PENG Block for Total Hip Arthroplasty

Phase 4

Completed

• Conditions: Hip Arthropathy; Hip Osteoarthritis; Hip Disease; Hip Pain Chronic
• Interventions: Drug: 0,9% normal saline; Drug: Ropivacaine 0.5% Injectable Solution

• Registration Number: NCT05944380
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

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

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 Timeline

• Study Start: 2020-06-16
• Primary Completion: 2022-06-23
• Study Completion: 2023-01-30
• Study First Submitted: 2023-02-19
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-05
• Last Update Submitted: 2023-07-05
• Study First Posted: 2023-07-13
• Last Update Posted: 2023-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 556

Inclusion Criteria

• Patients > 18 years old undergoing unilateral total hip arthroplasty

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PENG block with 20mL 0,9% normal saline	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.
PENG with 20mL 0,5% Ropivacaine	Ropivacaine 0.5% Injectable Solution	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.

Primary Outcome Measures

Name	Time	Method
postoperative Numeric Pain Rating Scale in motion	Day 4	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")

Secondary Outcome Measures

Name	Time	Method
Time to first opioid	96 hours postoperatively	Hours to first administration of an intravenous opioid drug
total opioid consumption	96 hours postoperatively	milligrams of intravenous morphine equivalents
Functional assessment: independent verticalization- by the balcony	First day after surgery	Binary assessment of motor function evaluated at the first day after surgical procedure
postoperative Numeric Pain Rating Scale et rest	Day 4	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")
Functional assessment: getting out of bed without help	First day after surgery	Binary assessment of motor function evaluated at the first day after surgical procedure
Functional assessment: active elevation of the operated limb	First day after surgery	Binary assessment of motor function evaluated at the first day after surgical procedure
Functional assessment: walking by the balcony	First day after surgery	Binary assessment of motor function evaluated at the first day after surgical procedure

Trial Locations

Locations (1)

Poznan Univesity of Medical Sciences; 🇵🇱 Poznań, Wielkopolska, Poland