HypertensionPhase 4PP&ARANCT02513979
Postoperative Pain and Angiotensin II Receptor Antagonists
A Phase 4 study testing Angiotensin type II receptor antagonists in people with Hypertension, run by University of Athens at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 79 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Angiotensin type II receptor antagonists
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- Aug 2015to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Not speaking fluently Greek language
- Refuse to give written informed consent
- Diabetics
- Patients receiving antihypertensive treatment other than angiotensin type II receptor (AT2R) antagonists
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Argyro Fassoulaki
Athens, 11528
Argyro Fassoulaki, MD, PhD, +30 6936701333, fassoula@aretaieio.uoa.gr
Maria Valta, MD, +30 6971554146, mariavalta@yahoo.com
About this study
Official title: The Effect of Angiotensin II Receptor Antagonists on Acute and Chronic Postoperative Pain in Patients Treated for Hypertension.
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Angiotensin type II receptor antagonists
- Keywords
- Angiotensin type II receptor (AT2R) antagonists, Acute postoperative pain, Chronic postoperative pain, Abdominal surgery
- Medical subject headings
- Hypertension, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin type II receptor antagonistsDrug
Also called AT2R antagonists
Angiotensin type II receptor antagonists given to hypertensive patients treated with high blood pressure
| Study group | Role | What they receive |
|---|---|---|
| angiotensin type II receptor antagonists | Active comparator | Hypertensive patients treated with angiotensin type II receptor antagonists Receives: Drug: Angiotensin type II receptor antagonists |
| No treatment | No intervention | Normotensive patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute pain after cough
Intensity of pain after cough measured with the Visual Analogue Scale (VAS 0-100 mm)
Measured: 24 hours postoperatively
Secondary outcomes (5)
Acute pain at rest
Intensity of pain at rest measured with the Visual Analogue Scale (VAS 0-100 mm)
Measured: 2, 4, 8 and 24 hours postoperatively
Acute pain after cough
Intensity of pain after cough measured with the Visual Analogue Scale (VAS 0-100 mm)
Measured: 2, 4 and 8 hours postoperatively
Analgesic consumption
All analgesics converted to morphine equivalent (mg)
Measured: 2, 4, 8 and 24 hours postoperatively
Chronic pain
Present or absent, if present characteristics (pricking, burning, throbbing)
Measured: Three months postoperatively
Analgesic consumption for chronic pain
Yes or not, number of pills
Measured: Three months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Argyro Fassoulaki, University of Athens
- Investigators
- Argyro Fassoulaki, MD, Principal investigator, Aretaieio University HospitalMarianna Zotou, MD, Study director, St Savas Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513979
- Sponsor's protocol ID
- AHSTSA-102
- Acronym
- PP&ARA
- Status last verified
- Jul 2015
- First submitted
- 28 Jul 2015
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Angiotensin II Receptor Antagonists on Acute and Chronic Postoperative Pain in Patients Treated for Hypertension.
- ClinicalTrials.gov ID
- NCT02513979
- Acronym / sponsor ID
- PP&ARA / AHSTSA-102
- Conditions
- Hypertension
- Keywords
- Angiotensin type II receptor (AT2R) antagonists, Acute postoperative pain, Chronic postoperative pain, Abdominal surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 3 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| angiotensin type II receptor antagonists | Active comparator | Drug: Angiotensin type II receptor antagonistsHypertensive patients treated with angiotensin type II receptor antagonists |
| No treatment | No intervention | –Normotensive patients |
Who may qualify
- Ages
- 35 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin type II receptor antagonistsAlso: AT2R antagonistsAngiotensin type II receptor antagonists given to hypertensive patients treated with high blood pressure | Drug | angiotensin type II receptor antagonists |
Primary outcome
Acute pain after cough
Time frame: 24 hours postoperatively
Intensity of pain after cough measured with the Visual Analogue Scale (VAS 0-100 mm)
5 secondary outcomes
Acute pain at rest
Time frame: 2, 4, 8 and 24 hours postoperatively
Acute pain after cough
Time frame: 2, 4 and 8 hours postoperatively
Analgesic consumption
Time frame: 2, 4, 8 and 24 hours postoperatively
Chronic pain
Time frame: Three months postoperatively
Analgesic consumption for chronic pain
Time frame: Three months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Argyro Fassoulaki, MD principal investigator
Aretaieio University Hospital
Marianna Zotou, MD study director
St Savas Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Angiotensin type II receptor antagonists in people with Hypertension, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Argyro Fassoulaki, MD, PhD (+30210 9024530, afassou1@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute pain after cough (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.