Perineural Dexamethasone for Continuous Femoral Nerve Block

Study Overview
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Brief Summary
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An alternative to improve the quality of postoperative analgesia is to use various perineural adjuvants applicable to peripheral nerve block along with local anesthetics to increase the analgesic effect. Dexamethasone is a strong and long-acting corticosteroid, which reduces postoperative nausea and vomiting and increases the duration of nerve blockade. Most of the existing clinical studies compared the analgesic effect with the placebo group after adding an adjuvant in a single shot nerve block, and there were very few cases of comparing the analgesic effect with the placebo group after adding the adjuvant in peripheral nerve block through continuous catheter infusion. Therefore, we designed this study to investigate whether the use of dexamethasone as a peripheral adjuvant for continuous femoral nerve block has a better pain and recovery profile.

Official Title
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Analgesic Effect of Dexamethasone as a Perineural Adjuvant for Continuous Femoral Nerve Block After Total Knee Arthroplasty: a Prospective Randomized Placebo-controlled Trial

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Procedure: dexamethasone group
* Procedure: sham group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty ASA PS 1-3 Exclusion Criteria: Revision total hip arthroplasty Allergy to drugs used in the study Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal) Estimated glomerular filtration rate < 30 mL/min/1.73m2 Opioid dependence Prolongation of PT and aPTT more than twice the upper limit of normal Pre-existing neurological or anatomical disorders of the lower extremities Serious psychiatric disorders

Ages Eligible for Study
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Minimum Age: 19 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexamethasone group<br>a iliopsoas plane block before surgery | Procedure: dexamethasone group<br>* 1) Arm l (dexamethasone group) Ultrasound-guided femoral nerve block with 1% lidocaine 15 ml after the end of surgery Postoperative femoral nerve patient controlled analgesia Total volume 250 ml (0.375% ropivacaine 60 ml + normal saline 188 ml + dexamethasone 10 mg (2 ml)) Basal rate 4 mL/hr, Bolus volume 2 mL, Lock-out time 15 min<br>|
| Sham Comparator: sham group<br>sham block before surgery | Procedure: sham group<br>* 2) Arm ll (sham group) Ultrasound-guided femoral nerve block with 1% lidocaine 15 ml after the end of surgery Postoperative femoral nerve patient controlled analgesia Total volume 250 ml (0.375% ropivacaine 60 ml + normal saline 190 ml Basal rate 4 mL/hr, Bolus volume 2 mL, Lock-out time 15 min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Numeric rating scale pain score at movement | Pain intensity at movement will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) postoperative 1 hour, postoperative 6 hours, postoperative day 1, postoperative day 2. Maximum Numeric rating scale pain score was determined based on highest score among repeated assessment of surgical site pain severity postoperatively. | within postoperative day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating scale pain score at rest | Pain intensity at rest will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) postoperative 1 hour, postoperative 6 hours, postoperative day 1, postoperative day 2. | up to postoperative day 2 | 
| Numeric rating scale pain score at movement | Pain intensity during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) postoperative 1 hour, postoperative 6 hours, postoperative day 1, postoperative day 2. | up to postoperative day 2 | 
| Postoperative opioid consumption | morphine equivalent dose | up to postoperative day 2 |