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NCT Number: NCT04306133

PENG Block Combined to Wound Infiltration for Hip Replacement

This study analyze the effect of Pericapsular Nerve Group (PENG) Block combined to wound infiltration for analgesia after elective hip replacement.

Half of participants will receive a PENG Block combined with wound infiltration, while the other half will receive wound infiltration alone.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università Campus Biomedico

Roma, 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
  • ASA physical status score < 4

Exclusion criteria

  • Contraindications to regional anesthesia
  • ASA physical status score ≥ 4
  • Patient's refusal or inability to sing the informed consent
  • Pre-operatively therapy with opioids
  • Allergies to any drug provided by the study protocol

Treatment and study plan

PENG block

Procedure

After performing spinal anesthesia, PENG block with 20 mL of 0.375 % Ropivacaine will be executed as described by Giron-Arongo et al with a low frequency curvilinear probe. A 22G 80 mm needle (Stimuplex Ultra 360, Braun ) will be used.

Wound Infiltration

Procedure

At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.375 % Ropivacaine.

Primary outcomes

  1. Maximum Pain Score

    Time frame: 24 hours

    A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain during 48 h after surgery

  2. Total opioids consumption

    Time frame: 48 hours

    Total of Sublingual Sufentanil tablets released

Secondary outcomes

  1. Time to first opioid

    Time frame: 48 hours

    Time (hours) from the end of surgery to the first opioid administration

  2. Range of hip motion

    Time frame: 24 hours

    Degrees of hip flexion

  3. Time to ambulation

    Time frame: 48 hours

    Time until the patient is able to stand up and walk with or without assistive devices

  4. Quadriceps weakness

    Time frame: 48 hours

    Presence of weakness of the quadriceps using a scale where 0= no effect; 1 = knee flexion possible but not hip flexion; 2 = absence of knee and hip flexion

  5. Incidence of block complications

    Time frame: 48 hours

    Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity.

  6. Opioids side effects

    Time frame: 48 hours

    The presence or absence of opioids side effects such as drowsiness, desaturation, nausea and vomiting

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

Pericapsular Nerve Group (PENG) Block Combined to Wound Infiltration vs. Wound Infiltration Alone for Postoperative Analgesia After Total Hip Replacement: a Prospective Controlled Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2020
Registry last updated
Apr 6, 2021

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.

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