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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02026427
Other study ID # 06101968-1
Secondary ID
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


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
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