Clinical trial NCT06086483: Pain Management After Adductor Canal Block for Total Knee Arthroplasty
Official title: Pain Management and Functional Recovery After Adductor Canal Block Combined With iPACK Block for Total Knee Arthroplasty. A Prospective, Randomized, Double-blinded Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Knee Arthritis
Knee Arthropathy
Knee Pain Chronic
Keywords: iPACK
Adductor Canal Block
pain management
multimodal analgesia
peripheral nerve block
knee arthroplasty
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, placebo-controlled
Primary purpose: TREATMENT

Brief summary: This randomized, double-blinded, placebo-controlled trial sought to evaluate the efficacy of the iPACK block with Adductor Canal Block on postoperative pain, functional recovery and NLR and PLR levels.

Detailed description: The Interspace between the popliteal artery and capsule of the posterior knee, or iPACK block, together with the Adductor Canal block (ACB), has been described and shows promise in providing analgesia to the knee joint. However, the effect of these two blocks on postoperative pain levels, functional recovery, and stress response is uncertain. This study compares a preoperative iPACK and ACB block to Sham blocks before total knee arthroplasty under spinal anesthesia.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years old undergoing unilateral total knee arthroplasty

Exclusion Criteria:

* refusal to participate
* \< 18 yo
* Chronic opioid use
* localized infection

Primary outcomes:
measure: postoperative Numeric Pain Rating Scale
timeFrame: 24 hours after surgery
measure: postoperative Numeric Pain Rating Scale et rest
timeFrame: 48 hours after surgery
measure: postoperative Numeric Pain Rating Scale et rest
timeFrame: 72 hours after surgery
measure: postoperative Numeric Pain Rating Scale et rest
timeFrame: 96 hours after surgery
measure: postoperative Numeric Pain Rating Scale during active flexion
timeFrame: 48 hours after surgery
measure: postoperative Numeric Pain Rating Scale during active flexion
timeFrame: 72 hours after surgery
measure: postoperative Numeric Pain Rating Scale during active flexion
timeFrame: 96 hours after surgery
Secondary outcomes:
measure: Postoperative opioid consumption
timeFrame: 96 hours after surgery
measure: Neutrophil-to-lymphocyte ratio
timeFrame: 12 hours after surgery
measure: Neutrophil-to-lymphocyte ratio
timeFrame: 24 hours after surgery
measure: Platelet-to-lymphocyte ratio
timeFrame: 12 hours after surgery
measure: Platelet-to-lymphocyte ratio
timeFrame: 24 hours after surgery
measure: Time to first opioid administration
timeFrame: 96 hours postoperatively
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
state: Poznań
Study officials:
affiliation: Department of Emergency Medicine Clinic
name: Zbigniew Żaba, Ph.D.
role: STUDY_CHAIR
affiliation: Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland
name: Malgorzata Domagalska, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: