859 minutes), respectively. There was no statistically significant difference between the two groups regarding the incidence of mild and serious adverse reactions.
Conclusion: Application of EMLA cream for 64 minutes or tetracaine gel for 44 minutes at the site of TIVADs resulted in a safely conducted, painless non-coring needle puncture for 95% of patients.
Plain Language Summary: While totally implantable venous access ports (TIVADs) have significantly improved the comfort and safety of infusion therapy for cancer patients, patients still commonly experience pain from non-coring needle insertion prior to treatment. Topical anesthesia with local anesthetics can effectively reduce this puncture-related pain, yet the optimal application time remains undetermined. In this study, the researchers applied EMLA cream and tetracaine gel were applied to alleviate such pain. Using the up-and-down method and probit analysis, they estimated the median effective time (ET50) and the 95% effective time (ET95) for both anesthetics. The results show that 95% of patients had a safe, painless port needle puncture using either EMLA cream for 64 minutes or tetracaine gel for 44 minutes.
Keywords: lidocaine and prilocaine cream, tetracaine hydrochloride gel, topical anesthesia, effective time, PORT