Relationship of Essential Hypertension and Its Treatments on the Postoperative Pain Management: a Prospective, Observational, Cross-sectional Study

Hypertension Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02244177
• Other study ID #: VGHKS-103-080
• Status: Recruiting
• Phase: N/A
• First received: September 10, 2014
• Last updated: March 30, 2015
• Start date: November 2013

Study information

• Verified date: March 2015
• Source: Kaohsiung Veterans General Hospital.
• Contact: Yuan Yi Chia, Bachelor
• Phone: 88673468183
• Email: yychia[@]isca.vghks.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Numbers of postoperative PCA related side effects among three groups will be determined by comparing and analyzing frequency distributions. To determine whether the patients with hypertension require less post operative opiate analgesics than others, multivariate analysis with repeated measures will be performed to identify the major and the minor factors predicting the use of postoperative pain therapy. The major aim of the study is to test the hypothesis that the morphine comsumpted by the hypertension group is less than those of the normotension group. The minor aims for the study are the difference related to pain intensity, or the incidence of side effects among groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• 300 eligible subjects

• No contraindication for inhalation anesthesia

• Elective surgery

• Age between 20-75 y/o

• No contraindication for postoperative morphine pain control

• Female or male

• Essential hypertension stage I and II (140<=SBP<=180; 90<=DBP<=110)

Exclusion Criteria:

• Liver disease

• Renal disease

• Those who is presumed to go to ICU after surgery

• The patients with dementia or conscious disturbance

• Pregnancy or breast feeding

• Secondary hypertension

• events in recent 6 months myocardial infarction cardiac bypass surgery unstable angina cerebrovascular events congestive heart failure significant arrhythmia thoracic surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	side effects		Post-operation Day1 to Day4	Yes
Primary	Pain		Post-operation Day1 to Day4	Yes
Secondary	Morphine consumption		Post-operation Day1 to Day4	Yes