Knee Osteoarthritis Clinical Trial
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.
Verified date | October 2023 |
Source | Poznan University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 361 |
Est. completion date | August 24, 2023 |
Est. primary completion date | July 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Patients > 18 years old undergoing unilateral total knee arthroplasty Exclusion Criteria: - refusal to participate - < 18 yo - Chronic opioid use - localized infection |
Country | Name | City | State |
---|---|---|---|
Poland | Poznan University of Medical Sciences | Poznan | Poznan |
Lead Sponsor | Collaborator |
---|---|
Poznan University of Medical Sciences |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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") | 24 hours after surgery | |
Primary | 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") | 48 hours after surgery | |
Primary | 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") | 72 hours after surgery | |
Primary | 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") | 96 hours after surgery | |
Primary | 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") | 48 hours after surgery | |
Primary | 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") | 72 hours after surgery | |
Primary | 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") | 96 hours after surgery | |
Secondary | Postoperative opioid consumption | milligrams of intravenous morphine equivalents | 96 hours after surgery | |
Secondary | Neutrophil-to-lymphocyte ratio | Neutrophil-to-lymphocyte ratio | 12 hours after surgery | |
Secondary | Neutrophil-to-lymphocyte ratio | Neutrophil-to-lymphocyte ratio | 24 hours after surgery | |
Secondary | Platelet-to-lymphocyte ratio | Platelet-to-lymphocyte ratio | 12 hours after surgery | |
Secondary | Platelet-to-lymphocyte ratio | Platelet-to-lymphocyte ratio | 24 hours after surgery | |
Secondary | Time to first opioid administration | Hours to first administration of an intravenous opioid drug | 96 hours postoperatively |
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