PENG Block for Total Hip Arthroplasty

Periarticular Nerve Group (PENG) Block for Postoperative Rehabilitation in Total Hip Arthroplasty: a Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Hip Pain Chronic; Hip Osteoarthritis; Hip Disease; Hip Arthropathy
• Intervention / Treatment: Drug: Ropivacaine 0.5% Injectable Solution; Drug: 0,9% normal saline

Detailed Description

The pericapsular nerve group, or PENG block, has been recently described and shows promise in providing analgesia to the hip joint. However, the effect of this block on postoperative rehabilitation is uncertain. This study compares a preoperative PENG block to a placebo before total hip arthroplasty under spinal anesthesia. The primary outcome measure is verticalization, walking distance, ability to go out of bed, active lifting of the limb, range of motion in the hip joint, bending range of motion, and abduction range of motion. The secondary measure is postoperative pain assessment during rehabilitation.

• Study Type: Interventional
• Enrollment (Actual): 556
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Wielkopolska
    • Poznań, Wielkopolska, Poland, 61-701
      • Poznan Univesity of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients > 18 years old undergoing unilateral total hip arthroplasty

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PENG with 20mL 0,5% Ropivacaine; 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; 20 mL 0.5% ropivacaine will be injected for the PENG block; Other Names: Ropimol
Experimental: PENG block with 20mL 0,9% normal saline; 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; 20 mL 0.9% normal saline will be injected for the PENG block; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
total opioid consumption	milligrams of intravenous morphine equivalents	96 hours postoperatively
Time to first opioid	Hours to first administration of an intravenous opioid drug	96 hours postoperatively
postoperative Numeric Pain Rating Scale et rest	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 1
postoperative Numeric Pain Rating Scale et rest	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 et rest	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 et rest	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
Functional assessment: getting out of bed without help	Binary assessment of motor function evaluated at the first day after surgical procedure	First day after surgery
Functional assessment: active elevation of the operated limb	Binary assessment of motor function evaluated at the first day after surgical procedure	First day after surgery
Functional assessment: independent verticalization- by the balcony	Binary assessment of motor function evaluated at the first day after surgical procedure	First day after surgery
Functional assessment: walking by the balcony	Binary assessment of motor function evaluated at the first day after surgical procedure	First day after surgery

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Principal Investigator: Małgorzata Domagalska, PhD, Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland; Study Chair: Zbigniew Żaba, PhD, Department of Emergency Medicine Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: February 19, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: total hip arthroplasty; pain management; regional anesthesia; multimodal analgesia; periarticular nerve group block
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 496/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data presented in this study are available on request from the corresponding author.
• IPD Sharing Time Frame: December 2024
• IPD Sharing Access Criteria: The data presented in this study are available on request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No