Back to resultsPENG Block for Total Hip Arthroplasty
Primary Purpose
Hip Osteoarthritis, Hip Arthropathy, Hip Disease
Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Ropivacaine 0.5% Injectable Solution
0,9% normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis focused on measuring periarticular nerve group block, total hip arthroplasty, pain management, multimodal analgesia, regional anesthesia
Eligibility Criteria
Inclusion Criteria: Patients > 18 years old undergoing unilateral total hip arthroplasty Exclusion Criteria: refusal to participate < 18 yo Chronic opioid use localized infection
Sites / Locations
- Poznan Univesity of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PENG with 20mL 0,5% Ropivacaine
PENG block with 20mL 0,9% normal saline
Arm Description
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 The needle is withdrawn, and the needle entry site is wiped clean.
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.
Outcomes
Primary Outcome Measures
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")
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")
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")
Secondary Outcome Measures
total opioid consumption
milligrams of intravenous morphine equivalents
Time to first opioid
Hours to first administration of an intravenous opioid drug
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")
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")
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")
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")
Functional assessment: getting out of bed without help
Binary assessment of motor function evaluated at the first day after surgical procedure
Functional assessment: active elevation of the operated limb
Binary assessment of motor function evaluated at the first day after surgical procedure
Functional assessment: independent verticalization- by the balcony
Binary assessment of motor function evaluated at the first day after surgical procedure
Functional assessment: walking by the balcony
Binary assessment of motor function evaluated at the first day after surgical procedure
Full Information
NCT ID
NCT05944380
First Posted
February 19, 2023
Last Updated
July 5, 2023
Sponsor
Poznan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05944380
Brief Title
PENG Block for Total Hip Arthroplasty
Official Title
Periarticular Nerve Group (PENG) Block for Postoperative Rehabilitation in Total Hip Arthroplasty: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
June 23, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poznan University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Hip Arthropathy, Hip Disease, Hip Pain Chronic
Keywords
periarticular nerve group block, total hip arthroplasty, pain management, multimodal analgesia, regional anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, placebo-controlled
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
556 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PENG with 20mL 0,5% Ropivacaine
Arm Type
Experimental
Arm Description
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.
Arm Title
PENG block with 20mL 0,9% normal saline
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5% Injectable Solution
Other Intervention Name(s)
Ropimol
Intervention Description
20 mL 0.5% ropivacaine will be injected for the PENG block
Intervention Type
Drug
Intervention Name(s)
0,9% normal saline
Other Intervention Name(s)
placebo
Intervention Description
20 mL 0.9% normal saline will be injected for the PENG block
Primary Outcome Measure Information:
Title
postoperative Numeric Pain Rating Scale in motion
Description
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")
Time Frame
Day 2
Title
postoperative Numeric Pain Rating Scale in motion
Description
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")
Time Frame
Day 3
Title
postoperative Numeric Pain Rating Scale in motion
Description
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")
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
total opioid consumption
Description
milligrams of intravenous morphine equivalents
Time Frame
96 hours postoperatively
Title
Time to first opioid
Description
Hours to first administration of an intravenous opioid drug
Time Frame
96 hours postoperatively
Title
postoperative Numeric Pain Rating Scale et rest
Description
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")
Time Frame
Day 1
Title
postoperative Numeric Pain Rating Scale et rest
Description
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")
Time Frame
Day 2
Title
postoperative Numeric Pain Rating Scale et rest
Description
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")
Time Frame
Day 3
Title
postoperative Numeric Pain Rating Scale et rest
Description
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")
Time Frame
Day 4
Title
Functional assessment: getting out of bed without help
Description
Binary assessment of motor function evaluated at the first day after surgical procedure
Time Frame
First day after surgery
Title
Functional assessment: active elevation of the operated limb
Description
Binary assessment of motor function evaluated at the first day after surgical procedure
Time Frame
First day after surgery
Title
Functional assessment: independent verticalization- by the balcony
Description
Binary assessment of motor function evaluated at the first day after surgical procedure
Time Frame
First day after surgery
Title
Functional assessment: walking by the balcony
Description
Binary assessment of motor function evaluated at the first day after surgical procedure
Time Frame
First day after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients > 18 years old undergoing unilateral total hip arthroplasty
Exclusion Criteria:
refusal to participate
< 18 yo
Chronic opioid use
localized infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Małgorzata Domagalska, PhD
Organizational Affiliation
Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zbigniew Żaba, PhD
Organizational Affiliation
Department of Emergency Medicine Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Poznan Univesity of Medical Sciences
City
Poznań
State/Province
Wielkopolska
ZIP/Postal Code
61-701
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
PENG Block for Total Hip Arthroplasty
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