Evidence map›Paper›PMID 42057491›Full record

Trial reportPain research & management2026

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.

Bin Yu, Hao Fang, Tao Chang, Shukun Fu, Shuqi Xie, Zitong Zhao, Nu Zhang, Hongcheng Zhao, Xiaodan Cao, Xiyuan Shen

Abstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pain research & management, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Bin YuDepartment of Anesthesiology and Pain Rehabilitation, Cardiopulmonary and Critical Care Rehabilitation Center, Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center), School of Medicine, Tongji University, Shanghai, China, tongji.edu.cn.ORCID https://orcid.org/0000-0002-7218-7535
Hao FangDepartment of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, China, fudan.edu.cn.ORCID https://orcid.org/0000-0003-1547-6135
Tao ChangDepartment of Anesthesiology, Tenth People's Hospital of Tongji University, Shanghai, China, shdsyy.com.cn.ORCID https://orcid.org/0009-0002-0437-9313
Shukun FuDepartment of Anesthesiology, Tenth People's Hospital of Tongji University, Shanghai, China, shdsyy.com.cn.ORCID https://orcid.org/0009-0008-7812-8879
Shuqi XieDepartment of Anesthesiology, Shanghai Tongji Hospital, School of Medicine, Tongji University, Shanghai, China, tongji.edu.cn.ORCID https://orcid.org/0009-0001-7146-6161
Zitong ZhaoDepartment of Anesthesiology and Pain Rehabilitation, Cardiopulmonary and Critical Care Rehabilitation Center, Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center), School of Medicine, Tongji University, Shanghai, China, tongji.edu.cn.ORCID https://orcid.org/0000-0002-9143-2268
Nu ZhangDepartment of Anesthesiology, Minhang Hospital, Fudan University, Shanghai, China, fudan.edu.cn.ORCID https://orcid.org/0009-0005-9191-8558
Hongcheng ZhaoDepartment of Anesthesiology, Tenth People's Hospital of Tongji University, Shanghai, China, shdsyy.com.cn.ORCID https://orcid.org/0009-0004-8798-7553
Xiaodan CaoDepartment of Anesthesiology, Shanghai Tongji Hospital, School of Medicine, Tongji University, Shanghai, China, tongji.edu.cn.ORCID https://orcid.org/0009-0001-8388-4010
Xiyuan ShenDepartment of Anesthesiology, Shanghai Tongji Hospital, School of Medicine, Tongji University, Shanghai, China, tongji.edu.cn.ORCID https://orcid.org/0009-0002-0043-2332

Funding

Henan Tuoren Medical Device Co., Ltd.National Natural Science Foundation of China 82471242Science and Technology Commission of Shanghai Municipality 23Y11906500Shanghai Research Center of Rehabilitation Medicine (Top Priority Research Center of Shanghai) 2023ZZ02027Shanghai Shenkang Hospital Development Center Municipal Hospital Diagnosis and Treatment Technology Promotion and Optimization Management Project SHDC12024147
6 · The paper itself

Abstract

purposeIndwelling 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.

methodsThe 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.

resultsBetween 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.

conclusionsThe novel Tuoren assembly was noninferior to the Contiplex D catheter-through-needle assembly in terms of analgesic effectiveness and safety.

trial registrationChinese Registry of Clinical Trials: ChiCTR1900022980.

Indexed as

Catheters, IndwellingNerve BlockOrthopedic ProceduresPostoperative PainAdultAgedAnesthetics, LocalExtremitiesFemaleHumansMaleMiddle AgedSingle-Blind MethodAnesthetics, Localcontinuous peripheral nerve block analgesiacontinuous peripheral nerve block assemblylimb fracture surgerynerve block catheterspostoperative analgesia

Identifiers

PMID42057491
PMCPMC13129405

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.