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Completed

NCT Number: NCT04402450

Suprainguinal Fascia Iliaca Block Versus PENG Block for Hip Arthroplasty Analgesia

In recent years, suprainguinal fascia iliaca block (SFIB) has emerged as a reliable analgesic option for primary total hip arthroplasty (THA). In 2018, a new block was described, termed pericapsular nerve group block or PENG block, that selectively targets the articular branches of the femoral and obturator nerves while sparing their motor components. In this randomized trial, the investigators will compare US-guided SFIB and PENG block in patients undergoing primary THA. Since the main benefit of PENGB stems from its quadriceps-sparing effect, it was selected the incidence of quadriceps motor block (at 6 hours) as the primary outcome and the hypothesis that PENG block will result in significantly less motor block compared to SFIB.

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Key information

Conditions

Postoperative Complications Behavior Motor Activity Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Pain Signs and Symptoms Weakness, Muscle

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universidad de Chile

Santiago, Metropolitan, 8380456, Chile

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 80 years
  • American Society of Anesthesiologists classification 1-3
  • Body mass index between 20 and 35 (kg/m2)

Exclusion criteria

  • Adults who are unable to give their own consent
  • Pre-existing neuropathy (assessed by history and physical examination)
  • Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤a100, International Normalized Ratio ≥01.4 or prothrombin time ≥ 50)
  • Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
  • Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
  • Allergy to local anesthetics (LAs)
  • Pregnancy
  • Prior surgery in the corresponding side of the inguinal or suprainguinal area
  • Chronic pain syndromes requiring opioid intake at home

Treatment and study plan

Ultrasound-guided suprainguinal fascia iliaca nerve block

Procedure

After an ultrasound-guided insertion of a block needle below the inguinal ligament, the needle will be advance in the plane between fascia iliaca and iliopsoas muscle up to a point cranial to the ligament in order to inject a 40 mL of adrenalized 0.25% levobupivacaine.

Ultrasound-guided pericapsular nerves group of the hip block

Procedure

After an ultrasound-guided insertion of a block needle at the level of the inguinal ligament, the needle will be advance into the plane between iliac bone periosteum and the tendon of the iliopsoas muscle in order to inject 20 mL of adrenalized 0.5% levobupivacaine.

Primary outcomes

  1. Presence of quadriceps motor block (defined as paralysis or paresis).

    Time frame: 6 hours after block performance

    Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).

Secondary outcomes

  1. Block performance time

    Time frame: 1 hour after surgery

    temporal interval between the start of skin disinfection and the end of LA injection through the block needle

  2. Static and dynamic pain

    Time frame: 3 hours after the block

    Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

  3. Static and dynamic pain

    Time frame: 6 hours after the block

    Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

  4. Static and dynamic pain

    Time frame: 12 hours after the block

    Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

  5. Static and dynamic pain

    Time frame: 18 hours after the block

    Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

  6. Static and dynamic pain

    Time frame: 24 hours after the block

    Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

  7. Static and dynamic pain

    Time frame: 36 hours after the block

    Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

  8. Static and dynamic pain

    Time frame: 48 hours after the block

    Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

  9. Postoperative morphine consumption

    Time frame: 24 hours after the block

    consumption of intravenous morphine registered by a patient controlled analgesia device

  10. Postoperative morphine consumption

    Time frame: 48 hours after the block

    consumption of intravenous morphine registered by a patient controlled analgesia device

  11. Sensory block

    Time frame: 3 hours after the block

    Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)

  12. Sensory block

    Time frame: 6 hours after the block

    Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)

  13. Sensory block

    Time frame: 24 hours after the block

    Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)

  14. Presence of quadriceps motor block (defined as paralysis or paresis).

    Time frame: 3 hours after the block

    Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).

  15. Presence of quadriceps motor block (defined as paralysis or paresis).

    Time frame: 24 hours after the block

    Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).

  16. Hip adduction strength.

    Time frame: 3 hours after the block

    Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.

  17. Hip adduction strength.

    Time frame: 6 hours after the block

    Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.

  18. Hip adduction strength.

    Time frame: 24 hours after the block

    Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.

  19. Block-related complications

    Time frame: 1 hour after the block

    vascular puncture, paresthesia or systemic local anesthetic toxicity

  20. Postoperative opioid related side effects

    Time frame: 48 hours after the block

    Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression

  21. Inability to perform physiotherapy due to motor block

    Time frame: Postoperative day 1

    Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to decreased strength in the operated leg.

  22. Inability to perform physiotherapy due to motor block

    Time frame: postoperative day 2

    Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to decreased strength in the operated leg.

  23. Inability to perform physiotherapy due to pain

    Time frame: postoperative day 1

    Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to pain in the operated leg.

  24. Inability to perform physiotherapy due to pain

    Time frame: postoperative day 2

    Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to pain in the operated leg.

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

A Randomized Comparison Between Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Pericapsular Nerve Group Block For Total Hip Replacement

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 26, 2020
Registry last updated
Sep 28, 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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