Motor Activity, Postoperative Complications, Postoperative Pain, Weakness, Muscle
Conditions
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.
Interventions
PROCEDUREUltrasound-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.
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.
Sponsors
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
prospective randomized comparison between two analgesic techniques
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of quadriceps motor block (defined as paralysis or paresis). | 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
| Measure | Time frame | Description |
|---|---|---|
| Static and dynamic pain | 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) |
| Postoperative morphine consumption | 24 hours after the block | consumption of intravenous morphine registered by a patient controlled analgesia device |
| Sensory block | 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) |
| Presence of quadriceps motor block (defined as paralysis or paresis). | 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). |
| Block performance time | 1 hour after surgery | temporal interval between the start of skin disinfection and the end of LA injection through the block needle |
| Block-related complications | 1 hour after the block | vascular puncture, paresthesia or systemic local anesthetic toxicity |
| Postoperative opioid related side effects | 48 hours after the block | Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression |
| Inability to perform physiotherapy due to motor block | 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. |
| Inability to perform physiotherapy due to pain | 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. |
| Hip adduction strength. | 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. |
Countries
Chile
Outcome results
None listed