Pain research & management · 2026
Effectiveness and Safety of a Novel Catheter-Over-Needle Assembly for Postoperative Analgesia in Orthopedic Limb Surgery: A Multicenter, Randomized, Single-Blind, Active-Controlled Noninferiority Trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Yu Bin, Fang Hao, Chang Tao, Fu Shukun, Xie Shuqi, Zhao Zitong, Zhang Nu, Zhao Hongcheng, Cao Xiaodan, Shen Xiyuan
Аннотация
PURPOSE: Indwelling nerve catheters are commonly used for postoperative analgesia following limb fracture surgeries. This multicenter, randomized, single-blind, active-controlled parallel trial aimed to compare the novel Tuoren catheter-over-needle assembly with the Contiplex D catheter-through-needle assembly for postoperative pain management.
METHODS: The trial was conducted at three centers in China. Patients undergoing elective limb fracture surgery were randomly assigned (1:1) to either the Tuoren group or the Contiplex D group for postoperative analgesia. The primary outcome was the noninferiority of the Tuoren assembly compared to that of the Contiplex D assembly in terms of the 24-h postoperative analgesia effectiveness rate. Secondary outcomes were patient and surgeon satisfaction, safety, and the time required for puncture and catheter insertion. The rate of local anesthetic leakage and the incidence of catheter kinking and dislodgement during analgesia were also evaluated.
RESULTS: Between June 2019 and June 2021, 232 patients were randomized. The 24-h postoperative analgesia effectiveness rate was 99.1% in both groups. After adjusting for surgery types and centers, the difference was 0.06% [-2.36%, 2.49%] with a 95% CI. The lower boundary was above the noninferiority limit of -10%. The insertion time for the Tuoren assembly was significantly shorter compared to that of the Contiplex D assembly. Other outcomes did not show statistical differences.
CONCLUSIONS: The novel Tuoren assembly was noninferior to the Contiplex D catheter-through-needle assembly in terms of analgesic effectiveness and safety.
TRIAL REGISTRATION: Chinese Registry of Clinical Trials: ChiCTR1900022980.
METHODS: The trial was conducted at three centers in China. Patients undergoing elective limb fracture surgery were randomly assigned (1:1) to either the Tuoren group or the Contiplex D group for postoperative analgesia. The primary outcome was the noninferiority of the Tuoren assembly compared to that of the Contiplex D assembly in terms of the 24-h postoperative analgesia effectiveness rate. Secondary outcomes were patient and surgeon satisfaction, safety, and the time required for puncture and catheter insertion. The rate of local anesthetic leakage and the incidence of catheter kinking and dislodgement during analgesia were also evaluated.
RESULTS: Between June 2019 and June 2021, 232 patients were randomized. The 24-h postoperative analgesia effectiveness rate was 99.1% in both groups. After adjusting for surgery types and centers, the difference was 0.06% [-2.36%, 2.49%] with a 95% CI. The lower boundary was above the noninferiority limit of -10%. The insertion time for the Tuoren assembly was significantly shorter compared to that of the Contiplex D assembly. Other outcomes did not show statistical differences.
CONCLUSIONS: The novel Tuoren assembly was noninferior to the Contiplex D catheter-through-needle assembly in terms of analgesic effectiveness and safety.
TRIAL REGISTRATION: Chinese Registry of Clinical Trials: ChiCTR1900022980.