Concentration Effect of Local Anesthetics on Femoral Nerve Block Efficiency

Study Overview
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Brief Summary
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US-guided femoral nerve block is used effectively in post-operative pain management in the surgical treatment of the lower extremity. However, the volume and concentration of the local anesthetic drug to be administered remains controversial. In this prospective, randomized, double-blinded study, patients who underwent unilateral primary total knee arthroplasty and successfully performed spinal anesthesia with standard method and dosage, will be selected for US-guided femoral nerve block after the operation. Patients will be divided into three groups with simple randomization. The First group will be determined as the control group (GCont) and only dressing will be applied to the patients. For second group(G125), 0,125% 20 ml local anesthetic and for the third group (G25), 0,25% 10 ml local anesthetic will be administered to the femoral nerve without changing the drug dose (25 mg bupivacaine). Whether there is a difference between post-op analgesia durations, motor block formation, mobilization time and 90° flexion time between the groups will be investigated.

Detailed Description
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All patients scheduled for total knee arthroplasty will be evaluated before the operation. Eligible patients will be informed about the study and Numeric Rating Scale for pain evaluation. Then, patients will be asked for informed consent. After approval from the local research ethics committee, first patient will be recruited for study and patient's group will be determined by dice roll(1,4: GCont - 2,5: G125 - 3,6: G25). Patients who are scheduled for primary total knee arthroplasty under spinal anesthesia with a planned sensory block level between T4 and T7 dermatomes, will be recruited and assigned to a group. After successfully completed surgery, patients will be administered femoral nerve block or only dressing according to the relevant group. Before femoral nerve block is performed, patients will be re-informed about Numeric Rating Scale(NRS) and will be asked to rate their pain at the moment. Control Group(GCont) patients will only be applied sterile dressing for the purpose of blinding the patient and the follow-up physician. 0.125% Bupivacaine Group(G125) patients will be administered femoral block with 20 ml 0.125% Bupivacaine by an experienced anesthesiologist. 0.25% Bupivacaine Group(G25) patients 10ml will be administered femoral block with 0.25% Bupivacaine by an experienced anesthesiologist. The procedures will be performed in the operating room under both US and nerve stimulator guidance. Patients will be followed-up in post-anesthesia care unit and in the ward for 48 hours. Scheduled and on-demand(Tramadol) medication for analgesia will be ordered and nurses will be informed about the study. Patients' pain scores and ambulation times will be followed-up by another anesthesiologist and on-demand medication will be recorded and monitored from hospital's computer based hospital management program online. Patients will be followed-up for six months after the surgery in order to explore potential long term benefits and complications.

Official Title
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Concentration-Volume Relationship of Bupivacaine in Femoral Nerve Block Efficiency for Postoperative Analgesia in Primary Total Knee Arthroplasty: A Randomized Controlled Double Blind Clinical Trial

Conditions
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Anesthesia, Conduction, Arthroplasty, Replacement, Knee, Pain, Postoperative, Anesthesia and Analgesia

Intervention / Treatment
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* Procedure: Ultrasound Guided Femoral Nerve Block
* Other: Dressing
* Drug: Bupivacaine 0.25% Injectable Solution
* Drug: Bupivacaine 0.125% Injectable Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are scheduled for primary unilateral total knee arthroplasty under spinal anesthesia Patients who has informed consent for study Exclusion Criteria: Patient's refusal to participate Patients under 18 years of age Patients who are undergoing surgery with an anesthesia technique other than spinal anesthesia for any reason (general anesthesia, laryngeal mask application, etc.) Patients with known local anesthetic allergy Patients with Body mass index > 35 Patients diagnosed sepsis and bacteriemia, Skin infection at the injection site, History of coagulopathy or anticoagulant therapy Patients with uncontrolled diabetes , Uncoordinated patients, Psychological and emotional lability, Surgical intervention longer than 3 hours. Patients with pre-operative limitation of movement

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Three groups involved. One control group and two nerve block groups with different drug concentration
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: GCont<br>Only dressing will be applied to patients without actually nerve block performed | Other: Dressing<br>* Only dressing will be applied to related area to protect blindness between groups<br>|
| Active Comparator: G125 Block<br>Ultrasound Guided Femoral Nerve Block: 20ml Bupivacaine 0.125% Injectable Solution will be administered for femoral nerve block. 5ml %0,5 Bupivacaine will be diluted with 15ml Saline solution. | Procedure: Ultrasound Guided Femoral Nerve Block<br>* Femoral nerve block will be applied post-operatively with guidance of USG and nerve stimulator<br>* Other names: Regional Anesthesia;Drug: Bupivacaine 0.125% Injectable Solution<br>* Perineural Injection<br>* Other names: Marcain;|
| Active Comparator: G25 Block<br>Ultrasound Guided Femoral Nerve Block: 10ml Bupivacaine 0.25% Injectable Solution will be administered for femoral nerve block. 5ml %0,5 Bupivacaine will be diluted with 5ml Saline solution. | Procedure: Ultrasound Guided Femoral Nerve Block<br>* Femoral nerve block will be applied post-operatively with guidance of USG and nerve stimulator<br>* Other names: Regional Anesthesia;Drug: Bupivacaine 0.25% Injectable Solution<br>* Perineural Injection<br>* Other names: Marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 30th minute postoperatively | 
| Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 1st hour postoperatively | 
| Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 2nd hour postoperatively | 
| Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 6th hour postoperatively | 
| Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 12th hour postoperatively | 
| Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 24th hour postoperatively | 
| Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 48th hour postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulation Time | First time a patients can walk around independently | 72 hours post-operatively | 
| Opioid Consumption | Opioids(Tramadol) will be administered to patients in case demanded. | 48 hour post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoral nerve block, peripheral nerve block, Concentration, volume, bupivacaine, post operative analgesia, total knee arthroplasty