CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
iPACK +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04565093
NCT04565093N/ACompleted

Efficacy of iPACK (Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) Versus Periarticular Local Infiltration Analgesia After Unilateral Total Knee Arthroplasty: Prospective Randomized Control Trial

King Khalid University Hospital·interventional·Posted Sep 25, 2020·Updated Jun 1, 2021

In Brief

A clinical study evaluating iPACK and Periarticular local infiltration analgesia (LIA) for Arthroplasty Complications and 3 related conditions. Completed, enrolled 80 participants across 1 site.

Detailed Summary

Total knee arthroplasty (TKA) is a common orthopedic procedure associated with severe postoperative pain which may limit patient rehabilitation and hospital discharge. Although various analgesic techniques have been proposed, there is currently no consensus on the optimal protocol to improve functional outcomes following TKA. The ideal analgesic regimen post TKA should enable adequate pain control, early mobilization and physical therapy, shorten hospital stay, reduce the risk of postoperative complications and improve patient satisfaction. Our hypothesis is iPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) peripheral nerves anesthetic block is superior to Periarticular local Infiltration Analgesia (LIA)which is commonly given by the surgeons during the TKA in terms of pain relief and early mobilization.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSaudi Arabia
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 25, 2020
Enrollment StartSep 28, 2020
Primary CompletionMar 24, 2021
Study CompletionMar 27, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.8 years ago

Interventions

iPACKprocedure

Interspace between the popliteal artery and the capsule of the posterior knee (iPACK): This is basically ultrasound guided peripheral nerve block performed by the anesthesiologists at the posterior side of the knee to control pain after TKA.

Periarticular local infiltration analgesia (LIA)procedure

A mixture of Bupivacaine 0.25% 20 ml + epinephrine 100 mics ± lornoxicam 8 mg ± morphine 10 mg ± tranexamic acid 1 gm in 40 ml normal saline (NS) will be injected into the posterior capsule and the medial and lateral ligaments just before implantation: after insertion of the implants and into the capsule and retinacular tissues. The remaining solution (approximately 20 mL) will be used to infiltrate the muscle and subcutaneous tissues. This intervention is commonly performed by the operating orthopedic surgeon to control pain after TKA.