Total Periarticular Infiltration Vs Posterior Periarticular Infiltration Plus PENG Block for Hip Analgesia

Sponsor

University of Chile (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06075004

Collaborator

(none)

Enrollment

Location

Arms

12.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In a recent study, direct periarticular local anesthetic infiltration (PAI) showed a greater incidence of early quadriceps weakness (33% at 3 hours and 13% at 6 hours) than pericapsular nerve group block (PENGB) in total hip arthroplasty (THA) but, in turn, demonstrated a statistically significant better pain control. Additionally, PENGB could not completely circumvent motor compromise either, particularly at 3 hours (20% incidence), probably secondary to an injectate migration towards the femoral nerve. Posteriorly to this publication, a cadaveric trial looking into the maximum effective volume that spared the femoral nerve resulted in 13.2 mL.

This newer evidence led to the design of a strategy that combines both interventions, aiming to obtain the best of them and have a solid alternative for those cases where very early mobilization is pursued.

Thus, it is hypothesized that posterior PAI added to a low-volume PENGB (10mL) represents a superior alternative to PAI in terms of strength preservation and provides effective analgesia during the first 24 postoperative hours after THA.

Condition or Disease	Intervention/Treatment	Phase
Hip Osteoarthritis Postoperative Pain	Procedure: Periarticular Local Anesthetic Infiltration Procedure: Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block	N/A

Detailed Description

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

All trial interventions (PAI or posterior PAI+PENGB) will be performed (or supervised) by one of the co-authors, an expert orthopedic surgeon anesthesiologist. Both interventions 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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective randomized comparison between two analgesic techniquesProspective randomized comparison between two analgesic techniques

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized Comparison Between Total Periarticular Anesthetic Infiltration and Partial Posterior Periarticular Anesthetic Infiltration Plus Low Volume Ultrasound-Guided Pericapsular Nerve Group Block for Total Hip Replacement Analgesia

Anticipated Study Start Date :

Oct 13, 2023

Anticipated Primary Completion Date :

Oct 15, 2024

Anticipated Study Completion Date :

Oct 23, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Periarticular Local Anesthetic Infiltration 60 mL of 0.25% bupivacaine with 5ug/mL epinephrine will be deposited under direct vision during surgery at the periarticular level before wound closure.	Procedure: Periarticular Local Anesthetic Infiltration Sixty milliliters of 0.25% bupivacaine + 5ug/mL epinephrine and ketorolac 30 mg will be deposited by the orthopedic surgeon 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.
Experimental: Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block 45 mL of 0.25% bupivacaine with 5ug/mL epinephrine will be deposited under direct vision during surgery at the posterior periarticular level before wound closure. After wound closure, an ultrasound-guided pericapsular nerve group block of the hip will be performed using ten mL of 0.5% bupivacaine with 5ug/mL epinephrine.	Procedure: Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block From a total of forty-five milliliters of 0.25% bupivacaine + 5ug/mL epinephrine and ketorolac 30 mg, 15mL will be deposited by the orthopedic surgeon at the posterior periarticular level under direct vision during surgery. Fascia, subcutaneous tissues, and skin will also be infiltrated with part of the solution before wound closure with the remaining 30mL. After wound closure, an ultrasound-guided pericapsular nerve group block will be performed by an anesthesiologist by injecting 10mL of 0.5% bupivacaine + 5ug/mL epinephrine in the plane between the iliac bone periosteum and the tendon of the iliopsoas muscle.

Arm

Intervention/Treatment

Active Comparator: Periarticular Local Anesthetic Infiltration

60 mL of 0.25% bupivacaine with 5ug/mL epinephrine will be deposited under direct vision during surgery at the periarticular level before wound closure.

Procedure: Periarticular Local Anesthetic Infiltration

Sixty milliliters of 0.25% bupivacaine + 5ug/mL epinephrine and ketorolac 30 mg will be deposited by the orthopedic surgeon 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.

Experimental: Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block

45 mL of 0.25% bupivacaine with 5ug/mL epinephrine will be deposited under direct vision during surgery at the posterior periarticular level before wound closure. After wound closure, an ultrasound-guided pericapsular nerve group block of the hip will be performed using ten mL of 0.5% bupivacaine with 5ug/mL epinephrine.

Procedure: Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block

From a total of forty-five milliliters of 0.25% bupivacaine + 5ug/mL epinephrine and ketorolac 30 mg, 15mL will be deposited by the orthopedic surgeon at the posterior periarticular level under direct vision during surgery. Fascia, subcutaneous tissues, and skin will also be infiltrated with part of the solution before wound closure with the remaining 30mL. After wound closure, an ultrasound-guided pericapsular nerve group block will be performed by an anesthesiologist by injecting 10mL of 0.5% bupivacaine + 5ug/mL epinephrine in the plane between the iliac bone periosteum and the tendon of the iliopsoas muscle.

Outcome Measures

Primary Outcome Measures

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

Presence of quadriceps motor block (defined as paralysis or paresis) [6 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).
Presence of quadriceps motor block (defined as paralysis or paresis) [24 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).
Hip adduction strength [3 hours after post anesthesia care unit (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.
Hip adduction strength [6 hours after post anesthesia care unit (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.
Hip adduction strength [24 hours after post anesthesia care unit (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.
Postoperative morphine consumption [24 hours after PACU arrival]
Consumption of intravenous morphine (mg) registered by a patient-controlled analgesia device.
Postoperative morphine consumption [48 hours after PACU arrival]
Consumption of intravenous morphine (mg) registered by a patient-controlled analgesia device.
Time until first morphine demand [48 hours after PACU arrival]
Time (minutes) until first patient-controlled analgesia morphine demand.
Static and dynamic pain [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).
Static and dynamic pain [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).
Static and dynamic pain [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).
Static and dynamic pain [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).
Static and dynamic pain [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).
Static and dynamic pain [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).
Sensory block [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).
Sensory block [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).
Sensory block [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).
Block/Infiltration-related complications [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).
Postoperative opioid related side effects [48 hours after PACU arrival]
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression.
Duration of surgery [4 hours after skin incision]
Time between skin incision and closure (min).
Inability to perform physiotherapy due to motor block [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.
Inability to perform physiotherapy due to motor block [Postoperative day 1]
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.
Inability to perform physiotherapy due to motor block [Postoperative day 2]
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.
Inability to perform physiotherapy due to pain [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.
Inability to perform physiotherapy due to pain [Postoperative day 1]
Number of participants that cannot end the physiotherapy protocol programmed for the sixth hour after PACU arrival secondary to pain in the operated limb.
Inability to perform physiotherapy due to pain [Postoperative day 2]
Number of participants that cannot end the physiotherapy protocol programmed for the sixth hour after PACU arrival secondary to pain in the operated limb.
Readiness to discharge [4 days after surgery]
Days to be ready for discharge following physiotherapist criteria
Length of hospital stay [7 days after surgery]
Length of hospital stay after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 ≥ 1.4 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 corresponding surgical side
Chronic pain syndromes requiring opioid intake at home