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Completed

NCT Number: NCT04295421

IPACK Block After Total Knee Arthroplasty

Adductor canal block (ACB) is a peripheral nerve blockade technique that provides good pain control in patients undergoing total knee arthroplasty (TKA) which however does not relieve posterior knee pain. The recent technique of an ultrasound-guided local anesthetic infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) has shown promising results in providing significant posterior knee analgesia without affecting the motor nerves. The hypothesis was that the combination of ACB + IPACK will provide better pain relief and improve knee function in the immediate postoperative period compared to ACB alone.

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Key information

Conditions

Knee Arthropathy Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Pain Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Kassab D'Orthopedie

Tunis, 2010, Tunisia

About this study

This is a prospective, randomized and double blinded study

All patients received :

  • Pregabalin 150 mg preoperatively 12 h before the surgery.
  • Single-shot spinal anesthesia with 10 to 12 mg of bupivacaine 0.5% and 2.5ug sufentanil patients were randomly allocated to receive:
  • Group 1: IPACK + ACB single shoot
  • Group 2: contineous ACB For group 1: IPACK was realized after spinal anesthesia with 40 ml ropivacaine 0.2% All patients received ACB in the immediate postoperative period with 20 ml ropivacaine 0.2%

Post operative analgesia included:

  • Paracetamol 1g IV every 6 hours
  • Diclofenac sodium (50mg) 1 tablet x 2 per day
  • Pregabalin 150 mg given orally once daily for a period of 4 weeks.
  • PCA morphine (Patient Controlled Analgesia), as a rescue analgesia,
  • Continuous ACB catheter for 48H with :

4 ml per hour 0.2% ropivacaine in group 2 4 ml per hour saline in group 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary total knee arthroplasty under spinal anesthesia

Exclusion criteria

  • Contraindication or refusal to regional anesthesia
  • Contraindication to non steroidal anti inflammatory (NSAID's)
  • Allergy to opioids
  • Allergy to paracetamol
  • Creatinine clearance < 30ml/min
  • Weight<50 kg or >100kg

Treatment and study plan

Adductor canal block

Procedure

ACB was done in the immediate postoperative period under a high-frequency ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.2% ropivacaine was injected in the canal using a 22-gauge 100-mm short-beveled regional block needle and a catheter was kept for 48H with 4 ml/h ropivacaine 0.2%.

IPACK block

Procedure

IPACK block was realized after spinal anesthesia with 40 ml 0.2% ropivacaine and at the end of surgery , patients were given ACB with 20 ml 0.2% ropivacaine and continued with 4 ml/H saline for 48H

Primary outcomes

  1. Morphine consumption

    Time frame: Day 2

    total Morphine consumption

Secondary outcomes

  1. Pain score at rest

    Time frame: Day 2

    numerical rating scale [0=no pain ; 10=worste pain]

  2. Pain score during mouvment

    Time frame: Day 2 [0=no pain ; 10=worste pain]

    numerical rating scale

  3. Ambulation distance

    Time frame: Day 2

    number of steps walked by the patient

  4. Chronic pain

    Time frame: Month 6

    DN4 score [0=minimum to 10= worste score]

  5. functional status

    Time frame: Month 6

    KOOS PS score [0=minimum to 28= worste score]

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Collaborators

  • Institut Kassab d'Orthopédie

Registry information

Official study title

Comparison of Adductor Canal Block and IPACK Block With Adductor Canal Block Alone After Total Knee Arthroplasty

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2020
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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