Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Suprainguinal Fascia Iliaca Block Versus PENG Block for Hip Arthroplasty Analgesia

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04402450
Recruitment Status : Completed
First Posted : May 26, 2020
Last Update Posted : June 21, 2021
Sponsor:
Information provided by (Responsible Party):
Julian Aliste, University of Chile

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Complications Postoperative Pain Weakness, Muscle Motor Activity Procedure: Ultrasound-guided suprainguinal fascia iliaca nerve block Procedure: Ultrasound-guided pericapsular nerves group of the hip block Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective randomized comparison between two analgesic techniques
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Comparison Between Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Pericapsular Nerve Group Block For Total Hip Replacement
Actual Study Start Date : August 31, 2020
Actual Primary Completion Date : May 25, 2021
Actual Study Completion Date : May 28, 2021

Arm Intervention/treatment
Active Comparator: suprainguinal fascia iliaca block
Forty mL of levobupivacaine 0.25% with epinephrine 5 ug/mL will be injected cranial to the inguinal ligament between the fascia iliaca and the iliopsoas muscle.
Procedure: Ultrasound-guided suprainguinal fascia iliaca nerve block
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.

Experimental: Pericapsular nerve group block
Twenty mL of levobupivacaine 0.5% with epinephrine 5 ug/mL will be deposited in the anterior aspect of the iliac bone between its periosteum and the tendon of the iliopsoas muscle.
Procedure: Ultrasound-guided pericapsular nerves group of the hip block
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 Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04402450


Locations
Layout table for location information
Chile
Hospital Clínico Universidad de Chile
Santiago, Metropolitan, Chile, 8380456
Sponsors and Collaborators
University of Chile
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Julian Aliste, Assistant Professor, University of Chile
ClinicalTrials.gov Identifier: NCT04402450    
Other Study ID Numbers: OAIC 1111/20
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: June 21, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: unidentified data can be shared upon reasonable request after study publication

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Weakness
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Nervous System Diseases