Postoperative Pain and Angiotensin II Receptor Antagonists (PP&ARA)
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|ClinicalTrials.gov Identifier: NCT02513979|
Recruitment Status : Unknown
Verified July 2015 by Argyro Fassoulaki, University of Athens.
Recruitment status was: Recruiting
First Posted : August 3, 2015
Last Update Posted : October 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Angiotensin type II receptor antagonists||Phase 4|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of Angiotensin II Receptor Antagonists on Acute and Chronic Postoperative Pain in Patients Treated for Hypertension.|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||January 2018|
Active Comparator: angiotensin type II receptor antagonists
Hypertensive patients treated with angiotensin type II receptor antagonists
Drug: Angiotensin type II receptor antagonists
Angiotensin type II receptor antagonists given to hypertensive patients treated with high blood pressure
Other Name: AT2R antagonists
No Intervention: No treatment
- Acute pain after cough [ Time Frame: 24 hours postoperatively ]Intensity of pain after cough measured with the Visual Analogue Scale (VAS 0-100 mm)
- Acute pain at rest [ Time Frame: 2, 4, 8 and 24 hours postoperatively ]Intensity of pain at rest measured with the Visual Analogue Scale (VAS 0-100 mm)
- Acute pain after cough [ Time Frame: 2, 4 and 8 hours postoperatively ]Intensity of pain after cough measured with the Visual Analogue Scale (VAS 0-100 mm)
- Analgesic consumption [ Time Frame: 2, 4, 8 and 24 hours postoperatively ]All analgesics converted to morphine equivalent (mg)
- Chronic pain [ Time Frame: Three months postoperatively ]Present or absent, if present characteristics (pricking, burning, throbbing)
- Analgesic consumption for chronic pain [ Time Frame: Three months postoperatively ]Yes or not, number of pills
- Patient satisfaction [ Time Frame: 24 hours postoperatively ]Patient satisfaction measured in a 0-100 mm scale with special reference to postoperative pain management
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513979
|Contact: Argyro Fassoulaki, MD, PhD||+30210 email@example.com|
|Contact: Maria Valta, MD||+30210 firstname.lastname@example.org|
|Principal Investigator:||Argyro Fassoulaki, MD||Aretaieio University Hospital|
|Study Director:||Marianna Zotou, MD||St Savas Hospital|