Urinary Retention in Orthopedic Patients

NCT02026427 | Completed

• 1 other identifier: 06101968-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention; Orthopedic Patients; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• time to micturition

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

  first 24 hours after spinal anesthesia

Secondary Outcomes (1)

• urinary bladder catheterization

  first 24 hours after spinal anesthesia

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for orthopedic surgery under spinal anesthesia.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Military Institute of Medicine

Warsaw, 04-141, Poland

Location

Related Publications (1)

• 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.

  PMID: 26185766 DERIVED

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 31, 2013
• First Posted: January 3, 2014
• Study Start: August 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 7, 2014

Record last verified: 2014-08

Locations

PL (1)