The Effect of Angiotensin II Receptor Antagonists on Acute and Chronic Postoperative Pain in Patients Treated for Hypertension.
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Acute pain after cough
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged between 35 and 79 years
- •ASA II or III
- •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
Arms & Interventions
angiotensin type II receptor antagonists
Hypertensive patients treated with angiotensin type II receptor antagonists
Intervention: Angiotensin type II receptor antagonists (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Acute pain at rest(2, 4, 8 and 24 hours postoperatively)
- Acute pain after cough(2, 4 and 8 hours postoperatively)
- Analgesic consumption(2, 4, 8 and 24 hours postoperatively)
- Chronic pain(Three months postoperatively)
- Analgesic consumption for chronic pain(Three months postoperatively)
Investigators
Argyro Fassoulaki
Professor Emeritus
University of Athens