Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
Study NCT ID:
NCT07267650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-11-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
iPACK Block vs. Periarticular Infiltration for TKA Pain Control
Sponsor:
Turgutlu State Hospital
Organization:
Study Overview
Official Title:
Analgesic Efficacy of iPACK Block Versus Periarticular Infiltration as an Adjunct to Femoral Triangle Block in Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind, Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to compare two different multimodal analgesic techniques for pain management after total knee arthroplasty (TKA). The primary purpose is to determine if a combination of two specific nerve blocks administered by an anesthesiologist (Femoral Triangle Block + iPACK block) results in superior pain control compared to a 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 will lead to a significant reduction in Numeric Rating Scale (NRS) pain scores with movement at 24 hours postoperatively.
This will be a prospective, randomized, double-blind, parallel-group, single-center study involving patients scheduled for primary unilateral TKA. Participants will be randomly assigned to one of two groups. All patients, clinicians (anesthesiologists and surgeon), and outcome assessors will be blinded to the group allocation using a double-dummy technique.
The hypothesis is that the FTB + iPACK combination will lead to a significant reduction in Numeric Rating Scale (NRS) pain scores with movement at 24 hours postoperatively.
This will be a prospective, randomized, double-blind, parallel-group, single-center study involving patients scheduled for primary unilateral TKA. Participants will be randomly assigned to one of two groups. All patients, clinicians (anesthesiologists and surgeon), and outcome assessors will be blinded to the group allocation using a double-dummy technique.
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 outcomes compared to a hybrid approach involving both the anesthesiologist and the surgeon (FTB + PAI).
This prospective, randomized, double-blind controlled trial is designed to compare these two advanced analgesic combinations. All patients will receive a standardized spinal anesthetic (3 mL of 0.5% heavy bupivacaine). The study will evaluate which method provides better pain control, measured primarily by Numeric Rating Scale (NRS) pain scores at 24 hours, and secondarily by total rescue analgesic (tramadol) consumption, functional recovery (Timed Up and Go test and Straight Leg Raise test), and knee range of motion.
Sample size will be determined based on an internal pilot study. An initial 30 patients (15 per group) will be enrolled. The mean and standard deviation of the primary outcome (NRS pain score with movement at 24 hours) from this pilot cohort will be used to calculate the final sample size required to detect a clinically significant difference (e.g., 1 point on the NRS) with 80% power and an alpha of 0.05. The final enrollment target is estimated to be approximately 100 patients (50 per group) to account for potential dropouts.
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 outcomes compared to a hybrid approach involving both the anesthesiologist and the surgeon (FTB + PAI).
This prospective, randomized, double-blind controlled trial is designed to compare these two advanced analgesic combinations. All patients will receive a standardized spinal anesthetic (3 mL of 0.5% heavy bupivacaine). The study will evaluate which method provides better pain control, measured primarily by Numeric Rating Scale (NRS) pain scores at 24 hours, and secondarily by total rescue analgesic (tramadol) consumption, functional recovery (Timed Up and Go test and Straight Leg Raise test), and knee range of motion.
Sample size will be determined based on an internal pilot study. An initial 30 patients (15 per group) will be enrolled. The mean and standard deviation of the primary outcome (NRS pain score with movement at 24 hours) from this pilot cohort will be used to calculate the final sample size required to detect a clinically significant difference (e.g., 1 point on the NRS) with 80% power and an alpha of 0.05. The final enrollment target is estimated to be approximately 100 patients (50 per group) to account for potential dropouts.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: