The Effect of Adjuvant Dexamethasone on Postoperative Pain, Analgesic Consumption and Block Properties in SFIB

Study Overview
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Brief Summary
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The investigators aimed to demonstrate that dexamethasone added as an adjuvant to local anaesthetic agent in suprainguinal fascia iliaca block for effective postoperative analgesia after knee arthroplasty would prolong the duration of sensory block and reduce postoperative pain intensity and analgesic consumption.

Detailed Description
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Total knee arthroplasty is one of the major orthopedic surgeries that cause severe postoperative pain. A successful post-operative outcome is possible with strong and effective pain control followed by early mobilization and a good functional recovery. Suprainguinal fascia iliaca plan block (SFIB) has been shown to be an effective postoperative method in multimodal analgesia regime in lower extremity surgery. It has been reported in the literature that dexamethasone added to local anaesthetics in peripheral nerve blocks prolongs the duration of sensory block, improves the quality of analgesia, reduces postoperative pain intensity and opioid consumption. In this study, the investigators aimed to demonstrate that dexamethasone added as an adjuvant to local anaesthetic agent in SFIB for effective postoperative analgesia after knee arthroplasty would prolong the duration of sensory block and reduce postoperative pain intensity and analgesic consumption. An identification number will be randomly assigned to each participants, whose written consent was obtained before the surgery, when they are admitted to the postoperative recovery room. In the postoperative period, participants will be followed up with these numbers. Which group the participants will be included in will be determined by the closed envelope method. Participants undergoing unilateral knee arthroplasty will be included in the study. Following the end of surgery, the participants will be divided into two groups in the recovery room and SFIB will be applied to both groups. Participants in group SFIB will receive 0.25% bupivacaine as local anaesthetic. Participants in group SFIB+dexamethasone will receive 0.25% bupivacaine as local anaesthetic and 8 mg dexamethasone as adjuvant. The participant with the block will be followed in the recovery room and if the block is successful, morphine patient controlled analgesia (PCA) treatment will be started and the participant will be taken to the ward. A standard analgesia regimen (1 g iv paracetamol every 8 hours, 50 mg iv dexketoprofen every 12 hours) was used in all participants. Evaluation of postoperative pain will be done with numerical rating scale (NRS). Pain levels will be questioned in two different ways as rest and passive moving.

Official Title
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The Effect of Adjuvant Dexamethasone on Postoperative Pain, Analgesic Consumption and Block Properties in Suprainguinal Fascia Iliaca Block (SFIB) in Knee Arthroplasty

Conditions
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Regional Anesthesia

Intervention / Treatment
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* Procedure: Suprainguinal fascia iliaca block
* Procedure: Suprainguinal fascia iliaca block+dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having undergone unilateral knee replacement surgery under elective conditions, Age range of 18-75 years, American Society of Anesthesiologist's physiologic state I-III patients, written consent who agreed to participate in the study. Exclusion Criteria: BMI>35 who do not want to be included in the study by not signing the voluntary consent form, Local infection, hematoma, hernia, neoplasm etc. in the area to be blocked. found, Coagulopathy, hepatic or renal failure, Allergic to a local anesthetic agent or one of the drugs used in the study, Having a history of chronic opioid and corticosteroid use, who cannot use the patient-controlled analgesia system and have a psychiatric disease, with operative time less than 20 minutes and more than 120 minutes for better standardization of studies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group SFIB (Suprainguinal fascia iliaca block)<br>In the patient lying in the supine position, a high-frequency linear probe is inserted under sterile conditions, using an in-plane technique, 1 cm cephalad of the inguinal ligament with a needle. Using hydro-dissection, the fascia iliaca is separated from the iliac muscle and a space is created where the needle can be advanced cranially, and the procedure will be completed by injecting local anesthetic into this space. | Procedure: Suprainguinal fascia iliaca block<br>* After the operation is completed, the fascia iliaca will be separated from the iliacus muscle. With ultrasound guidance, the local anesthetic injection will be made between the fascia and the muscle.<br>|
| Active Comparator: Group SFIB+dexa (Suprainguinal fascia iliaca block+dexamethasone)<br>In the patient lying in the supine position, a high-frequency linear probe is inserted under sterile conditions, using an in-plane technique, 1 cm cephalad of the inguinal ligament with a needle. Using hydro-dissection, the fascia iliaca is separated from the iliac muscle and a space is created where the needle can be advanced cranially, and the procedure will be completed by injecting local anesthetic+dexamethasone into this space. | Procedure: Suprainguinal fascia iliaca block+dexamethasone<br>* After the operation is completed, the fascia iliaca will be separated from the iliacus muscle. With ultrasound guidance, the local anesthetic+dexamethasone injection will be made between the fascia and the muscle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption | First 24 hours total morphine consumption with patient controlled analgesia | Postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale | To determine the pain of the patients at rest and passive-active moving at the 1st, 3rd, 6th, 12th, 18th and 24th hours postoperatively with Numerical Rating Scale (NRS).The NRS is a segmented numerical version in which the respondent selects an integer (0-10) that best reflects the intensity of their pain. 0: no pain 1-3: mild pain 4-6: moderate pain 7-10: severe pain. | Postoperative 24 hours | 
| Timed up and go test (TUG) | TUG- evaluation of the time in seconds for the patient to get up from the chair and walk 3 meters and return to the chair again | at 24th hour | 
| Quadriceps muscle strength | will be evaluated in a scale between 1-5 (1:lowest; 5:normal) | at 24th hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regional anesthesia, suprainguinal fascia iliaca block, dexamethasone