PENG Block for Total Hip Arthroplasty

Sponsor

Poznan University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT05944380

Collaborator

(none)

556

Enrollment

Location

Arms

31.5

Actual Duration (Months)

17.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hip Osteoarthritis Hip Arthropathy Hip Disease Hip Pain Chronic	Drug: Ropivacaine 0.5% Injectable Solution Drug: 0,9% normal saline	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

556 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized, double-blind, placebo-controlledrandomized, double-blind, placebo-controlled

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 16, 2020

Actual Primary Completion Date :

Jun 23, 2022

Actual Study Completion Date :

Jan 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

postoperative Numeric Pain Rating Scale in motion [Day 2]
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")
postoperative Numeric Pain Rating Scale in motion [Day 3]
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")
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

total opioid consumption [96 hours postoperatively]
milligrams of intravenous morphine equivalents
Time to first opioid [96 hours postoperatively]
Hours to first administration of an intravenous opioid drug
postoperative Numeric Pain Rating Scale et rest [Day 1]
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")
postoperative Numeric Pain Rating Scale et rest [Day 2]
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")
postoperative Numeric Pain Rating Scale et rest [Day 3]
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")
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: independent verticalization- by the balcony [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients > 18 years old undergoing unilateral total hip arthroplasty

Exclusion Criteria:

refusal to participate
< 18 yo
Chronic opioid use
localized infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Poznan Univesity of Medical Sciences	Poznań	Wielkopolska	Poland	61-701

Sponsors and Collaborators

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