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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
60
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.
Intraoperatively, 60 mL of adrenalized 0.25% bupivacaine plus ketorolac 30 mg will be infiltrated by the surgeon.
Hospital Clínico Universidad de Chile
Santiago, Metropolitan, Chile
Presence of quadriceps motor block (defined as paralysis or paresis)
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).
Time frame: 3 hours after post anesthesia care unit (PACU) arrival
Presence of quadriceps motor block (defined as paralysis or paresis)
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).
Time frame: 6 hours after PACU arrival
Presence of quadriceps motor block (defined as paralysis or paresis)
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).
Time frame: 24 hours after PACU arrival
Hip adduction strength
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.
Time frame: 3 hours after PACU arrival
Hip adduction strength
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.
Time frame: 6 hours after PACU arrival
Hip adduction strength
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.
Time frame: 24 hours after PACU arrival
Postoperative morphine consumption
Consumption of intravenous morphine (mg) registered by a patient-controlled analgesia device.
Time frame: 24 hours after PACU arrival
Postoperative morphine consumption
Consumption of intravenous morphine (mg) registered by a patient-controlled analgesia device.
Time frame: 48 hours after PACU arrival
Time until first morphine demand
Time (minutes) until first patient-controlled analgesia morphine demand.
Time frame: 48 hours after PACU arrival
Static and dynamic pain
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)
Time frame: 3 hours after PACU arrival
Static and dynamic pain
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)
Time frame: 6 hours after PACU arrival
Static and dynamic pain
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)
Time frame: 12 hours after PACU arrival
Static and dynamic pain
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)
Time frame: 18 hours after PACU arrival
Static and dynamic pain
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)
Time frame: 24 hours after PACU arrival
Static and dynamic pain
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)
Time frame: 48 hours after PACU arrival
Sensory 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)
Time frame: 3 hours after PACU arrival
Sensory 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)
Time frame: 6 hours after PACU arrival
Sensory 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)
Time frame: 24 hours after PACU arrival
Block/Infiltration-related complications
Incidence of adverse events related to nerve block or local anesthetic infiltration (i.e. vascular puncture, local anesthetic systemic toxicity)
Time frame: 1 hour after nerve block or local anesthetic infiltration
Postoperative opioid related side effects
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression.
Time frame: 48 hours after PACU arrival
Duration of surgery
Time between skin incision and closure (min)
Time frame: 4 hours after skin incision
Inability to perform physiotherapy due to motor block
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.
Time frame: 6 hours after PACU arrival
Inability to perform physiotherapy due to motor block
Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to decreased strength in the operated limb.
Time frame: Postoperative day 1
Inability to perform physiotherapy due to motor block
Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to decreased strength in the operated limb.
Time frame: Postoperative day 2
Inability to perform physiotherapy due to pain
Number of participants that cannot end the physiotherapy protocol programmed for the sixth hour after PACU arrival secondary to pain in the operated limb.
Time frame: 6 hours after PACU arrival
Inability to perform physiotherapy due to pain
Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to pain in the operated limb.
Time frame: Postoperative day 1
Inability to perform physiotherapy due to pain
Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to pain in the operated limb.
Time frame: Postoperative day 2
Readiness to discharge
Days to be ready for discharge following physiotherapist criteria
Time frame: 4 days after surgery
Length of hospital stay
Length of hospital stay after surgery
Time frame: 7 days after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.