Perineural Dexamethasone in the Adductor Canal Block

Study Overview
=================
Brief Summary
-----------------
Postoperative pain management in total knee arthroplasty (TKA) surgery is a real challenge for the anesthesiologist. Effective pain control must be provided while preserving the mobility to ensure early rehabilitation. The adductor canal block is an effective way to induce sensory block without motor block. However, the major disadvantage of this block is the duration of sensory block which may be insufficient for postoperative pain management in TKA surgery. Many studies have focused on finding molecules that can prolong sensory block without the need for a perineural catheter and dexamethasone is among the most studied molecules(1, 2). Hence, our study aims to evaluate the added value of perineural dexamethasone in the adductor canal block in TKA surgery. [

Detailed Description
-----------------
Using a computer-generated sequence of random numbers, the patients included will be randomly allocated to get an adductor canal block using : Group D: 10 ml of 0.5% bupivacaine + 10 ml of 0.9% normal saline solution + 8 mg of dexamethasone (equivalent to 2 ml) Group C: 10 ml of 0.5% bupivacaine + 10 ml of 0.9% normal saline solution + 2 ml of 0.9% normal saline solution All patients included in the study will initially be evaluated at the anesthesia outpatient clinic with correction of any existing health issues. A pre-anesthesia visit will be conducted the day before the procedure for all patients, providing them with information about the protocol of our study and obtaining their consent to participate. Upon arrival at the operating room, non-invasive monitoring of blood pressure, pulse oximetry, and ECG tracing will be performed and also a blood glucose level measurement. An 18-gauge peripheral intravenous line will be established, and 0.03 mg per kg midazolam was administrated. All patients will receive spinal anesthesia. Depending on the patient's condition, investigators will opte for: A single shot spinal anesthesia using 0.5% bupivacaine (11 mg) with fentanyl (25 µg) for patients under 65 years of age with ASA I and II Continuous spinal anesthesia with drug titration for patients over 65 years of age or with ASA III classification. None of patients will receive intravenous dexamethasone during the perioperative period. The decision to use a tourniquet and use of cement will be left to the surgeon. In the immediate postoperative period, all patients will receive an adductor canal block with a high-frequency probe. The patients will be positioned in a supine position with the leg slightly externally rotated. The probe will be placed transversely on the inguinal fold. The femoral vessels (artery and vein) will be identified. The different muscular structures delimiting the adductor canal will be visualized: the sartorius muscle that covers the femoral artery and the medial vastus muscle laterally. The saphenous nerve, which is usually hyperechoic, is located most often at the lateral edge of the artery in the fascia between the sartorius and medial vastus muscles. A 100 mm neurostimulation needle was used and 22 ml solution was injected into the adductor canal. Patients will be transferred to continuous care unit for 48 hours. Post operative analgesia will include: Paracetamol 1g IV every 6 hours for 1 day then oral paracetamol 1g every 8 hours for 4 weeks Diclofenac sodium (50 mg) *2 per day for 5 days PCA morphine (Patient Controlled Analgesia), as a rescue analgesia. The first rise will be allowed on day 1 (18 h postoperatively) and the patient will be asked to wander with a walking frame for a distance of at least 3 meters (about 10 steps). The patient will be considered ready for discharge after completing protocol endpoints and walking at least 3 meters without support.

Official Title
-----------------
Perineural Dexamethasone in the Adductor Canal Block for Postoperative Pain in Knee Arthroplasty Surgery

Conditions
-----------------
Post Operative Pain

Intervention / Treatment
-----------------
* Procedure: group Dexamethasone
* Procedure: group Controle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for unilateral TKA Surgery under spinal anesthesia ASA class I, II, and III patients Exclusion Criteria: Patient refusal to participate in the study Contraindication to regional anesthesia Allergies to the products used Bilateral TKA Revision TKA TKA in the context of inflammatory or post-traumatic disease BMI > 45 Poorly controlled diabetic patients with HbA1c > 8% Patients on corticosteroid therapy or who have received an intra-articular injection of corticosteroids
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group Dexamethasone<br>adductor canal block with 10 ml of 0.5% bupivacaine + 10 ml of 0.9% saline solution + 2 ml of dexamethasone (8 mg) | Procedure: group Dexamethasone<br>* Adductor canal block with dexamethasone<br>|
| Active Comparator: group Controle<br>adductor canal block with 10 ml of 0.5% bupivacaine + 10 ml of 0.9% saline solution + 2 ml of 0.9% saline solution | Procedure: group Controle<br>* Adductor canal block with saline solution<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption | postoperative consumption of morphine | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS at rest | Numerical rate scale at rest [ NRS =0 no pain ; NRS =10 worse pain] | 1 hour, 3 hours, 6 hours, 9 hours,12 hours, 24 hours, 36 hours and 48 hours postoperatively | 
| NRS on mouvement | Numerical rate scale during knee flexion [ NRS =0 no pain ; NRS =10 worse pain] | 1 hour, 3 hous, 6 hours, 9 hours,12 hours, 24 hours, 36 houes and 48 hours postoperatively | 
| knee mouvement | Range of mouvement of the knee | preoperatively, on day 1 and day 7 postoperatively | 
| walk | Numbers of steps | day 1 and day 2 postoperatively | 
| Patient's satisfaction | 3 level scale :0: not satisfied; 1: mild satisfaction; 2: satisfied | 48 hours postoperatively | 
| Blood glucose level | Blood glucose level | 1 hour, 6 hours,12 hours,18 hours, 24 hours postoperatively | 
| pain at home | NRS at mouvement [ NRS =0 no pain ; NRS =10 worsE pain] | 7 days postoperatively | 
| quality of recovery | QoR15 score [ 136-150 excellent recovery - 0-89 poor recovery] | day one | 
| neuropathic Chronic pain | DN4 questionnaire [ no neuropathic pain 0 - neuropathic pain >4] | 6 MONTHS | 
| chronic pain | NRS on mouvement [ NRS =0 no pain ; NRS =10 worse pain] | 6 months | 
| postoperative quality of life | SF-12 score [0 to 100, with higher scores indicating better physical and mental health functioning] | 6 months | 
| knee fonction | KOOS PS score [[0 to 100, with higher scores indicating better knee function]functioning] | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee arthroplasty, glucocorticoids, adductor canal block