- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07267650
iPACK Block vs. Periarticular Infiltration for TKA Pain Control
Postoperative Analgesic Outcomes of iPACK Block Versus Periarticular Infiltration in Total Knee Arthroplasty: A Retrospective Cohort Study
This study aims to retrospectively compare two different multimodal analgesic techniques for pain management after total knee arthroplasty (TKA). The primary purpose is to evaluate whether a combination of two specific nerve blocks administered by an anesthesiologist (Femoral Triangle Block + iPACK block) resulted in superior postoperative pain control compared to a hybrid combination of a nerve block and a local infiltration administered by the surgeon (FTB + Periarticular Infiltration [PAI]).
The hypothesis is that the FTB + iPACK combination is associated with a significant reduction in Numeric Rating Scale (NRS) pain scores with movement at 24 hours postoperatively. This is a retrospective, observational cohort study conducted at a single center, involving medical records of patients who underwent primary unilateral TKA. Data from patients who received either FTB + iPACK or FTB + PAI as part of their standard clinical care will be extracted and analyzed retrospectively.
Study Overview
Status
Intervention / Treatment
Detailed Description
Total knee arthroplasty (TKA) is a highly successful procedure for end-stage knee osteoarthritis but is associated with significant postoperative pain. Effective pain management is crucial for facilitating early rehabilitation and improving patient comfort. Modern pain management relies on multimodal, opioid-sparing protocols that often include motor-sparing regional anesthesia techniques like the femoral triangle block (FTB).
While FTB provides excellent analgesia for the anterior part of the knee, pain originating from the posterior knee capsule remains a significant challenge. This posterior pain is commonly managed either by the surgeon through a diffuse periarticular infiltration (PAI) of a local anesthetic cocktail or by the anesthesiologist through a targeted, ultrasound-guided block of the posterior capsule known as the iPACK block.
It is currently unclear whether a fully anesthesiologist-driven, neuroanatomically targeted approach (FTB + iPACK) offers superior clinical outcomes compared to a hybrid approach involving both the anesthesiologist and the surgeon (FTB + PAI). This retrospective study is designed to compare the clinical efficacy of these two advanced analgesic combinations by reviewing institutional patient registries. All included patients had previously received a standardized spinal anesthetic (3 mL of 0.5% heavy bupivacaine) followed by either of the regional analgesia protocols. The study evaluates postoperative pain control, measured primarily by Numeric Rating Scale (NRS) pain scores at 24 hours. Secondary outcomes include total rescue analgesic (tramadol) consumption, functional recovery (Timed Up and Go test and Straight Leg Raise test), and knee range of motion.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Celil M Aslan, Medical Doctor
- Phone Number: +90505534900
- Email: mcaslan@outlook.com.tr
Study Locations
-
-
Manisa
-
Manisa, Manisa, Turkey (Türkiye), 45000
- Turgutlu State Hospital+
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status II-III.
- Scheduled for elective, primary, unilateral total knee arthroplasty for osteoarthritis.
- Able to provide written informed consent.
Exclusion Criteria:
- Patient refusal to participate or contraindication to regional anesthesia.
- Known allergy to any study medications (local anesthetics, NSAIDs, tramadol, morphine, paracetamol).
- History of chronic opioid use (defined as daily use for >3 months)
- Pre-existing peripheral neuropathy in the operative limb.
- Severe renal or hepatic insufficiency.
- Cognitive impairment preventing the use of pain scales or questionnaires.
- Revision or bilateral knee arthroplasty.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
FTB + iPACK Group
Patients who underwent primary unilateral TKA and received FTB + iPACK block as part of standard clinical care.
|
|
FTB + PAI Group
Patients who underwent primary unilateral TKA and received FTB + PAI as part of standard clinical care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Score with Movement at 24 Hours
Time Frame: 24 and 48. hours postoperatively
|
Pain assessed via Numeric Rating Scale (NRS) during active movement (e.g., active knee flexion or straight leg raise).
Scale: 0 (no pain) to 10 (worst pain imaginable).
|
24 and 48. hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Scores (Time-Course)
Time Frame: Assessed at 6, 12, and 24 hours postoperatively
|
Numeric Rating Scale (NRS) for pain (0-10) assessed at rest and with movement.
|
Assessed at 6, 12, and 24 hours postoperatively
|
|
Time Up to Go Test
Time Frame: Assessed at 24 hours
|
The time taken (in seconds) for the participant to stand up from a standard armchair, walk a distance of 3 meters, turn, walk back to the chair, and sit down.
Lower values indicate better functional mobility.
|
Assessed at 24 hours
|
|
Straight Leg Raise
Time Frame: Postoperative 24. hour
|
Assessment of active quadriceps motor function.
Defined as the participant's ability to actively lift the operated leg off the bed with the knee fully extended (straight).
This will be assessed as a binary outcome (Success = Able to lift unassisted / Failure = Unable to lift).
|
Postoperative 24. hour
|
|
Knee Range of Motion (ROM)
Time Frame: Baseline (Preoperative) and 24 hours postoperatively
|
Active knee flexion (in degrees)
|
Baseline (Preoperative) and 24 hours postoperatively
|
|
Time to First Rescue Analgesia
Time Frame: First 24 postoperative hours
|
Time (in minutes) from the end of surgery to the first patient request for rescue tramadol.
|
First 24 postoperative hours
|
|
Incidence of Adverse Events
Time Frame: First 48 hours.
|
Incidence of postoperative nausea/vomiting (PONV) and pruritus.
|
First 48 hours.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aslan, Turgutlu State Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Postoperative Complications
- Pathologic Processes
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Osteoarthritis
- Agnosia
- Sulfur Compounds
- Organic Chemicals
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Pharmaceutical Preparations
- Hydrocarbons
- Hydrocarbons, Cyclic
- Hydrocarbons, Aromatic
- Polycyclic Compounds
- Anilides
- Amides
- Aniline Compounds
- Amines
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Health Care Facilities Workforce and Services
- Catechols
- Phenols
- Benzene Derivatives
- Crystalloid Solutions
- Isotonic Solutions
- Solutions
- Physicians
- Health Personnel
- Alcohols
- Pregnadienetriols
- Amino Alcohols
- Ethanolamines
- beta-Lactams
- Lactams
- Cephalosporins
- Thiazines
- Biogenic Monoamines
- Biogenic Amines
- Catecholamines
- Prednisolone
- Anesthetists
- Bupivacaine
- Methylprednisolone
- Cefazolin
- Epinephrine
- Saline Solution
- Surgeons
- Anesthesiologists
Other Study ID Numbers
- ANES-TKA-2025-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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