ACU_Knee: Role of Acupuncture in Knee Prosthetic Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

Post-operative analgesia after total knee arthroplasty (TKA) has always been a challenge in the anesthesiological setting, having to combine good pain control and the need for early mobilization, both factors that can affect the quality of rehabilitation treatment, prosthetic functional outcome, the onset of chronic pain, joint stiffness and the consequent quality of life of the patient. Recent loco-regional anesthesia (LRA) techniques have made an essential contribution to peri-operative management in the fast-track perspective of surgery, in terms of optimization of analgesia and rapid functional recovery. Inadequate post-operative analgesia, by affecting the normal rehabilitation pathway, is associated with medium-long term complications, such as chronic pain, joint stiffness and patient dissatisfaction, which often compromise functional autonomy and quality of life of the patient and may require invasive treatments (surgical revision, unlocking under general anesthesia). The local and systemic inflammatory state, evidenced by peri-operative dosage of specific biomarkers, appears to be related to prosthetic outcome.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged > 18 years

Patients capable of providing informed consent

Unilateral total knee replacement surgery

Indication for surgery: primary osteoarthritis degeneration

Disqualifiers

Patients aged < 18 years

Patients incapable of providing informed consent

Patients with ASA class > 3

Pregnant women

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture group

    Device

    In the Acu group, acupuncture and auriculotherapy will be added to the standard treatment: patients will undergo three/four sessions of manual acupuncture lasting 20 minutes, the first in the immediate pre-operative period and the subsequent ones at a distance of 24, 48, 72 hours from surgery. The treatment includes manual acupuncture applied to specific points: LI4, LV3 and ST36 bilaterally and monolaterally SP6 and GB34, ipsilateral to the knee to be prostheticized. Furthermore, auricolar needles will be positioned, before surgery, for self-stimulation of the auriculotherapy points corresponding to Shen Men bilaterally and the knee point ipsilateral to the surgical side.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Standard groupNo intervention 0 interventions
Group B: Acupuncture groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quantity of opioid rescue medication taken by the patient

Number of tablets taken daily and overall between 48 and 96 hours post-surgery

Time frame
48-96 hours

Secondary outcomes

1

Time to first dose

Time between surgery and the first dose of rescue opioid

Time frame
one, three, six, and twelve months

Other outcomes

1

Appearance of side effects related to opioid use during the first 96 hours of hospitalization

Safety in terms of local tolerability in patients in the acupuncture treatment arm and systemic adverse events

Time frame
One, three, six, and twelve months
2

Pain perceived by the patient according to the NRS pain assessment scale at rest and dynamic

Time frame
One, three, six, and twelve months
3

Patient's sleep quality

Analysis of the relaxing effect and modulation on sleep quality during the first 96 hours of hospitalization using the Richards-Campbell Sleep Questionnaire

Time frame
One, three, six, and twelve months
4

Time out-of-bed

The variation in the time interval between surgery and the resumption of standing

Time frame
One, three, six, and twelve months

Sponsors and contacts

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