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Postoperative Urinary Retention in Orthopedic Patients

Primary Purpose

Urinary Retention, Anesthesia, Spinal, Orthopedic Procedures

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
spinal anesthesia with morphine
spinal anesthesia without morphine + peripheral nerve block
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Retention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    spinal anesthesia with morphine

    spinal anesthesia without morphine + peripheral nerve block

    Arm Description

    This patients received subarachnoid anesthesia with 20 mg of Hyperbaric Bupivacaine + 200 mcg of Morphine

    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.

    Outcomes

    Primary Outcome Measures

    Postoperative urinary retention
    Need for bladder catheterization in the first 24 hours after surgical procedure
    Postoperative urinary retention
    Time required for first spontaneous urination in the first 24 hours after surgical procedure

    Secondary Outcome Measures

    Nausea and vomiting
    Assess the incidence of nausea and vomiting in the groups studied
    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)
    Opioid consumption
    Assess morphine and codeine consumption. Dose used in the first 24 hours after surgical procedure

    Full Information

    First Posted
    February 14, 2020
    Last Updated
    March 4, 2020
    Sponsor
    Hospital de Clinicas de Porto Alegre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04298775
    Brief Title
    Postoperative Urinary Retention in Orthopedic Patients
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    July 13, 2019 (Actual)
    Study Completion Date
    July 13, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital de Clinicas de Porto Alegre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Retention, Anesthesia, Spinal, Orthopedic Procedures, Nerve Block

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    spinal anesthesia with morphine
    Arm Type
    Active Comparator
    Arm Description
    This patients received subarachnoid anesthesia with 20 mg of Hyperbaric Bupivacaine + 200 mcg of Morphine
    Arm Title
    spinal anesthesia without morphine + peripheral nerve block
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    spinal anesthesia with morphine
    Intervention Type
    Procedure
    Intervention Name(s)
    spinal anesthesia without morphine + peripheral nerve block
    Primary Outcome Measure Information:
    Title
    Postoperative urinary retention
    Description
    Need for bladder catheterization in the first 24 hours after surgical procedure
    Time Frame
    In 24 hours after surgical procedure
    Title
    Postoperative urinary retention
    Description
    Time required for first spontaneous urination in the first 24 hours after surgical procedure
    Time Frame
    In 24 hours after surgical procedure
    Secondary Outcome Measure Information:
    Title
    Nausea and vomiting
    Description
    Assess the incidence of nausea and vomiting in the groups studied
    Time Frame
    In 24 hours after surgical procedure
    Title
    Postoperative pain: Visual Analog Scale (VAS)
    Description
    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)
    Time Frame
    In 12 and 24 hours after surgical procedure
    Title
    Opioid consumption
    Description
    Assess morphine and codeine consumption. Dose used in the first 24 hours after surgical procedure
    Time Frame
    In the first 24 hours after surgical procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carolina L Schiavo, M.D, M.Sc
    Organizational Affiliation
    Hospital de Clinicas de Porto Alegre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Postoperative Urinary Retention in Orthopedic Patients

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