RecruitingNot ApplicableNCT07123805

ACU_Knee: Role of Acupuncture in Knee Prosthetic Surgery

ACU_Knee - Role of Acupuncture in Knee Prosthetic Surgery: Analgesia, Functional Outcome and Inflammatory Markers


Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Enrollment

80 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria5

  • Patients aged \> 18 years
  • Patients capable of providing informed consent
  • Unilateral total knee replacement surgery
  • Indication for surgery: primary osteoarthritis degeneration
  • Surgery performed electively

Exclusion Criteria14

  • Patients aged \< 18 years
  • Patients incapable of providing informed consent
  • Patients with ASA class \> 3
  • Pregnant women
  • Patients with rheumatoid arthritis or other autoimmune disorders
  • Patients with active infection under antibiotic treatment
  • Patients on chronic opioid therapy
  • Patients on chronic biological drug therapy
  • Patients with a history of corticosteroid use in the six months prior to surgery
  • Patients with a history of periarticular infiltration in the three months prior to surgery
  • Patients in whom loco-regional anesthesia is contraindicated
  • Patients in whom NSAID, cortisone, and paracetamol therapy is contraindicated
  • Bilateral total knee replacement surgery or prosthetic revision surgeries
  • Indication for surgery for causes other than primary osteoarthritis degeneration

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Interventions

DEVICEAcupuncture group

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.


Locations(1)

Fondazione IRCCS Policlinico San Matteo - SC AR3 - Anestesia e Terapia Intensiva Postchirurgica

Pavia, Pavia, Italy

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NCT07123805


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