PENG Block for Total Hip Arthroplasty

NCT05944380 | Completed Phase 4 DMC

• 1 other identifier: 496/20
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blinded, placebo-controlled trial seeks to evaluate the efficacy of the pericapsular nerve group block on postoperative rehabilitation.

Conditions

Hip Osteoarthritis; Hip Arthropathy; Hip Disease; Hip Pain Chronic

Keywords

periarticular nerve group block; total hip arthroplasty; pain management; multimodal analgesia; regional anesthesia

Outcome Measures

Primary Outcomes (3)

• postoperative Numeric Pain Rating Scale in motion

  Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

  Day 2

• postoperative Numeric Pain Rating Scale in motion

  Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

  Day 3

• postoperative Numeric Pain Rating Scale in motion

  Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

  Day 4

Secondary Outcomes (10)

• total opioid consumption

  96 hours postoperatively

• Time to first opioid

  96 hours postoperatively

• postoperative Numeric Pain Rating Scale et rest

  Day 1

• postoperative Numeric Pain Rating Scale et rest

  Day 2

• postoperative Numeric Pain Rating Scale et rest

  Day 3

Study Arms (2)

PENG with 20mL 0,5% Ropivacaine

EXPERIMENTAL

Patients will receive a preoperative ultrasound-guided pericapsular nerve group block with 20 mL of 0.5% ropivacaine. Using appropriate sterile precautions and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz) or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in the plane with the ultrasound beam, beneath the psoas tendon to the iliopubic eminence. 20 mL 0.5% ropivacaine is injected beneath the psoas tendon and above the iliopubic eminence in 5 mL increments with a periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site is wiped clean.

Drug: Ropivacaine 0.5% Injectable Solution

PENG block with 20mL 0,9% normal saline

EXPERIMENTAL

Patients will receive a preoperative ultrasound-guided pericapsular nerve group block with 20 mL of 0.9% normal saline. Using appropriate sterile precautions and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz) or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in the plane with the ultrasound beam, beneath the psoas tendon to the iliopubic eminence. 20 mL 0.9% normal saline is injected beneath the psoas tendon and above the iliopubic eminence in 5 mL increments with a periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site is wiped clean.

Drug: 0,9% normal saline

Interventions

Ropivacaine 0.5% Injectable Solution DRUG

20 mL 0.5% ropivacaine will be injected for the PENG block

Also known as: Ropimol

PENG with 20mL 0,5% Ropivacaine

0,9% normal saline DRUG

20 mL 0.9% normal saline will be injected for the PENG block

Also known as: placebo

PENG block with 20mL 0,9% normal saline

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years old undergoing unilateral total hip arthroplasty

You may not qualify if:

• refusal to participate
• \< 18 yo
• Chronic opioid use
• localized infection

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan Univesity of Medical Sciences

Poznan, Wielkopolska, 61-701, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Agnosia

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Małgorzata Domagalska, PhD

  Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland

  PRINCIPAL INVESTIGATOR

• Zbigniew Żaba, PhD

  Department of Emergency Medicine Clinic

  STUDY CHAIR

Study Design

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

Model Details: randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: July 13, 2023
• Study Start: June 16, 2020
• Primary Completion: June 23, 2022
• Study Completion: January 30, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: December 2024
• Access Criteria: The data presented in this study are available on request from the corresponding author.

Locations

PL (1)