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IPACK Block in Total Knee Arthroplasty

A

Asklepieion Voulas General Hospital

Status and phase

Unknown
Phase 2

Conditions

Total Knee Arthroplasty

Treatments

Drug: Adductor Canal Block
Drug: Adductor Canal Block plus IPACK Block

Study type

Interventional

Funder types

Other

Identifiers

NCT03692858
8885/20-06-2018

Details and patient eligibility

About

100 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of two groups, namely group A (n=50), where an adductor canal block and an IPACK block will be performed preoperatively and group B (n=50) where an adductor canal block only will be performed preoperatively. All patients will receive a standardized multimodal approach, including pregabalin, paracetamol, and PCA with morphine. NRS scores in static and dynamic conditions during the first 48 hours postoperatively, morphine consumption during the first 24 hours postoperatively will be measured and additionally, patient satisfaction, complications, range of knee motion, moblization, functionality, delirium ocurence will be recorded. Chronic pain will be assessed in 3 and 6 months postoperatively.

Enrollment

100 estimated patients

Sex

All

Ages

14 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Physical status according to American Society of Anesthesiologists (ASA) I-III
  • Patients scheduled for total knee arthroplasty

Exclusion criteria

  • Previous operation on same knee
  • Contraindication of spinal anesthesia, peripheral nerve blocks or any of the agents used in the protocol
  • BMI above 32
  • Serious psychiatric, mental and cognitive disorders
  • Language barrier
  • Block failure
  • Chronic opioid, gabapentinoid use
  • Severe kidney disfunction

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 2 patient groups

Group A
Active Comparator group
Treatment:
Drug: Adductor Canal Block plus IPACK Block
Group B
Active Comparator group
Treatment:
Drug: Adductor Canal Block

Trial contacts and locations

1

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Central trial contact

Alexandros Makris

Data sourced from clinicaltrials.gov

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