Acute PainUriKANENCT02689011
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)
A study testing Femoral Nerve Block and Epidural in people with Acute Pain and Urinary Retention, run by Aga Khan University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Acute Pain, Urinary Retention, Post Operative Pain
- What is being tested?
- Femoral Nerve Block and Epidural
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Physical status I, II \& III
- Male and Female Patients age between between 30 and 70 years
- Unilateral Total Knee Arthroplasty
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Femoral Nerve Block, Epidural
- Keywords
- Total Knee Arthroplasty, Femoral Nerve Block, Epidural Analgesia, Urinary Retention, Lumbar Epidural
- Medical subject headings
- Acute Pain, Urinary Retention, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Nerve BlockProcedure or surgery
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
EpiduralProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group F | Experimental | Femoral nerve Block Group Receives: Procedure: Femoral Nerve Block |
| Group E | Active comparator | Epidural Group Receives: Procedure: Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Hours
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: up to 48 hours
Surgical outcomes - food intake
To compare surgical outcomes like time of first food intake between the two groups
Measured: up to 48 hours
Patient satisfaction
To compare Patient satisfaction with the analgesic modality between the two groups
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ausaf Ahmed Khan, Aga Khan University
- Investigators
- Ausaf A Khan, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689011
- Sponsor's protocol ID
- CTU / UriKANE / 2013
- Acronym
- UriKANE
- Status last verified
- Feb 2016
- First submitted
- 7 Feb 2016
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02689011
- Acronym / sponsor ID
- UriKANE / CTU / UriKANE / 2013
- Conditions
- Acute Pain, Urinary Retention, Post Operative Pain
- Keywords
- Total Knee Arthroplasty, Femoral Nerve Block, Epidural Analgesia, Urinary Retention, Lumbar Epidural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group F | Experimental | Procedure: Femoral Nerve BlockFemoral nerve Block Group |
| Group E | Active comparator | Procedure: EpiduralEpidural Group |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA Physical status I, II \& III
- Male and Female Patients age between between 30 and 70 years
- Unilateral Total Knee Arthroplasty
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femoral Nerve BlockFor patients in Femoral nerve Block Group (Group F), ultrasound guided Femoral nerve block was performed using 0.375% bupivacaine, 20 ml for femoral nerve | Procedure or surgery | Group F |
| EpiduralPatients 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. | Procedure or surgery | Group E |
Primary outcome
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.
8 secondary outcomes
Mean post-operative nausea and vomiting scores
Time frame: up to 48 hours
Mean post-operative sedation scores
Time frame: up to 48 hours
Mean post-operative pain scores
Time frame: up to 48 hours
Surgical outcomes - maximal knee flexion
Time frame: up to 48 hours
Surgical outcomes - duration of post-operative hospital stay
Time frame: up to 48 hours
Surgical outcomes - mobilization out of bed
Time frame: up to 48 hours
Surgical outcomes - food intake
Time frame: up to 48 hours
Patient satisfaction
Time frame: 7 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ausaf A Khan principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral Nerve Block and Epidural in people with Acute Pain and Urinary Retention, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of urinary retention (time frame: 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.