Periarticular Infiltration of Local Anesthetics Versus Pericapsular Nerve Group Block for Total Hip Replacement
- Conditions
- Weakness, MusclePostoperative PainAnalgesiaMotor Activity
- Interventions
- Procedure: Ultrasound-guided pericapsular nerves group of the hip blockProcedure: Pericapsular local anesthetic infiltration of the hip
- Registration Number
- NCT05087862
- Lead Sponsor
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Age between 18 and 80 years
- American Society of Anesthesiologists classification 1-3
- Body mass index between 20 and 35 (kg/m2)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pericapsular nerve group block Ultrasound-guided pericapsular nerves group of the hip 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. Periarticular local anesthetic infiltration Pericapsular local anesthetic infiltration of the hip 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Presence of quadriceps motor block (defined as paralysis or paresis) 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).
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)
Length of hospital stay 7 days after surgery Length of hospital stay after surgery
Readiness to discharge 4 days after surgery Days to be ready for discharge following physiotherapist criteria
Postoperative morphine consumption 48 hours after PACU arrival Consumption of intravenous morphine (mg) registered by a patient-controlled analgesia device.
Inability to perform physiotherapy due to pain 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.
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)
Hip adduction strength 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.
Time until first morphine demand 48 hours after PACU arrival Time (minutes) until first patient-controlled analgesia morphine demand.
Inability to perform physiotherapy due to motor block 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.
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)
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)
Trial Locations
- Locations (1)
Hospital Clínico Universidad de Chile
🇨🇱Santiago, Metropolitan, Chile