Erector Spinae Plane Block Vs. IPACK Block with Adductor Canal Block for Total Knee Arthroplasty

NCT06233630 | Completed Phase 4

• 1 other identifier: 4/2024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Effect of Erector Spinae Plane Block and iPACK block with Adductor Canal Block on pain management, and NLR and PLR following knee arthroplasty

Conditions

Knee Osteoarthritis; Knee Pain Chronic; Knee Arthritis

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  Total opiate consumption after surgery

  48 hours

Secondary Outcomes (10)

• first need of opiate

  48 hours

• Numerical Rating Scale [range 0:10]

  4 hours after surgery

• Numerical Rating Scale [range 0:10]

  8 hours after surgery

• Numerical Rating Scale [range 0:10]

  12 hours after surgery

• Numerical Rating Scale [range 0:10]

  16 hours after surgery

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Only spinal anaesthesia - No peripheral nerve block

Drug: Control Test - spinal anesthesia

Erector Spinae Plane Block

ACTIVE COMPARATOR

spinal anaesthesia and unilateral ultrasound guided erector spinae plane block - 20ml 0.2% ropivacaine

Drug: Ropivacaine 0.2% Injectable Solution ESPB

Infiltration Popliteal Artery and Capsule of the Knee and Adductor Canal Block

ACTIVE COMPARATOR

spinal anaesthesia and ultrasound guided Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee (iPACK) block - 20ml 0.2% ropivacaine \+ ultrasound guided Adductor Canal Block - 10ml 0.2% ropivacaine

Drug: Ropivacaine 0.2% Injectable Solution iPACK+ACB

Interventions

Control Test - spinal anesthesia DRUG

No peripheral nerve block Only spinal anesthesia

Also known as: spinal anesthesia

Placebo

Ropivacaine 0.2% Injectable Solution ESPB DRUG

ultrasound guided erector spinae plane block (ESPB) - L2 level, unilateral

Also known as: erector spinae plane block

Erector Spinae Plane Block

Ropivacaine 0.2% Injectable Solution iPACK+ACB DRUG

ultrasound guided iPACK block + Adductor Canal Block

Also known as: iPACK+ACB

Infiltration Popliteal Artery and Capsule of the Knee and Adductor Canal Block

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ASA classification I-III,
• Aged 20-100 years,
• scheduled for knee arthroplasty under spinal anaesthesia

You may not qualify if:

• Patients who have a history of bleeding diathesis,
• Take anticoagulant therapy,
• have a History of chronic pain before surgery,
• have Multiple trauma,
• cannot assess their pain (dementia),
• have been operated on under general anaesthesia,
• have an infection in the area
• do not accept the procedure

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Anesthesia, Spinal; Ropivacaine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Malgorzata Domagalska, Ph.D.

  Poznan University of Medical Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: March 30, 2024
• Primary Completion: August 16, 2024
• Study Completion: August 20, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)