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The effect of the iPACK block on pain and knee function in knee flexion deformity patients after primary TKA: a double-blinded, prospective, randomized controlled triala

The effect of the iPACK block on pain in knee flexion deformity patients after primary TKA: a double-blinded, prospective, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035179
Enrollment
Unknown
Registered
2020-08-02
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

knee osteoarthritis/ knee rheumatoid arthritis

Interventions

IPACK group:infiltration of 20 ml ropivacaine 0.25% between the interspace between the popliteal artery and capsule of the knee
control group:infiltration of 20ml 0.9% salinebetween the interspace between the popliteal artery and capsule of the knee

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) The patients who had flexion deformity of knee who underwent TKA(aged over 18 years); (2) Normal platelet and coagulation function preoperatively; (3) Normal intravenous ultrasound in the lower extremities preoperatively; (4) American Society of Anesthesiologists Physical Status classification I-III. (5) To be able to and willing to provide signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Contraindication to regional anesthesia or peripheral nerve blocks, allergy to local an- esthetics, allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (2) chronic renal insufficiency (Cr > 1.4 mg/dL or glomerular filtration rate 3 months) (4) pre-existing peripheral neuropathy involving the operative site (5) body mass index >40 kg/m2. (6) Systemic infections such as pulmonary infection or urinary tract infection are not controlled preoperatively; (7) Abnormal immune function or combined immune-related disease preoperatively; (8) Abnormal inflammatory index preoperatively (C-reactive protein > 20 mg/L); (9) Abnormal fibrinolysis index preoperatively (FDP > 5mg/L); (10) Discontinuation of oral anticoagulants or aspirin less than 1 week; (11) Allergy to tranexamic acid (TXA) or dexamethasone or have contraindications; (12) Patients at high risk of thrombosis; (13) History of deep vein thrombosis (VTE, calf muscle vein thrombosis or superficial vein thrombosis, pulmonary embolism); (14) Serious liver and kidney dysfunction.

Design outcomes

Primary

MeasureTime frame
VAS pain score;Morphine consumption;Time for First Analgesic Request;

Secondary

MeasureTime frame
Quadriceps muscle strength;Walking distance;Range of motion;PONV;color Doppler Ultrasonic (CDU) examination in lower extremity;SF-12;Satisfaction scores;Sleep quality;Opioid-Related Adverse Effects;Ambulation time;KSS;

Countries

China

Contacts

Public ContactZongke Zhou

West China Hospital, Sichuan University

zhouzongke@scu.edu.cn+86 18980601028

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026