AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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 groups in NCT04298775
Study groupRoleWhat they receive
spinal anesthesia with morphineActive comparatorThis 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 blockActive comparatorThis 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.

  1. Postoperative urinary retention

    Need for bladder catheterization in the first 24 hours after surgical procedure

    Measured: In 24 hours after surgical procedure

  2. 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)
  1. Nausea and vomiting

    Assess the incidence of nausea and vomiting in the groups studied

    Measured: In 24 hours after surgical procedure

  2. 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

  3. 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.

  1. First posted6 Mar 2020
  2. Study start1 Jan 2017
  3. Primary completion13 Jul 2019
  4. Study completion13 Jul 2019

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in