Postoperative Pain and Angiotensin II Receptor Antagonists (PP&ARA)
Primary Purpose
Hypertension
Status
Unknown status
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Angiotensin type II receptor antagonists
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Angiotensin type II receptor (AT2R) antagonists, Acute postoperative pain, Chronic postoperative pain, Abdominal surgery
Eligibility Criteria
Inclusion Criteria:
- Patients aged between 35 and 79 years
- ASA II or III
- BMI ≤ 35
- Elective abdominal surgery Exclusion Criteria:-
- Patients on analgesic, antidepressive, or sedative consumption during the last month
- Mental impairment
- Not speaking fluently Greek language
- Refuse to give written informed consent
- Diabetics
- Patients receiving antihypertensive treatment other than angiotensin type II receptor (AT2R) antagonists
Sites / Locations
- Argyro FassoulakiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
angiotensin type II receptor antagonists
No treatment
Arm Description
Hypertensive patients treated with angiotensin type II receptor antagonists
Normotensive patients
Outcomes
Primary Outcome Measures
Acute pain after cough
Intensity of pain after cough measured with the Visual Analogue Scale (VAS 0-100 mm)
Secondary Outcome Measures
Acute pain at rest
Intensity of pain at rest measured with the Visual Analogue Scale (VAS 0-100 mm)
Acute pain after cough
Intensity of pain after cough measured with the Visual Analogue Scale (VAS 0-100 mm)
Analgesic consumption
All analgesics converted to morphine equivalent (mg)
Chronic pain
Present or absent, if present characteristics (pricking, burning, throbbing)
Analgesic consumption for chronic pain
Yes or not, number of pills
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02513979
Brief Title
Postoperative Pain and Angiotensin II Receptor Antagonists
Acronym
PP&ARA
Official Title
The Effect of Angiotensin II Receptor Antagonists on Acute and Chronic Postoperative Pain in Patients Treated for Hypertension.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
An angiotensin II type 2 receptor (AT2R) antagonist has been assessed for its efficacy in neuropathic pain with promising results. A considerable number of patients undergoing surgery under general anesthesia are hypertensive and receive drugs to control high blood pressure, including angiotensin II receptor antagonists. These drugs may attenuate the acute and/or chronic postoperative pain or decrease the analgesic requirements after surgery. The aim of the present study is to assess the early postoperative pain and analgesic requirements in patients treated with antagonists of the angiotensin II receptors for at least three months before surgery compared to normotensive patients.
Detailed Description
Patients ASA I-III, aged between 35 and 79 years old, with BMI ≤ 35, scheduled for abdominal surgery, thus gynecological, urological and general surgery procedures will be recruited for the study. All patients will be scheduled in the morning list, informed for the study and will be asked to give written informed consent.
Exclusion Criteria will be patients on analgesic, antidepressive, or sedative consumption during the previous one month, mental impairment, not speaking Greek or refusing to give written informed consent, diabetics, patients receiving antihypertensive treatment other than angiotensin type II receptor (AT2R) antagonists.
Two groups of patients will be stydied: Patients hypertensive (the hypertensive group) receiving treatment for blood pressure control with angiotensin II receptor antagonists for at least three months preoperatively and a normotensive group.
Measurements
Pain intensity (visual analogue scale: VAS) from 0 to 100 will be reported 2, 4, 8, and 24 hours postoperatively with 0 representing no pain and 100 excruciate worst pain. Pain will be recorded at rest and subsequently patients will be asked to cough for three times.
Analgesics consumed at the same time points will be recorded.
Patient satisfaction (VAS 0-100) 24 h postoperatively (with special reference to pain)
Three months postoperatively patients will be contacted by phone and will be asked if they experience pain related to surgery or not. If yes pain characteristics, thus burning, pricking etc. will be recorded.
Three months postoperatively patients will be asked whether they used analgesics after discharge from the hospital for the postoperative pain.
Statistics Primary outcome of the study: Pain intensity 24 hours postoperatively after cough in patients receiving angiotensin II receptor antagonists, or no antihypertensive therapy. Secondary outcomes of the study are pain intensity 2, 4, 8 and 24 hours postoperatively at rest, 2, 4 and 8 hours after cough, analgesic consumption , 2, 4, 8 and 24 hours postoperatively, patient satisfaction regarding pain, presence of pain three months after surgery and if present its characteristics. Also, analgesic consumption during the first three months postoperatively due to surgery.
Statistics Power analysis: A 30% difference in pain intensity after cough 24 hours postoperatively between the angiotensin II receptor antagonists treated group compared and the treated group.
Acute pain at rest and after cough all the time points as defined by the study design will be compared between patients receiving antihypertensive treatment (angiotensin II receptors antagonists) and the controls.
Cumulative analgesics consumed 2, 4, 8 and 24 hours after surgery will be compared between the two groups.
The presence of chronic postsurgical pain and the need or not of analgesic intake due to chronic pain three months after surgery will be also compared between the hypertensive treated and normotensive patients.
Parametric or non-parametric tests will be used for normal and no normal distributions respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Angiotensin type II receptor (AT2R) antagonists, Acute postoperative pain, Chronic postoperative pain, Abdominal surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
angiotensin type II receptor antagonists
Arm Type
Active Comparator
Arm Description
Hypertensive patients treated with angiotensin type II receptor antagonists
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Normotensive patients
Intervention Type
Drug
Intervention Name(s)
Angiotensin type II receptor antagonists
Other Intervention Name(s)
AT2R antagonists
Intervention Description
Angiotensin type II receptor antagonists given to hypertensive patients treated with high blood pressure
Primary Outcome Measure Information:
Title
Acute pain after cough
Description
Intensity of pain after cough measured with the Visual Analogue Scale (VAS 0-100 mm)
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Acute pain at rest
Description
Intensity of pain at rest measured with the Visual Analogue Scale (VAS 0-100 mm)
Time Frame
2, 4, 8 and 24 hours postoperatively
Title
Acute pain after cough
Description
Intensity of pain after cough measured with the Visual Analogue Scale (VAS 0-100 mm)
Time Frame
2, 4 and 8 hours postoperatively
Title
Analgesic consumption
Description
All analgesics converted to morphine equivalent (mg)
Time Frame
2, 4, 8 and 24 hours postoperatively
Title
Chronic pain
Description
Present or absent, if present characteristics (pricking, burning, throbbing)
Time Frame
Three months postoperatively
Title
Analgesic consumption for chronic pain
Description
Yes or not, number of pills
Time Frame
Three months postoperatively
Other Pre-specified Outcome Measures:
Title
Patient satisfaction
Description
Patient satisfaction measured in a 0-100 mm scale with special reference to postoperative pain management
Time Frame
24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged between 35 and 79 years
ASA II or III
BMI ≤ 35
Elective abdominal surgery Exclusion Criteria:-
Patients on analgesic, antidepressive, or sedative consumption during the last month
Mental impairment
Not speaking fluently Greek language
Refuse to give written informed consent
Diabetics
Patients receiving antihypertensive treatment other than angiotensin type II receptor (AT2R) antagonists
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Argyro Fassoulaki, MD, PhD
Phone
+30210 9024530
Email
afassou1@otenet.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Valta, MD
Phone
+30210 8062133
Email
mariavalta@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Argyro Fassoulaki, MD
Organizational Affiliation
Aretaieio University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marianna Zotou, MD
Organizational Affiliation
St Savas Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Argyro Fassoulaki
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Argyro Fassoulaki, MD, PhD
Phone
+30 6936701333
Email
fassoula@aretaieio.uoa.gr
First Name & Middle Initial & Last Name & Degree
Maria Valta, MD
Phone
+30 6971554146
Email
mariavalta@yahoo.com
12. IPD Sharing Statement
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Postoperative Pain and Angiotensin II Receptor Antagonists
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