Urinary Retention in Orthopedic Patients

Completed

• Conditions: Spinal Anesthesia; Urinary Retention; Orthopedic Patients

• Registration Number: NCT02026427
• Lead Sponsor: Military Institute od Medicine National Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2013-12-31
• Study First Submitted QC: 2013-12-31
• Study First Posted: 2014-01-03
• Primary Completion: 2014-06
• Status Verified: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-08-06
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
time to micturition	first 24 hours after spinal anesthesia	Time (in minutes) from the administration of spinal anesthesia to spontaneous micturition.

Secondary Outcome Measures

Name	Time	Method
urinary bladder catheterization	first 24 hours after spinal anesthesia	1. the need of urinary bladder catheterization, and; 2. time from administration of spinal anesthesia to catheterization

Trial Locations

Locations (1)

Military Institute of Medicine; 🇵🇱 Warsaw, Poland