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Comparison of a four-nerve block protocol versus adductor canal block plus local infiltration analgesia for primary total knee arthroplasty in two French private hospitals: protocol for the multicentre randomised INCA trial

Por: Elmaleh · Y. · Maupain · O. · Guessous · K. · Kattou · F. · Laurent · R. · Giral · T. · Garnier · T. · Delvaux · B.
Background

INCA is a multicentre, prospective, randomised, two-arm superiority trial. 100 adult patients scheduled for primary total knee arthroplasty (TKA) will be randomised 1:1 to one of two locoregional analgesia strategies: group 1 (standard strategy), single-shot adductor canal block (ACB) combined with active surgeon-administered peri-articular infiltration with ropivacaine and participant-facing sham peripheral nerve blocks; group 2 (four-nerve block strategy), single-shot ACB combined with three additional ultrasound-guided nerve blocks (lateral femoral cutaneous, obturator and infiltration between the popliteal artery and capsule of the knee (IPACK) blocks) plus sham surgical infiltration. All patients will receive general anaesthesia and identical systemic multimodal analgesia (paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), nefopam and rescue opioids) so that any between-group differences can be attributed to the allocated regional strategy. The primary outcome is global recovery at 24 hours, assessed by the Quality of Recovery-15 (QoR-15) questionnaire. Secondary outcomes include postoperative pain scores, opioid consumption, rescue analgesia including any rescue infiltration, motor function and adverse events, range of motion of the index knee, time to first ambulation, postanaesthesia care unit (PACU) stay, hospital length of stay, QoR-15 at 48 hours and Knee Injury and Osteoarthritis Outcome Score-Joint Replacement (KOOS-JR) at 1 month.

Methods

INCA is a multicentre, prospective, randomised two-arm superiority trial. 100 adult patients scheduled for primary TKA will be randomised 1:1 to one of two locoregional analgesia strategies: group 1 (standard strategy), single-shot ACB combined with surgeon-administered peri-articular infiltration; group 2 (four-nerve block strategy), single-shot ACB combined with three additional ultrasound-guided nerve blocks (lateral femoral cutaneous, obturator and IPACK blocks) without active infiltration. Participant-facing sham procedures will be used to preserve blinding. All patients will receive general anaesthesia and identical systemic multimodal analgesia (paracetamol, NSAIDs, nefopam and rescue opioids) so that any between-group differences can be attributed to the regional strategy. The primary outcome is global recovery at 24 hours, assessed by the QoR-15 questionnaire. Secondary outcomes include postoperative pain scores, opioid consumption, rescue analgesia including any rescue infiltration, motor function and adverse events, range of motion of the index knee, time to first ambulation, PACU stay, hospital length of stay, QoR-15 at 48 hours and KOOS-JR at 1 month.

Ethics and dissemination

The study protocol has been approved by the regional ethics committee (Comité de Protection des Personnes). All participants provide written informed consent. The trial will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Study results will be disseminated to participants and submitted for publication in a peer-reviewed journal and presented at national and international conferences to inform best practices in TKA analgesia.

Trial registration number

NCT06920186.

Version 4.0 (11 February 2025).

Values and preferences of patients with severe mental illness regarding smoking cessation interventions: a systematic review with best-fit framework synthesis

Por: Coteur · K. · Tops · L. · Bekkering · G. E. · de Almeida Ferreira Fonseca · L. · van den Brand · F. · Cloetens · H. · Zeng · L. · Aertgeerts · B. · Delvaux · N. · Agarwal · A. · Agoritsas · T. · Vermandere · M.
Objective

To identify values and preferences regarding smoking cessation interventions among adults with severe mental illness

Design

Systematic review with best-fit framework synthesis

Data sources

MEDLINE, EMBASE, Web of Science, CINAHL and Scopus from inception to 14 November 2025.

Study selection

Studies with any design, in any clinical and geographical setting, reporting on adult (18+) current or past smokers with a diagnosis of schizophrenia, bipolar or mood disorder, including major depressive disorder or post-traumatic stress disorder. We selected all quantitative and qualitative findings regarding patients’ values and preferences, including beliefs, attitudes, behaviours and perceived barriers and facilitators, in relation to smoking cessation interventions.

Data extraction and synthesis

Two reviewers independently screened studies. After a pilot to increase accuracy, data were extracted by one reviewer and verified by another. Risk of bias was assessed using the Mixed Methods Appraisal Tool. We used the best-fit framework synthesis methodology to synthesise the data.

Results

Of 14 970 identified articles, 65 were included. Most studies were of moderate to high quality. Financial costs posed a significant barrier, while education and social support emerged as important facilitators. Patients preferred personal interactions with healthcare providers. Their motivation for cessation varied and was influenced by habits and perceived nicotine dependence. Health concerns and financial savings were primary drivers for reflective motivation. Beliefs regarding treatment varied. Although commonly used, scepticism about nicotine replacement therapy and concerns about the long-term safety of electronic delivery systems were reported. Overall, patients preferred personalised, flexible programmes and emphasised the need for tailored approaches. Digital interventions, especially mobile apps, that provide support, motivational content and relevant information, were perceived as appealing and helpful when sufficiently considering accessibility and usability aspects. Patients commonly perceived smoking as a coping mechanism for negative emotions. Developing new coping strategies and creating smoke-free environments were deemed to contribute to successful cessation.

Conclusions

Patient-centred care for people with severe mental illness should leverage behavioural and pharmacological strategies for smoking cessation. Flexibility, accessibility and ongoing support appeared important for addressing stress, withdrawal symptom interpretation and relapse vulnerability in this population.

PROSPERO registration number

CRD42022337933.

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