Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement

Study Overview
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Brief Summary
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The nerves from lumbar plexus (LP) are the current target to achieve analgesia after a total hip arthroplasty (THA). Lumbar plexus block (LPB) is an alternative that provides optimal postoperative analgesia. However, many adverse effects and complications have been reported due to its proximity to vital structures. Because of these shortcomings, an alternative to block the LP nerves is required. In a recent trial suprainguinal Fascia Iliaca Block (SFIB) was reported to provide reliable analgesia in THA. SFIB may carry a lower risk profile, however, no study has compared the efficacy of LPB and SFIB in this setting. Thus, this randomized trial is set out to compare US guided LPB and SFIB for analgesia after THA. The hypothesis is that both blocks would result in similar postoperative opioid (morphine) consumption at 24 hours and, therefore, designed the study as an equivalence trial.

Official Title
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A Randomized Comparison Between Ultrasound Guided Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement Analgesia

Conditions
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Hip Osteoarthritis, Pain, Acute, Pain, Postoperative, Opioid Use

Intervention / Treatment
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* Procedure: lumbar plexus block
* Procedure: suprainguinal fascia iliaca block


Participation Criteria
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Eligibility Criteria
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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 ≥ 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 corresponding side of the lumbar o suprainguinal area Chronic pain syndromes requiring opioid intake at home

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lumbar plexus block<br>Patients randomized to receive an ultrasound-guided lumbar plexus block | Procedure: lumbar plexus block<br>* Injection with ultrasound guidance of 40 mL of levobupivacaine 0.25% with 5 micrograms of epinephrine per mL and dexamethasone 4 milligrams, in the posteromedial quadrant of psoas muscle<br>|
| Experimental: Suprainguinal fascia iliaca block<br>Patients randomized to receive an ultrasound-guided suprainguinal fascia iliaca block | Procedure: suprainguinal fascia iliaca block<br>* Injection with ultrasound guidance of 40 mL of levobupivacaine 0.25% with 5 micrograms of epinephrine per mL and dexamethasone 4 milligrams, underneath the fascia iliaca at the suprainguinal level<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption over 24 hours | Total morphine consumption over 24 hours post block | 24 hours post block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance time | Interval between the start of skin disinfection and the end of local anesthetic injection | 2 hours after surgery | 
| Number of needle passes | The initial needle insertion counted as the first pass. Any subsequent needle advancement that is preceded by a retraction of at least 10 mm counts as an additional pass | 2 hours after surgery | 
| Postoperative static pain at 3 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 3 hours after the block | 
| Postoperative static pain at 6 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 6 hours after the block | 
| Postoperative static pain at 12 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 12 hours after the block | 
| Postoperative static pain at 24 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 24 hours after the block | 
| Postoperative dynamic pain at 3 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 3 hours after the block | 
| Postoperative dynamic pain at 6 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 6 hours after the block | 
| Postoperative dynamic pain at 12 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 12 hours after the block | 
| Postoperative dynamic pain at 24 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 24 hours after the block | 
| Postoperative static pain at 48 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 48 hours after the block | 
| Postoperative dynamic pain at 48 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 48 hours after the block | 
| Time until first morphine demand | Time until first patient-controlled analgesia morphine demand | 48 hours after the block | 
| Block assessment at 3 hours | Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves. Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch. Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis. | 3 hours after the block | 
| Block assessment at 6 hours | Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves. Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch. Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis. | 6 hours after the block | 
| Block assessment at 24 hours | Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves. Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch. Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis. | 24 hours after the block | 
| Incidence of block related adverse events | Incidence of adverse events related to nerve block (vascular puncture, local anesthetic systemic toxicity, epidural spread) | 3 hours after block | 
| Incidence of opioid related adverse events | Incidence of adverse events related to opioid use (nausea/vomiting, pruritus, somnolence, respiratory depression) | 48 hours after block | 
| Incidence of Inability to perform physiotherapy | Inability to perform physiotherapy due to pain (score more than 4 in Numeric Rating Score from 0 to 10 points) or motor blockade. | 24 hours after the block | 
| Surgical duration | Time between skin incision and closure | 4 hours | 
| Readiness to discharge | Days to be ready for discharge following physiotherapist criteria | 4 days after surgery | 
| Length of hospital stay | Length of hospital stay after surgery | 7 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nerve block, fascia iliaca, hip replacement, lumbar plexus