Urinary Retention in Orthopedic Patients (UriRet)

The Incidence of Urinary Retention in Orthopedic Patients Under Spinal Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia; Urinary Retention; Orthopedic Patients

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 04-141
    • Military Institute of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients scheduled for orthopedic surgery under spinal anesthesia.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Drotaverine; 40 mg of drotaverine hydrochloride administered intramuscularly just after the proper level of spinal anesthesia was achieved.
Control; Without intramuscular administration of drotaverine hydrochloride.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to micturition	Time (in minutes) from the administration of spinal anesthesia to spontaneous micturition.	first 24 hours after spinal anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urinary bladder catheterization	the need of urinary bladder catheterization, and; time from administration of spinal anesthesia to catheterization	first 24 hours after spinal anesthesia

Collaborators and Investigators

• Sponsor: Military Institute of Medicine, Poland

Publications and helpful links

General Publications

• Tomaszewski D, Balkota M. Intramuscular Administration of Drotaverine Hydrochloride Decreases Both Incidence of Urinary Retention and Time to Micturition in Orthopedic Patients under Spinal Anesthesia: A Single Blinded Randomized Study. Biomed Res Int. 2015;2015:926953. doi: 10.1155/2015/926953. Epub 2015 Jun 21.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: December 31, 2013
• First Submitted That Met QC Criteria: December 31, 2013
• First Posted (Estimate): January 3, 2014

Study Record Updates

• Last Update Posted (Estimate): August 7, 2014
• Last Update Submitted That Met QC Criteria: August 6, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention
• Other Study ID Numbers: 06101968-1