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Efficacy of iPACK After Unilateral TKA

NCT04565093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-06-01

No results posted yet for this study

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.

Conditions

  • Arthroplasty Complications
  • Pain, Joint
  • Arthritis Knee
  • Regional Anesthesia Morbidity

Interventions

PROCEDURE

iPACK

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.

PROCEDURE

Periarticular local infiltration analgesia (LIA)

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.

Sponsors & Collaborators

  • King Khalid University Hospital

    lead OTHER

Principal Investigators

  • Abdul Sattar Narejo, FCPS, FCAI · King Saud University College of Medicine and King Khalid University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2021-03-24
Completion
2021-03-27

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04565093 on ClinicalTrials.gov