PENG Block for Total Hip Arthroplasty

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05944380
• Other study ID #: 496/20
• Status: Completed
• Phase: Phase 4
• Start date: June 16, 2020
• Est. completion date: January 30, 2023

Study information

• Verified date: July 2023
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: January 30, 2023
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients > 18 years old undergoing unilateral total hip arthroplasty

Exclusion Criteria:

• refusal to participate

• < 18 yo

• Chronic opioid use

• localized infection

Related Conditions & MeSH terms

• Hip Arthropathy
• Hip Disease
• Hip Osteoarthritis
• Hip Pain Chronic
• Osteoarthritis, Hip

Intervention

Drug:
• Ropivacaine 0.5% Injectable Solution
20 mL 0.5% ropivacaine will be injected for the PENG block
• 0,9% normal saline
20 mL 0.9% normal saline will be injected for the PENG block

Locations

Country	Name	City	State
Poland	Poznan Univesity of Medical Sciences	Poznan	Wielkopolska

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	total opioid consumption	milligrams of intravenous morphine equivalents	96 hours postoperatively
Secondary	Time to first opioid	Hours to first administration of an intravenous opioid drug	96 hours postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Functional assessment: independent verticalization- by the balcony	Binary assessment of motor function evaluated at the first day after surgical procedure	First day after surgery
Secondary	Functional assessment: walking by the balcony	Binary assessment of motor function evaluated at the first day after surgical procedure	First day after surgery