Urinary Retention in Orthopedic Patients

Urinary Retention Clinical Trial

— UriRet  

Official title:

The Incidence of Urinary Retention in Orthopedic Patients Under Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026427
• Other study ID #: 06101968-1
• Status: Completed
• Phase: N/A
• First received: December 31, 2013
• Last updated: August 6, 2014
• Start date: August 2010
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Military Institute of Medicine, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Orthopedic Patients
• Spinal Anesthesia
• Urinary Retention

Locations

Country	Name	City	State
Poland	Military Institute of Medicine	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Military Institute of Medicine, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to micturition	Time (in minutes) from the administration of spinal anesthesia to spontaneous micturition.	first 24 hours after spinal anesthesia	No
Secondary	urinary bladder catheterization	the need of urinary bladder catheterization, and; time from administration of spinal anesthesia to catheterization	first 24 hours after spinal anesthesia	No