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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05432011
Recruitment Status : Not yet recruiting
First Posted : June 24, 2022
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
Giuseppe Pascarella, Campus Bio-Medico University

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


Condition or disease Intervention/treatment Phase
Pain Postoperative Pain Acute Pain Analgesia Hip Arthropathy Postoperative Complications Procedure: PENG Block Procedure: Lateral Femoral Cutaneous Nerve Block Procedure: Wound Infiltration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PENG Block Combined to Lateral Femoral Cutaneous Block vs. PENG Block Combined to Wound Infiltration for Postoperative Analgesia Following Posterolateral-approached Total Hip Arthroplasty
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : April 2, 2023
Estimated Study Completion Date : April 3, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PENG block plus Femoral Cutaneous Nerve Block
Participants receiving PENG block combined to Lateral Femoral Cutaneous Nerve Block
Procedure: PENG Block
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.

Procedure: Lateral Femoral Cutaneous Nerve Block
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.

Active Comparator: PENG block plus Wound Infiltration
Participants receiving PENG block combined to wound infiltration
Procedure: PENG Block
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.

Procedure: Wound Infiltration
At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.5 % Ropivacaine.




Primary Outcome Measures :
  1. Static Pain Score [ Time Frame: 24 hours ]
    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

  2. Dynamic Pain Score [ Time Frame: 24 hours ]
    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 :
  1. Morphine consumption [ Time Frame: 48 hours ]
    Total of intravenous morphine (expressed in milligrams) administered during the first 48 hours after surgery

  2. Range of hip motion [ Time Frame: 24 hours ]
    Degrees of hip flexion

  3. Quadriceps Strength [ Time Frame: 24 hours ]
    Ability to flex the knee against gravity

  4. Ability to start physiotherapy during the first postoperative day [ Time Frame: 24 hours ]
    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

  5. Ability to ambulate with the help of a walker during the first postoperative day [ Time Frame: 24 hours ]
    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

  6. Incidence of block complications [ Time Frame: 24 hours ]

    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


  7. Hospital Length of Stay [ Time Frame: 96 hours ]
    Total Hospital length of Stay (expressed in days)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05432011


Contacts
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Contact: Giuseppe Pascarella, MD 00393204022283 g.pascarella@policlinicocampus.it

Locations
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Italy
Università Campus Biomedico
Roma, Italy
Sponsors and Collaborators
Campus Bio-Medico University
Investigators
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Principal Investigator: Giuseppe Pascarella, MD University Hospital Campus Biomedico of Rome
Publications of Results:
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Responsible Party: Giuseppe Pascarella, Principal Investigator, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT05432011    
Other Study ID Numbers: PAR 34.22
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postoperative Complications
Acute Pain
Pathologic Processes
Pain
Neurologic Manifestations