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Periarticular Infiltration of Local Anesthetics Versus Pericapsular Nerve Group Block for Total Hip Replacement

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ClinicalTrials.gov Identifier: NCT05087862
Recruitment Status : Recruiting
First Posted : October 21, 2021
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
Julian Aliste, University of Chile

Brief Summary:

This randomized trial is set out to compare the postoperative strength preservation capacity of local infiltration anesthesia (LIA) and pericapsular nerve group (PENG) block after performing a primary total hip arthroplasty (THA).

The hypothesis is that LIA represents a superior alternative to PENG block in terms of strength preservation but providing effective analgesia during the first 24 postoperative hours after THA. Hence, the trial was designed as a superiority study hypothesizing a fivefold reduction in quadriceps paresis/paralysis at 3 hours.


Condition or disease Intervention/treatment Phase
Postoperative Pain Weakness, Muscle Analgesia Motor Activity Procedure: Ultrasound-guided pericapsular nerves group of the hip block Procedure: Pericapsular local anesthetic infiltration of the hip Not Applicable

Detailed Description:

Patients who agree to participate in the protocol will be assigned to one group or another (LIA and PENG) through computationally generated block randomization. Outcome assessors blinded to randomization will perform all measurements.

All blocks, LIA or PENG, will be performed (or supervised) by one of the co-authors, an expert orthopedic surgeon or an expert anesthesiologist, respectively. Both blocks will be executed in the operating room, on the surgical table, under sedation, and with the barrier that separates the surgical field from the cranial area of the patient to keep the latter blind to the technique received.

All patients will undergo spinal anesthesia using 0.5% bupivacaine (10mg) plus 20 μg of fentanyl. Both groups will also receive tranexamic acid 1g intravenous (IV), ketoprofen 100mg IV, and acetaminophen 1gr IV. Propofol sedation guided with a targeted controlled infusion (TCI) model will be administered in order to obtain an adequate level of sedation.

All surgeries will be conducted by the same team of surgeons, performing a posterior approach technique in the lateral decubitus position.

In the recovery room, all patients will receive patient-controlled analgesia (morphine bolus = 1 mg; lockout interval = 8 minutes). On the surgical ward, all subjects will continue to receive acetaminophen (1 g per os every 6 hours), ketoprofen (100 mg per os every 8 hours) as well and patient-controlled analgesia (morphine bolus = 1 mg IV; lockout interval = 8 minutes).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized comparison between two analgesic techniques
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Comparison Between Periarticular Infiltration of Local Anesthetics and Ultrasound-Guided Pericapsular Nerve Group Block for Total Hip Replacement
Actual Study Start Date : November 5, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pericapsular nerve group block
Twenty milliliters of bupivacaine 0.5% (100 milligrams) 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. Additionally, ketorolac 30 mg will be administered intravenously.
Procedure: Ultrasound-guided pericapsular nerves group of the hip block
After the ultrasound-guided insertion of a block needle at the level of the inguinal ligament, the needle will be advance into the plane between the iliac bone periosteum and the tendon of the iliopsoas muscle in order to inject 20 mL of adrenalized 0.5% bupivacaine.

Experimental: Periarticular local anesthetic infiltration
Sixty milliliters of 0.25% bupivacaine (150 milligrams), 5ug/mL epinephrine, and ketorolac 30 mg will be deposited at the periarticular level under direct vision during surgery. Fascia, subcutaneous tissues, and skin will also be infiltrated with part of the solution before wound closure.
Procedure: Pericapsular local anesthetic infiltration of the hip
Intraoperatively, 60 mL of adrenalized 0.25% bupivacaine plus ketorolac 30 mg will be infiltrated by the surgeon.




Primary Outcome Measures :
  1. Presence of quadriceps motor block (defined as paralysis or paresis) [ Time Frame: 3 hours after post anesthesia care unit (PACU) arrival ]
    Quadriceps motor function will be tested with the patient lying on the bed and with the hip joint at 45º and the knee at 90º. 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. Presence of quadriceps motor block (defined as paralysis or paresis) [ Time Frame: 6 hours after PACU arrival ]
    Quadriceps motor function will be tested with the patient lying on the bed and with the hip joint at 45º and the knee at 90º. 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).

  2. Presence of quadriceps motor block (defined as paralysis or paresis) [ Time Frame: 24 hours after PACU arrival ]
    Quadriceps motor function will be tested with the patient lying on the bed and with the hip joint at 45º and the knee at 90º. 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).

  3. Hip adduction strength [ Time Frame: 3 hours after PACU arrival ]
    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% (normal strength), 21-70% (paresis), and 71-90% (paralysis) compared to the baseline measurement, respectively.

  4. Hip adduction strength [ Time Frame: 6 hours after PACU arrival ]
    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% (normal strength), 21-70% (paresis), and 71-90% (paralysis) compared to the baseline measurement, respectively.

  5. Hip adduction strength [ Time Frame: 24 hours after PACU arrival ]
    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% (normal strength), 21-70% (paresis), and 71-90% (paralysis) compared to the baseline measurement, respectively.

  6. Postoperative morphine consumption [ Time Frame: 24 hours after PACU arrival ]
    Consumption of intravenous morphine (mg) registered by a patient-controlled analgesia device.

  7. Postoperative morphine consumption [ Time Frame: 48 hours after PACU arrival ]
    Consumption of intravenous morphine (mg) registered by a patient-controlled analgesia device.

  8. Time until first morphine demand [ Time Frame: 48 hours after PACU arrival ]
    Time (minutes) until first patient-controlled analgesia morphine demand.

  9. Static and dynamic pain [ Time Frame: 3 hours after PACU arrival ]
    Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

  10. Static and dynamic pain [ Time Frame: 6 hours after PACU arrival ]
    Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

  11. Static and dynamic pain [ Time Frame: 12 hours after PACU arrival ]
    Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

  12. Static and dynamic pain [ Time Frame: 18 hours after PACU arrival ]
    Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

  13. Static and dynamic pain [ Time Frame: 24 hours after PACU arrival ]
    Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

  14. Static and dynamic pain [ Time Frame: 48 hours after PACU arrival ]
    Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

  15. Sensory block [ Time Frame: 3 hours after PACU arrival ]
    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)

  16. Sensory block [ Time Frame: 6 hours after PACU arrival ]
    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)

  17. Sensory block [ Time Frame: 24 hours after PACU arrival ]
    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)

  18. Block/Infiltration-related complications [ Time Frame: 1 hour after nerve block or local anesthetic infiltration ]
    Incidence of adverse events related to nerve block or local anesthetic infiltration (i.e. vascular puncture, local anesthetic systemic toxicity)

  19. Postoperative opioid related side effects [ Time Frame: 48 hours after PACU arrival ]
    Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression.

  20. Duration of surgery [ Time Frame: 4 hours after skin incision ]
    Time between skin incision and closure (min)

  21. Inability to perform physiotherapy due to motor block [ Time Frame: 6 hours after PACU arrival ]
    Number of participants that cannot end the physiotherapy protocol programmed for the sixth hour after PACU arrival secondary to decreased strength in the operated limb.

  22. 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 limb.

  23. 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 limb.

  24. Inability to perform physiotherapy due to pain [ Time Frame: 6 hours after PACU arrival ]
    Number of participants that cannot end the physiotherapy protocol programmed for the sixth hour after PACU arrival secondary to pain in the operated limb.

  25. 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 limb.

  26. 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 limb.

  27. Readiness to discharge [ Time Frame: 4 days after surgery ]
    Days to be ready for discharge following physiotherapist criteria

  28. Length of hospital stay [ Time Frame: 7 days after surgery ]
    Length of hospital stay after surgery



Information from the National Library of Medicine

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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 ≤ 100, 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) or morphine
  • Pregnancy
  • Prior surgery in the inguinal area of the corresponding surgical side
  • Previous hip arthroplasty due to hip fracture
  • 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): NCT05087862


Contacts
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Contact: Julián Aliste, MD +56229788221 julian.aliste@uchile.cl

Locations
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Chile
Hospital Clínico Universidad de Chile Recruiting
Santiago, Metropolitan, Chile, 8380456
Contact: Julián Aliste, MD    +56229788221    julian.aliste@uchile.cl   
Sponsors and Collaborators
University of Chile
Investigators
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Principal Investigator: Julián Aliste, MD University of Chile
Publications:

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Responsible Party: Julian Aliste, Assistant Professor, University of Chile
ClinicalTrials.gov Identifier: NCT05087862    
Other Study ID Numbers: OAIC 1169/20
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021
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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Muscle Weakness
Pathologic Processes
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Nervous System Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents