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)

NCT02689011 | Completed DMC

• 1 other identifier: CTU / UriKANE / 2013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain; Urinary Retention; Post Operative Pain

Keywords

Total Knee Arthroplasty; Femoral Nerve Block; Epidural Analgesia; Urinary Retention; Lumbar Epidural

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Mean post-operative nausea and vomiting scores

  up to 48 hours

• Mean post-operative sedation scores

  up to 48 hours

• Mean post-operative pain scores

  up to 48 hours

• Surgical outcomes - maximal knee flexion

  up to 48 hours

• Surgical outcomes - duration of post-operative hospital stay

  up to 48 hours

Study Arms (2)

Group F

EXPERIMENTAL

Femoral nerve Block Group

Procedure: Femoral Nerve Block

Group E

ACTIVE COMPARATOR

Epidural Group

Procedure: Epidural

Interventions

Femoral Nerve Block PROCEDURE

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

Group F

Epidural PROCEDURE

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.

Group E

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA Physical status I, II \& III
• Male and Female Patients age between between 30 and 70 years
• Unilateral Total Knee Arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Pakistan

Location

MeSH Terms

Conditions

Acute Pain; Urinary Retention; Pain, Postoperative

Interventions

Injections, Epidural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ausaf A Khan

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: February 7, 2016
• First Posted: February 23, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 26, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)