Urinary RetentionNCT04298775
Postoperative Urinary Retention in Orthopedic Patients
A study testing spinal anesthesia with morphine and spinal anesthesia without morphine + peripheral nerve block in people with Urinary Retention and Anesthesia, Spinal, run by Hospital de Clinicas de Porto Alegre.
Trial summary
The objective of this study is to compare the incidence of postoperative urinary retention related to spinal anesthesia with morphine and spinal anesthesia associated with peripheral blockade in orthopedic procedures of lower limbs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention, Anesthesia, Spinal, Orthopedic Procedures
- What is being tested?
- spinal anesthesia with morphine and spinal anesthesia without morphine + peripheral nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 13 Jul 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing elective orthopedic surgeries of the lower limbs
- Possibility and acceptance of performing the surgical procedure under spinal anesthesia
- Minimum hospital stay of 24 hours
- Acceptance and signature of the informed consent form
Who cannot join
- Subjects who did not understand the Portuguese language
- Patients who did not agree with the informed consent term and / or did not sign
- Patients with a history of urological problems
- Severe cognitive disorders
- Patients who were unable to urinate spontaneously before surgery
About this study
Official title: Postoperative Urinary Retention in Orthopedic Patients Submitted to Intrathecal Anesthesia With Morphine Versus Intrathecal Anesthesia Without Opioid Associated With Peripheral Nerve Block: a Randomized Clinical Trial
The objective of this study is to compare the incidence of postoperative urinary retention related to spinal anesthesia with morphine and spinal anesthesia associated with peripheral blockade in orthopedic procedures of lower limbs. Secondary objectives are assessing the incidence of nausea and vomiting; postoperative pain and opioid consumption at 24 hours after surgery with each of the techniques. A total of 52 patients submitted to a lower limb orthopedic procedure were randomized to the intervention groups: spinal anesthesia with morphine versus spinal anesthesia without opioid associated with peripheral nerve block. After surgery, bladder ultrasound will be performed in post-anesthesia care unit to identify urinary retention and patients will be followed for 24 hours to assess outcomes.
Read the detailed description
This is a randomized clinical trial with simple blinding (the outcome evaluator is blind). Approved by the Ethics and Research Committee of Hospital de Clínicas de Porto Alegre under number 20160043 and Plataforma Brasil CAAE 57623815.1.0000.5327.To calculate the sample size, the program WinPEPI, version 11.43, was used. Considering 80% power, 5% significance level and data reported by Tomaszewski, Balkota and Machowicz (RUPO incidence of 42.86% of the spinal anesthesia group with morphine requiring urinary catheterization and 6.25% in patients undergoing peripheral nerve block ). The sample size found was 26 subjects in each group.
Statistical analysis was performed using SPSS STATISTICS software version 23. Absolute and percentage frequencies were calculated for qualitative variables. And mean, standard deviation and interquartile range for quantitative variables. The normality of the quantitative variables was assessed by the Shapiro-Wilk test. The chi-square test was used to assess the difference in the incidence of catheterization in the two groups and the incidence of nausea and vomiting in 24 hours. To evaluate the difference in the mean time to urination, even after sounding, the Student's t test for independent samples was used. Doses of codeine and morphine at 24 hours and assessment of pain on movement and rest at 12 and 24 hours (by the visual analog scale of pain) were assessed by the Mann Whitney test.
P <0.05 was considered statistically significant. The 52 patients included in the survey were allocated randomly to one of the study groups. Randomization was performed immediately before the interventions studied using the electronic random allocation application Randomizer for Clinical Trial for iPad / iPhone, developed by the company Medsharing (http://www.ecrfmedsharing.com/iphone_ipad_randomization.php).
All patients received spinal anesthesia. The technique included sterile preparation of the puncture site at the L3-L4 or L4-L5 level using Whitacre 27G or 25G needles. Group 1 patients received subarachnoid block with 20 mg of hyperbaric bupivacaine + 200 mcg of morphine and group 2 patients received subarachnoid block with 20 mg of hyperbaric bupivacaine and peripheral nerve block.Peripheral nerve blocks were performed after spinal anesthesia, before the start of the surgical procedure under ultrasound visualization associated with the use of neurostimulator. The choice of the nerve to be blocked was based on the innervation related to analgesia of the surgical site: femoral nerve block or sciatic nerve.
In the post-anesthetic care unit, the following parameters were assessed:
- Need for bladder catheterization;
- Time for spontaneous urination (time in minutes between subarachnoid block and spontaneous urination);
- Presence of pain and the need to use opioids;
- Presence of nausea / vomiting and the need to use antiemetics.
Patients were evaluated at 12 and 24 hours after the surgical procedure for:
- Need for bladder catheterization;
- Time for the first spontaneous urination (with or without previous relief bladder catheter);
- Presence of nausea / vomiting;
- Pain assessment by analogue-visual scale from 0 to 10, at the operated site, at rest and during movement;
- Need to use opioids, noting which opioid and dose used.
The postoperative prescription was standardized:
- Paracetamol 500 mg orally 6/6 hours fixed;
- Dipyrone 1 g intravenous 6/6 hours fixed;
- Codeine 30 mg orally 6/6 hours, if mild to moderate pain using an analogue-visual scale (1 to 6);
- Morphine 3 mg intravenously up to 3/3 hours, if severe pain by analogue-visual scale (7 to 10);
- Ondasentron 4 mg intravenously up to 8/8 hours, if nausea / vomiting is present.
- Being tested
- spinal anesthesia with morphine, spinal anesthesia without morphine + peripheral nerve block
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesia with morphineProcedure or surgery
spinal anesthesia without morphine + peripheral nerve blockProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| spinal anesthesia with morphine | Active comparator | This patients received subarachnoid anesthesia with 20 mg of Hyperbaric Bupivacaine + 200 mcg of Morphine Receives: Procedure: spinal anesthesia with morphine |
| spinal anesthesia without morphine + peripheral nerve block | Active comparator | This patients received subarachnoid anesthesia with 20 mg of Hyperbaric Bupivacaine and peripheral nerve block with 0.2 to 0.375% Ropivacaine, in a volume of 20 to 30 mL. Receives: Procedure: spinal anesthesia without morphine + peripheral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative urinary retention
Need for bladder catheterization in the first 24 hours after surgical procedure
Measured: In 24 hours after surgical procedure
Postoperative urinary retention
Time required for first spontaneous urination in the first 24 hours after surgical procedure
Measured: In 24 hours after surgical procedure
Secondary outcomes (3)
Nausea and vomiting
Assess the incidence of nausea and vomiting in the groups studied
Measured: In 24 hours after surgical procedure
Postoperative pain: Visual Analog Scale (VAS)
Evaluate postoperative pain 12 and 24 hours after the surgical procedure, at rest and on movement. Postoperative pain assessment will be performed using the Visual Analog Scale: Scale from Zero to 10 ( being Zero: without pain and 10: worst pain ever felt)
Measured: In 12 and 24 hours after surgical procedure
Opioid consumption
Assess morphine and codeine consumption. Dose used in the first 24 hours after surgical procedure
Measured: In the first 24 hours after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 Jan 2017
- Primary completion13 Jul 2019
- Study completion13 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolina L Schiavo, M.D, M.Sc, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298775
- Sponsor's protocol ID
- 20160443
- Status last verified
- Mar 2020
- First submitted
- 14 Feb 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Urinary Retention in Orthopedic Patients Submitted to Intrathecal Anesthesia With Morphine Versus Intrathecal Anesthesia Without Opioid Associated With Peripheral Nerve Block: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04298775
- Acronym / sponsor ID
- 20160443
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 13 Jul 2019 (actual)
- Study completion
- 13 Jul 2019 (actual)
- First posted
- 6 Mar 2020 (actual)
- 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.
The objective of this study is to compare the incidence of postoperative urinary retention related to spinal anesthesia with morphine and spinal anesthesia associated with peripheral blockade in orthopedic procedures of lower limbs. Secondary objectives are assessing the incidence of nausea and vomiting; postoperative pain and opioid consumption at 24 hours after surgery with each of the techniques. A total of 52 patients submitted to a lower limb orthopedic procedure were randomized to the intervention groups: spinal anesthesia with morphine versus spinal anesthesia without opioid associated with peripheral nerve block. After surgery, bladder ultrasound will be performed in post-anesthesia care unit to identify urinary retention and patients will be followed for 24 hours to assess outcomes.
Detailed description
This is a randomized clinical trial with simple blinding (the outcome evaluator is blind). Approved by the Ethics and Research Committee of Hospital de Clínicas de Porto Alegre under number 20160043 and Plataforma Brasil CAAE 57623815.1.0000.5327.To calculate the sample size, the program WinPEPI, version 11.43, was used. Considering 80% power, 5% significance level and data reported by Tomaszewski, Balkota and Machowicz (RUPO incidence of 42.86% of the spinal anesthesia group with morphine requiring urinary catheterization and 6.25% in patients undergoing peripheral nerve block ). The sample size found was 26 subjects in each group.
Statistical analysis was performed using SPSS STATISTICS software version 23. Absolute and percentage frequencies were calculated for qualitative variables. And mean, standard deviation and interquartile range for quantitative variables. The normality of the quantitative variables was assessed by the Shapiro-Wilk test. The chi-square test was used to assess the difference in the incidence of catheterization in the two groups and the incidence of nausea and vomiting in 24 hours. To evaluate the difference in the mean time to urination, even after sounding, the Student's t test for independent samples was used. Doses of codeine and morphine at 24 hours and assessment of pain on movement and rest at 12 and 24 hours (by the visual analog scale of pain) were assessed by the Mann Whitney test.
P <0.05 was considered statistically significant. The 52 patients included in the survey were allocated randomly to one of the study groups. Randomization was performed immediately before the interventions studied using the electronic random allocation application Randomizer for Clinical Trial for iPad / iPhone, developed by the company Medsharing (http://www.ecrfmedsharing.com/iphone_ipad_randomization.php).
All patients received spinal anesthesia. The technique included sterile preparation of the puncture site at the L3-L4 or L4-L5 level using Whitacre 27G or 25G needles. Group 1 patients received subarachnoid block with 20 mg of hyperbaric bupivacaine + 200 mcg of morphine and group 2 patients received subarachnoid block with 20 mg of hyperbaric bupivacaine and peripheral nerve block.Peripheral nerve blocks were performed after spinal anesthesia, before the start of the surgical procedure under ultrasound visualization associated with the use of neurostimulator. The choice of the nerve to be blocked was based on the innervation related to analgesia of the surgical site: femoral nerve block or sciatic nerve.
In the post-anesthetic care unit, the following parameters were assessed:
- Need for bladder catheterization;
- Time for spontaneous urination (time in minutes between subarachnoid block and spontaneous urination);
- Presence of pain and the need to use opioids;
- Presence of nausea / vomiting and the need to use antiemetics.
Patients were evaluated at 12 and 24 hours after the surgical procedure for:
- Need for bladder catheterization;
- Time for the first spontaneous urination (with or without previous relief bladder catheter);
- Presence of nausea / vomiting;
- Pain assessment by analogue-visual scale from 0 to 10, at the operated site, at rest and during movement;
- Need to use opioids, noting which opioid and dose used.
The postoperative prescription was standardized:
- Paracetamol 500 mg orally 6/6 hours fixed;
- Dipyrone 1 g intravenous 6/6 hours fixed;
- Codeine 30 mg orally 6/6 hours, if mild to moderate pain using an analogue-visual scale (1 to 6);
- Morphine 3 mg intravenously up to 3/3 hours, if severe pain by analogue-visual scale (7 to 10);
- Ondasentron 4 mg intravenously up to 8/8 hours, if nausea / vomiting is present.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal anesthesia with morphine | Active comparator | Procedure: spinal anesthesia with morphineThis patients received subarachnoid anesthesia with 20 mg of Hyperbaric Bupivacaine + 200 mcg of Morphine |
| spinal anesthesia without morphine + peripheral nerve block | Active comparator | Procedure: spinal anesthesia without morphine + peripheral nerve blockThis patients received subarachnoid anesthesia with 20 mg of Hyperbaric Bupivacaine and peripheral nerve block with 0.2 to 0.375% Ropivacaine, in a volume of 20 to 30 mL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing elective orthopedic surgeries of the lower limbs
- Possibility and acceptance of performing the surgical procedure under spinal anesthesia
- Minimum hospital stay of 24 hours
- Acceptance and signature of the informed consent form
Key exclusion criteria (5 listed)
- Subjects who did not understand the Portuguese language
- Patients who did not agree with the informed consent term and / or did not sign
- Patients with a history of urological problems
- Severe cognitive disorders
- Patients who were unable to urinate spontaneously before surgery
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 |
|---|---|---|
| spinal anesthesia with morphine | Procedure or surgery | spinal anesthesia with morphine |
| spinal anesthesia without morphine + peripheral nerve block | Procedure or surgery | spinal anesthesia without morphine + peripheral nerve block |
Primary outcome
Postoperative urinary retention
Time frame: In 24 hours after surgical procedure
Need for bladder catheterization in the first 24 hours after surgical procedure
Postoperative urinary retention
Time frame: In 24 hours after surgical procedure
Time required for first spontaneous urination in the first 24 hours after surgical procedure
3 secondary outcomes
Nausea and vomiting
Time frame: In 24 hours after surgical procedure
Postoperative pain: Visual Analog Scale (VAS)
Time frame: In 12 and 24 hours after surgical procedure
Opioid consumption
Time frame: In the first 24 hours after surgical procedure
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 6 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
Carolina L Schiavo, M.D, M.Sc principal investigator
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing spinal anesthesia with morphine and spinal anesthesia without morphine + peripheral nerve block in people with Urinary Retention and Anesthesia, Spinal, run by Hospital de Clinicas de Porto Alegre.
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 4 inclusion and 5 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 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Postoperative urinary retention (time frame: In 24 hours after surgical procedure). The study lists 2 primary outcomes in all. 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 6 Mar 2020.