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OpenTrials
Completed

NCT Number: NCT02026427

Urinary Retention in Orthopedic Patients

The participants were hospitalized in Orthopedic and Traumatology Departments in Military Institute of Medicine, Warsaw, Poland.

The inclusion criteria were (1) age to 40 year-old, (2) no history of urologic problems, and (3) surgery under spinal anesthesia. All the patients where (1) opioids were administered during the surgery, (2) general anesthesia was necessary, and (3) the urinary bladder catheterization was perform during the surgery were excluded from the study.

The participants were randomly divided into the study and control groups. No oral premedication was administered. All the patients were asked to empty their urinary bladders before arrival to the operating theatre. When the standard monitoring (continuous electrocardiogram, noninvasive blood pressure, pulse oximetry) was started, intravenous premedication with midazolam was administered and lumbar spinal anesthesia with hyperbaric 0.5% solution of bupivacaine hydrochloride was performed.

In the study group, but not in the the control one, the 40 mg of drotaverine hydrochloride was administered intramuscularly. The decresed intravascular volume was corrected with cristalloids. During the surgery the adequate, not deeper than II grade according to Ramsay scale, level of sedationt was obtained with midazolam and/or propofol. All the participants received a questionaire in which we asked the questions about (1) the duration of anesthesia, (2) the time of micturition, (3) the time when discomfort or pain appeared in the lower abdomen, (4) the incidence of the urinary bladder catheterization and time to catheterization. On the next day after the surgery the questionaires were collected. In cases, when the patient's dischaged from the hospital was planned during the weekend, he or she was asked to pass on the questionaire to the nurses.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Military Institute of Medicine

Warsaw, 04-141, Poland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age below 40 y.o.,
  • surgery under spinal anesthesia,
  • no previous history of urological problems.

Exclusion criteria

  • opioid administration during surgery,
  • need for urinary bladder catheterization during surgery,
  • conversion to general anesthesia.

Treatment and study plan

Primary outcomes

  1. time to micturition

    Time frame: first 24 hours after spinal anesthesia

    Time (in minutes) from the administration of spinal anesthesia to spontaneous micturition.

Secondary outcomes

  1. urinary bladder catheterization

    Time frame: first 24 hours after spinal anesthesia

    • the need of urinary bladder catheterization, and
    • time from administration of spinal anesthesia to catheterization

Sponsors and collaborators

Lead sponsor

Military Institute od Medicine National Research Institute

Other

Registry information

Official study title

The Incidence of Urinary Retention in Orthopedic Patients Under Spinal Anesthesia

Acronym: UriRet

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 3, 2014
Registry last updated
Aug 7, 2014

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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