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NCT Number: NCT02689011

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)

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.

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Key information

Conditions

Acute Pain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University

Karachi, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Incidence of urinary retention

    Time frame: 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 outcomes

  1. Mean post-operative nausea and vomiting scores

    Time frame: 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.

  2. Mean post-operative sedation scores

    Time frame: up to 48 hours

    To compare the mean post-operative sedation scores between the two groups at 0, 1, 12, 24 & 48 hours postoperatively.

  3. Mean post-operative pain scores

    Time frame: up to 48 hours

    To compare the mean post-operative pain scores between the two groups at 0, 1, 12, 24 & 48 hours postoperatively.

  4. Surgical outcomes - maximal knee flexion

    Time frame: up to 48 hours

    To compare surgical outcomes like maximal knee flexion at 24 & 48 hours between the two groups

  5. Surgical outcomes - duration of post-operative hospital stay

    Time frame: up to 48 hours

    To compare surgical outcomes like duration of post-operative hospital stay between the two groups

  6. Surgical outcomes - mobilization out of bed

    Time frame: up to 48 hours

    To compare surgical outcomes like time taken to mobilize out of bed between the two groups

  7. Surgical outcomes - food intake

    Time frame: up to 48 hours

    To compare surgical outcomes like time of first food intake between the two groups

  8. Patient satisfaction

    Time frame: 7 Days

    To compare Patient satisfaction with the analgesic modality between the two groups

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Acronym: UriKANE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 23, 2016
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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