ACU_Knee: Role of Acupuncture in Knee Prosthetic Surgery

NCT07123805 | Recruiting DMC

• 1 other identifier: ACU_Knee
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acupuncture Analgesia; Acupuncture; Acupuncture Therapy; Total Knee Anthroplasty; Postoperative Pain Management; Pain Threshold; Shoulder Pain; Laparoscopies; Acupuncture Ear

Keywords

acupuncture; total knee arthroplasty; pain

Outcome Measures

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

  48-96 hours

Secondary Outcomes (1)

• Time to first dose

  one, three, six, and twelve months

Other Outcomes (9)

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

  One, three, six, and twelve months

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

  One, three, six, and twelve months

• Patient's sleep quality

  One, three, six, and twelve months

Study Arms (2)

Standard group

NO INTERVENTION

the anesthesiological treatment will be the one routinely used at our UOC: mild sedation with midazolam 1-2mg ev LRA subarachnoid with Levobupivacaine 0.5% 10-12mg tranexamic acid 1g ev. dexamethasone 4mg ev pre-operative analgesic block of the saphenous nerve with L-bupivacaine 0.5% 15ml, ultrasound-guided technique: pre-operative iPACK Block (Interspace between the Popliteal Artery and Capsule of the Knee) with L-bupivacaine 0.375% 20ml, ultrasound-guided technique; intraoperative analgesic therapy: Ketorolac 15mg + Paracetamol 1000mg ev post-operative analgesic therapy: paracetamol 1000mg ev every 8 hours; ibuprofen 400mg cp every 8 hours; tapentadol 50mg cp every 12 hours; rescue therapy (to be administered in case of NRS \> 4): Oxycodone + Paracetamol 5/325mg, 1cp every 30 minutes, for a maximum of 4cp/day.

Acupuncture group

ACTIVE COMPARATOR

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.

Device: Acupuncture group

Interventions

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.

Acupuncture group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

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

Pavia, Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Shoulder Pain; Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Debora Passador, MD

CONTACT

+390382502767; d.passador@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: August 14, 2025
• Study Start: April 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-02

Locations

IT (1)