A Phase 4 interventional study of Ropivacaine 0.2% Injectable Solution and 0.9%sodium chloride in Knee Osteoarthritis, Knee Arthritis and Knee Arthropathy, sponsored by Poznan University of Medical Sciences. Completed at 1 site in Poland. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-10-17.
Sponsored by Poznan University of Medical Sciences · Phase 4, Interventional, and Treatment
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.
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.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's enrollment of 361 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Poznan University of Medical Sciences is the lead sponsor of 147 studies on the registry; 45 are open to participants now.
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Exclusion Criteria:
Patients received a preoperative ultrasound-guided iPACK block with 20 mL of 0.25% ropivacaine and an Adductor Canal block with 20mL 0.25% ropivacaine.
Drug: Ropivacaine 0.2% Injectable Solution
Patients received a preoperative ultrasound-guided iPACK block with 20 mL of 0.9% normal saline and an Adductor Canal block with 20mL 0.9% normal saline.
Drug: 0.9%sodium chloride
20 mL 0.5% ropivacaine was injected into the PENG block 20 mL 0.5% ropivacaine was injected into the Adductor Canal block
Also known as: Ropimol
20 mL 0.9% sodium chloride was injected into the PENG block 20 mL 0.5% sodium chloride was injected into the Adductor Canal block
Also known as: normal saline
postoperative Numeric Pain Rating Scale
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time frame: 24 hours after surgery
postoperative Numeric Pain Rating Scale et rest
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time frame: 48 hours after surgery
postoperative Numeric Pain Rating Scale et rest
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time frame: 72 hours after surgery
postoperative Numeric Pain Rating Scale et rest
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time frame: 96 hours after surgery
postoperative Numeric Pain Rating Scale during active flexion
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time frame: 48 hours after surgery
postoperative Numeric Pain Rating Scale during active flexion
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time frame: 72 hours after surgery
postoperative Numeric Pain Rating Scale during active flexion
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time frame: 96 hours after surgery
Postoperative opioid consumption
milligrams of intravenous morphine equivalents
Time frame: 96 hours after surgery
Neutrophil-to-lymphocyte ratio
Neutrophil-to-lymphocyte ratio
Time frame: 12 hours after surgery
Neutrophil-to-lymphocyte ratio
Neutrophil-to-lymphocyte ratio
Time frame: 24 hours after surgery
Platelet-to-lymphocyte ratio
Platelet-to-lymphocyte ratio
Time frame: 12 hours after surgery
Platelet-to-lymphocyte ratio
Platelet-to-lymphocyte ratio
Time frame: 24 hours after surgery
Time to first opioid administration
Hours to first administration of an intravenous opioid drug
Time frame: 96 hours postoperatively
Plan to share: Yes — The data presented in this study are available on request from the corresponding author.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: December 2024
Access criteria: The data presented in this study are available on request from the corresponding author.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ropivacaine · Sodium Chloride
Poznan University of Medical Sciences →