Erector Spinae vs. PENG Block for Total Hip Arthroplasty

NCT06083428 | Completed Phase 4

• 1 other identifier: 11/2023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Effect of PENG block and ESPB on pain management, and NLR and PLR following knee arthroplasty

Conditions

Hip Arthropathy; Hip Osteoarthritis; Hip Pain Chronic

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  Total opiate consumption after surgery

  48 hours after surgery

Secondary Outcomes (13)

• first need of opiate

  48 hours after procedure

• 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]

  18 hours after surgery

Study Arms (3)

PENG Block group

ACTIVE COMPARATOR

ultrasound guided PENG block - 20ml 0,2% ropivacaine

Drug: Ropivacaine 0.2% Injectable Solution - PENG block

ESPB group

ACTIVE COMPARATOR

ultrasound guided erector spinae plane block - 20ml 0,2% ropivacaine

Drug: Ropivacaine 0.2% Injectable Solution Erector Spinae Plane Block

Control group

ACTIVE COMPARATOR

Only spinal anesthesia - No peripheral nerve block

Drug: Control Test

Interventions

Ropivacaine 0.2% Injectable Solution Erector Spinae Plane Block DRUG

ultrasound guided ESPB - L4 level, unilateral

Also known as: Erector Spinae Plane Block

ESPB group

Ropivacaine 0.2% Injectable Solution - PENG block DRUG

ultrasound guided PENG block

Also known as: PENG block

PENG Block group

Control Test DRUG

Only spinal anesthesia

Also known as: No peripheral nerve block

Control group

Eligibility Criteria

• Age: 20 Years - 90 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 20-90 years, Who will be scheduled for hip arthroplasty under spinal anesthesia.

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 anesthesia, have an infection in the area and do not accept the procedure

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Poznań, 61-701, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Małgorzata Domagalska, Ph.D.

  Poznań University of Medical Sciences

  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: May 24, 2023
• First Posted: October 16, 2023
• Study Start: October 17, 2023
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)