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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
Sponsor:
Information provided by (Responsible Party):
Argyro Fassoulaki, University of Athens

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Angiotensin type II receptor antagonists Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Normotensive patients



Primary Outcome Measures :
  1. Acute pain after cough [ Time Frame: 24 hours postoperatively ]
    Intensity of pain after cough measured with the Visual Analogue Scale (VAS 0-100 mm)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. Analgesic consumption [ Time Frame: 2, 4, 8 and 24 hours postoperatively ]
    All analgesics converted to morphine equivalent (mg)

  4. Chronic pain [ Time Frame: Three months postoperatively ]
    Present or absent, if present characteristics (pricking, burning, throbbing)

  5. Analgesic consumption for chronic pain [ Time Frame: Three months postoperatively ]
    Yes or not, number of pills


Other Outcome Measures:
  1. Patient satisfaction [ Time Frame: 24 hours postoperatively ]
    Patient satisfaction measured in a 0-100 mm scale with special reference to postoperative pain management



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Argyro Fassoulaki, MD, PhD +30210 9024530 afassou1@otenet.gr
Contact: Maria Valta, MD +30210 8062133 mariavalta@yahoo.com

Locations
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Greece
Argyro Fassoulaki Recruiting
Athens, Greece, 11528
Contact: Argyro Fassoulaki, MD, PhD    +30 6936701333    fassoula@aretaieio.uoa.gr   
Contact: Maria Valta, MD    +30 6971554146    mariavalta@yahoo.com   
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: Argyro Fassoulaki, MD Aretaieio University Hospital
Study Director: Marianna Zotou, MD St Savas Hospital

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Responsible Party: Argyro Fassoulaki, Professor Emeritus, University of Athens
ClinicalTrials.gov Identifier: NCT02513979    
Other Study ID Numbers: AHSTSA-102
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: July 2015
Keywords provided by Argyro Fassoulaki, University of Athens:
Angiotensin type II receptor (AT2R) antagonists
Acute postoperative pain
Chronic postoperative pain
Abdominal surgery
Additional relevant MeSH terms:
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Hypertension
Pain, Postoperative
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Angiotensin II
Giapreza
Angiotensinogen
Angiotensin Receptor Antagonists
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action