Incidence of Urinary Retention in Patients Undergoing Unilateral Total Knee Arthroplasty- Comparison Between Continuous Epidural Analgesia and Single Shot Femoral Nerve Block- a Randomized Controlled Study (UriKANE)

Study Overview
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Brief Summary
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This study aims to compare the incidence of urinary retention and requirement of bladder catheterization in patients undergoing total knee arthroplasty while receiving either continuous epidural analgesia or single shot femoral nerve block.

Official Title
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Incidence of Urinary Retention in Patients Undergoing Unilateral Total Knee Arthroplasty- Comparison Between Continuous Epidural Analgesia and Single Shot Femoral Nerve Block- a Randomized Controlled Study (UriKANE)

Conditions
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Acute Pain, Urinary Retention, Post Operative Pain

Intervention / Treatment
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* Procedure: Femoral Nerve Block
* Procedure: Epidural


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA Physical status I, II & III Male and Female Patients age between between 30 and 70 years Unilateral Total Knee Arthroplasty Exclusion Criteria: Patient Refusal Allergy to local anesthetics, paracetamol or other study drugs History of opioid dependence Contraindications to spinal/epidural anesthesia and femoral nerve block (coagulation defects, infection at puncture site etc.) Inability to use patient-controlled analgesia (IV PCIA) (as assessed at the time of informed consent) History of urinary retention, neurogenic bladder, or any urologic problem

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group F<br>Femoral nerve Block Group | Procedure: Femoral Nerve Block<br>* For patients in Femoral nerve Block Group (Group F), ultrasound guided Femoral nerve block was performed using 0.375% bupivacaine, 20 ml for femoral nerve<br>|
| Active Comparator: Group E<br>Epidural Group | Procedure: Epidural<br>* Patients in Epidural Group (Group E) were turned in lateral position for epidural catheter placement in lumbar region. Epidural was loaded with 0.25% bupivacaine and infusion of M2 (Bupivacaine 0.1% + Fentanyl 2mcg/ml) was started at 8 - 12 ml per hour.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of urinary retention | To compare the incidence of urinary retention in patients undergoing unilateral Total Knee Arthroplasty receiving continuous epidural analgesia vs. single shot Femoral Nerve Block. | 24 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean post-operative nausea and vomiting scores | To compare the mean post-operative nausea and vomiting scores between the two groups at 0, 1, 12, 24 & 48 hours postoperatively. | up to 48 hours | 
| Mean post-operative sedation scores | To compare the mean post-operative sedation scores between the two groups at 0, 1, 12, 24 & 48 hours postoperatively. | up to 48 hours | 
| Mean post-operative pain scores | To compare the mean post-operative pain scores between the two groups at 0, 1, 12, 24 & 48 hours postoperatively. | up to 48 hours | 
| Surgical outcomes - maximal knee flexion | To compare surgical outcomes like maximal knee flexion at 24 & 48 hours between the two groups | up to 48 hours | 
| Surgical outcomes - duration of post-operative hospital stay | To compare surgical outcomes like duration of post-operative hospital stay between the two groups | up to 48 hours | 
| Surgical outcomes - mobilization out of bed | To compare surgical outcomes like time taken to mobilize out of bed between the two groups | up to 48 hours | 
| Surgical outcomes - food intake | To compare surgical outcomes like time of first food intake between the two groups | up to 48 hours | 
| Patient satisfaction | To compare Patient satisfaction with the analgesic modality between the two groups | 7 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Femoral Nerve Block, Epidural Analgesia, Urinary Retention, Lumbar Epidural