Evidence map›Paper›PMID 33785016›Full record

ArticleBMC musculoskeletal disorders2021

Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial.

Shicheng Wang, Wensheng Wang, Long Shao, Jing Ling

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC musculoskeletal disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 24% of its field
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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Observational
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

4 authors at 1 institution in 1 country.

Shicheng WangDepartment of Orthopaedic Surgery, Ningbo No.6 Hospital, 1059 Zhongshan East Road, Ningbo, 315040,, Zhejiang, China.
Wensheng WangDepartment of Neurology, Ningbo No.6 Hospital, 1059 Zhongshan East Road, Ningbo, 315040,, Zhejiang, China.
Long ShaoDepartment of Orthopaedic Surgery, Ningbo No.6 Hospital, 1059 Zhongshan East Road, Ningbo, 315040,, Zhejiang, China.
Jing LingDepartment of Orthopaedic Surgery, Ningbo No.6 Hospital, 1059 Zhongshan East Road, Ningbo, 315040,, Zhejiang, China. lingjing82@126.com.
Ningbo No.6 Hospital · CN

Funding

Ningbo Life Science and Technology City project 2019Y53
6 · The paper itself

Abstract

backgroundPostoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group.

methodsThis randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. DISCUSSION: This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals.

trial registrationChinese Clinical Trial Registry ( http://www.chictr.org.cn ) registration number: ChiCTR2000031674 . Registered 07 April 2020.

Indexed as

Arthroplasty, Replacement, KneeOsteoarthritis, KneeDuloxetine HydrochlorideHumansPostoperative PainRandomized Controlled Trials as TopicTreatment OutcomeDuloxetine HydrochlorideCentral sensitizationDuloxetinePainTotal knee arthroplasty

Identifiers

PMID33785016
PMCPMC8008334
OpenAlexW3143124021

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.