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)

Acute Pain Clinical Trial

— UriKANE  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689011
• Other study ID #: CTU / UriKANE / 2013
• Status: Completed
• Phase: N/A
• First received: February 7, 2016
• Last updated: February 25, 2016
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: February 2016
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Aga Khan University Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Pain
• Pain, Postoperative
• Post Operative Pain
• Urinary Retention

Intervention

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
• 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.

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Surgical outcomes - food intake	To compare surgical outcomes like time of first food intake between the two groups	up to 48 hours	No
Secondary	Patient satisfaction	To compare Patient satisfaction with the analgesic modality between the two groups	7 Days	No