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)

Not Applicable

Completed

• Conditions: Post Operative Pain; Acute Pain; Urinary Retention
• Interventions: Procedure: Femoral Nerve Block; Procedure: Epidural

• Registration Number: NCT02689011
• Lead Sponsor: Aga Khan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-02
• Study First Submitted: 2016-02-07
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-23
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group F	Femoral Nerve Block	Femoral nerve Block Group
Group E	Epidural	Epidural Group

Primary Outcome Measures

Name	Time	Method
Incidence of urinary retention	24 Hours	To compare the incidence of urinary retention in patients undergoing unilateral Total Knee Arthroplasty receiving continuous epidural analgesia vs. single shot Femoral Nerve Block.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Pakistan