Effect of iPACK and BiFeS Blocks on Quality of Recovery After Total Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAtaturk University
About this trial
This prospective, randomized, double-blind clinical trial aims to compare the effects of two different posterior knee analgesia techniques-iPACK block (Interspace Between the Popliteal Artery and the Capsule of the posterior Knee) and the Biceps Femoris Short Head (BiFeS) block-when combined with an adductor canal block (ACB) in patients undergoing elective unilateral total knee arthroplasty (TKA). Effective postoperative analgesia is essential for early mobilization, enhanced recovery, and patient satisfaction after TKA. Although ACB provides good anterior knee analgesia while preserving quadriceps strength, additional posterior knee analgesia is often required.
The iPACK block is a commonly used technique that targets the posterior knee capsule, whereas the newer BiFeS block aims to provide more selective posterolateral sensory blockade with potentially reduced risk of motor involvement. However, comparative clinical data between these two techniques are limited.
The primary objective of this study is to evaluate the difference between the iPACK and BiFeS blocks in terms of Quality of Recovery-15 (QoR-15) scores at 24 hours postoperatively. Secondary objectives include comparisons of postoperative pain scores, opioid consumption, time to first analgesic request, quadriceps and anterior tibialis muscle strength, functional test performance, time to mobilization, active range of motion, and the incidence of adverse events.
A total of 74 adult patients scheduled for elective unilateral TKA under spinal anesthesia will be randomized in a 1:1 ratio into two groups: ACB + iPACK block or ACB + BiFeS block. All blocks will be performed under ultrasound guidance by an experienced anesthesiologist. Outcome assessments will be conducted by blinded investigators. The study aims to provide high-quality clinical evidence regarding the effectiveness of the BiFeS block compared to the widely used iPACK technique.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years
Scheduled for elective primary unilateral total knee arthroplasty (TKA)
Planned spinal anesthesia
ASA physical status I-III
Disqualifiers
Known allergy or hypersensitivity to local anesthetics or other study medications
Coagulopathy or current anticoagulant therapy
Severe hepatic, renal, or cardiac failure
History of neuropathic pain
Trial design
Design model
Parallel
Treatments tested in this trial
Adductor Canal Block (ACB) Only
Procedure/SurgeryAn ultrasound-guided adductor canal block (ACB) will be performed using 15 mL of 0.25% bupivacaine. The probe will be placed on the proximal thigh to visualize the sartorius muscle and femoral artery. The needle will be advanced in-plane into the adductor canal, and correct placement will be confirmed with 2 mL saline before injection. This block aims to provide anterior knee analgesia while preserving quadriceps strength.
IPACK block
Procedure/SurgeryThe iPACK block will be performed by placing the ultrasound probe at the popliteal region to visualize the popliteal artery and posterior knee capsule. A needle will be advanced in-plane, and 25 mL of 0.25% bupivacaine will be injected between the artery and posterior capsule. This block targets posterior knee pain after total knee arthroplasty without causing motor block.
BiFeS Block
Procedure/SurgeryThe BiFeS block will be performed with the ultrasound probe placed laterally to visualize the femur cortex and the long and short heads of the biceps femoris muscle. The needle will be advanced in-plane into the potential space between the femur and the short head of the biceps femoris. After confirming position with 2 mL saline, 25 mL of 0.25% bupivacaine will be injected. This block provides posterolateral knee analgesia with limited motor involvement.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Adductor Canal Block + iPACK BlockActive comparator 2 interventions
Group B: Adductor Canal Block + BiFeS BlockExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Quality of Recovery-15 (QoR-15) Score at 24 Hours
The Quality of Recovery-15 (QoR-15) questionnaire is a validated patient-reported outcome measure assessing overall postoperative recovery across domains such as pain, physical comfort, physical independence, psychological support, and emotional well-being. The total score ranges from 0 to 150, with higher scores indicating better recovery. The outcome compares 24-hour QoR-15 scores between the ACB + iPACK group and the ACB + BiFeS group.
Time frame
24 hours postoperativelySecondary outcomes
1
Quality of Recovery-15 (QoR-15) Score at 48 Hours
The QoR-15 questionnaire assesses multidimensional postoperative recovery, with scores ranging from 0 to 150 (higher scores indicate better recovery). This outcome compares 48-hour QoR-15 scores between the ACB + iPACK and ACB + BiFeS groups.
Time frame
48 hours postoperatively2
Pain Scores (VAS) at Rest and During Movement
Pain intensity will be evaluated using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain). Assessments will be performed at rest and during movement at predefined postoperative time points.
Time frame
2, 4, 8, 12, 24, and 48 hours postoperatively3
Opioid Consumption (Fentanyl PCA)
Total fentanyl consumption will be extracted from patient-controlled analgesia (PCA) device records, including total delivered dose and number of boluses.
Time frame
24 and 48 hours postoperatively4
Time to First Opioid Request
The interval between the end of surgery and the patient's first demand for opioid analgesia via PCA will be recorded, indicating the duration of effective postoperative analgesia.
Time frame
Up to 48 hours postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov