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) (UriKANE)

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain; Urinary Retention; Post Operative Pain
• Intervention / Treatment: Procedure: Femoral Nerve Block; Procedure: Epidural

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Karachi, Pakistan
    • Aga Khan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group F; Femoral nerve Block Group	Procedure: Femoral Nerve Block; 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
Active Comparator: Group E; Epidural Group	Procedure: Epidural; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aga Khan University
• Investigators: Principal Investigator: Ausaf A Khan, Aga Khan University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: February 7, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Estimate): February 26, 2016
• Last Update Submitted That Met QC Criteria: February 25, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Epidural Analgesia; Femoral Nerve Block; Urinary Retention; Lumbar Epidural
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Urination Disorders; Pain, Postoperative; Acute Pain; Urinary Retention
• Other Study ID Numbers: CTU / UriKANE / 2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES