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PENG Block Plus Lateral Femoral Cutaneous Nerve Block for Posterolateral-approached Total Hip Arthroplasty (PENG-FLAT)

Primary Purpose

Pain, Postoperative Pain, Acute Pain

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PENG Block
Lateral Femoral Cutaneous Nerve Block
Wound Infiltration
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective hip replacement surgery performed with a poster-lateral approach
  • ASA physical status score < 4

Exclusion Criteria:

  • Contraindications to regional anesthesia
  • ASA physical status score ≥ 4
  • Patient's refusal or inability to sign the informed consent
  • Allergies to any drug provided by the study protocol

Sites / Locations

  • Campus Bio-medico University Hospital Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PENG block plus Femoral Cutaneous Nerve Block

PENG block plus Wound Infiltration

Arm Description

Participants receiving PENG block combined to Lateral Femoral Cutaneous Nerve Block

Participants receiving PENG block combined to wound infiltration

Outcomes

Primary Outcome Measures

Static Pain Score
A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery
Dynamic Pain Score
A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain on movement during 24 hours after surgery

Secondary Outcome Measures

Morphine consumption
Total of intravenous morphine (expressed in milligrams) administered during the first 24 hours after surgery
Morphine consumption
Total of intravenous morphine (expressed in milligrams) administered during the entire hospitalization
Range of hip motion
Degrees of hip flexion
Quadriceps Strength
Ability to flex the knee against gravity
Ability to start physiotherapy during the first postoperative day
YES: the patient was able to start physiotherapy NO: the patient was not able to start physiotherapy during the first postoperative day due to pain or motor block
Ability to ambulate with the help of a walker during the first postoperative day
YES: The patient was able to ambulate with the help of a walker NO: The patient was not able to ambulate with the help of a walker due to pain or motor block
Incidence of block complications
Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity. Moreover, incidence of nausea, vomiting and postoperative respiratory depression will be recorded
Hospital Length of Stay
Total Hospital length of Stay (expressed in days)

Full Information

First Posted
June 20, 2022
Last Updated
August 29, 2023
Sponsor
Campus Bio-Medico University
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1. Study Identification

Unique Protocol Identification Number
NCT05432011
Brief Title
PENG Block Plus Lateral Femoral Cutaneous Nerve Block for Posterolateral-approached Total Hip Arthroplasty
Acronym
PENG-FLAT
Official Title
PENG Block Combined to Lateral Femoral Cutaneous Nerve Block vs. PENG Block Combined to Wound Infiltration for Postoperative Analgesia Following Posterolateral-approached Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
May 18, 2023 (Actual)
Study Completion Date
May 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University

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 study aims to analyze the effect of Pericapsular Nerve Group (PENG) Block combined with lateral femoral cutaneous nerve block vs. PENG block combined with wound infiltration for analgesia after elective hip replacement performed with a posters-lateral approach. Half of participants will receive a PENG Block combined with femoral lateral cutaneous nerve block, while the other half will receive PENG Block combined with wound infiltration

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative Pain, Acute Pain, Analgesia, Hip Arthropathy, Postoperative Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PENG block plus Femoral Cutaneous Nerve Block
Arm Type
Experimental
Arm Description
Participants receiving PENG block combined to Lateral Femoral Cutaneous Nerve Block
Arm Title
PENG block plus Wound Infiltration
Arm Type
Active Comparator
Arm Description
Participants receiving PENG block combined to wound infiltration
Intervention Type
Procedure
Intervention Name(s)
PENG Block
Intervention Description
At the end of surgery, in Post Anesthesia Recovery Room (PACU), PENG block with 20 mL of 0.5 % Ropivacaine will be executed as described by Giron-Arango et al. using a low frequency curvilinear probe. A 22G 80 mm needle (Stimuplex Ultra 360, B.Braun) will be used.
Intervention Type
Procedure
Intervention Name(s)
Lateral Femoral Cutaneous Nerve Block
Intervention Description
At the end of surgery, in Post Anesthesia Recovery Room (PACU), ultrasound guided Lateral Femoral Cutaneous Nerve Block will be performed with 10 mL of 0.5 % Ropivacaine using a high frequency linear probe. A 22G 50 mm needle (Stimuplex Ultra 360, B.Braun) will be used.
Intervention Type
Procedure
Intervention Name(s)
Wound Infiltration
Intervention Description
At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.5 % Ropivacaine.
Primary Outcome Measure Information:
Title
Static Pain Score
Description
A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery
Time Frame
24 hours
Title
Dynamic Pain Score
Description
A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain on movement during 24 hours after surgery
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Morphine consumption
Description
Total of intravenous morphine (expressed in milligrams) administered during the first 24 hours after surgery
Time Frame
24 hours
Title
Morphine consumption
Description
Total of intravenous morphine (expressed in milligrams) administered during the entire hospitalization
Time Frame
6 days
Title
Range of hip motion
Description
Degrees of hip flexion
Time Frame
24 hours
Title
Quadriceps Strength
Description
Ability to flex the knee against gravity
Time Frame
24 hours
Title
Ability to start physiotherapy during the first postoperative day
Description
YES: the patient was able to start physiotherapy NO: the patient was not able to start physiotherapy during the first postoperative day due to pain or motor block
Time Frame
24 hours
Title
Ability to ambulate with the help of a walker during the first postoperative day
Description
YES: The patient was able to ambulate with the help of a walker NO: The patient was not able to ambulate with the help of a walker due to pain or motor block
Time Frame
24 hours
Title
Incidence of block complications
Description
Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity. Moreover, incidence of nausea, vomiting and postoperative respiratory depression will be recorded
Time Frame
24 hours
Title
Hospital Length of Stay
Description
Total Hospital length of Stay (expressed in days)
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective hip replacement surgery performed with a poster-lateral approach ASA physical status score < 4 Exclusion Criteria: Contraindications to regional anesthesia ASA physical status score ≥ 4 Patient's refusal or inability to sign the informed consent Allergies to any drug provided by the study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Pascarella, MD
Organizational Affiliation
University Hospital Campus Biomedico of Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Campus Bio-medico University Hospital Foundation
City
Rome
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34196965
Citation
Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.
Results Reference
result
PubMed Identifier
34290085
Citation
Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.
Results Reference
result
PubMed Identifier
30063657
Citation
Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
Results Reference
result
PubMed Identifier
33432791
Citation
Del Buono R, Padua E, Pascarella G, Costa F, Tognu A, Terranova G, Greco F, Fajardo Perez M, Barbara E. Pericapsular nerve group block: an overview. Minerva Anestesiol. 2021 Apr;87(4):458-466. doi: 10.23736/S0375-9393.20.14798-9. Epub 2021 Jan 12.
Results Reference
result

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PENG Block Plus Lateral Femoral Cutaneous Nerve Block for Posterolateral-approached Total Hip Arthroplasty

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