Skip to main content
OpenTrials
Completed

NCT Number: NCT05432011

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Acute Pain Agnosia Analgesia Hip Arthropathy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus Bio-medico University Hospital Foundation

Rome, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PENG block

Procedure

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.

Lateral femoral cutaneous nerve block

Procedure

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.

Wound Infiltration

Procedure

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

Primary outcomes

  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 outcomes

  1. Morphine consumption

    Time frame: 24 hours

    Total of intravenous morphine (expressed in milligrams) administered during the first 24 hours after surgery

  2. Morphine consumption

    Time frame: 6 days

    Total of intravenous morphine (expressed in milligrams) administered during the entire hospitalization

  3. Range of hip motion

    Time frame: 24 hours

    Degrees of hip flexion

  4. Quadriceps Strength

    Time frame: 24 hours

    Ability to flex the knee against gravity

  5. 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

  6. 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

  7. 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

  8. Hospital Length of Stay

    Time frame: 6 days

    Total Hospital length of Stay (expressed in days)

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study 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

Acronym: PENG-FLAT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 24, 2022
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.