Postoperative Pain and Angiotensin II Receptor Antagonists

Hypertension Clinical Trial

— PP&ARA  

Official title:

The Effect of Angiotensin II Receptor Antagonists on Acute and Chronic Postoperative Pain in Patients Treated for Hypertension.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02513979
• Other study ID #: AHSTSA-102
• Status: Recruiting
• Phase: Phase 4
• First received: July 28, 2015
• Last updated: October 7, 2015
• Start date: August 2015
• Est. completion date: January 2018

Study information

• Verified date: July 2015
• Source: University of Athens
• Contact: Argyro Fassoulaki, MD, PhD
• Phone: +30210 9024530
• Email: afassou1[@]otenet.gr
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 79 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Pain, Postoperative

Intervention

Drug:
• Angiotensin type II receptor antagonists
Angiotensin type II receptor antagonists given to hypertensive patients treated with high blood pressure

Locations

Country	Name	City	State
Greece	Argyro Fassoulaki	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction	Patient satisfaction measured in a 0-100 mm scale with special reference to postoperative pain management	24 hours postoperatively	Yes
Primary	Acute pain after cough	Intensity of pain after cough measured with the Visual Analogue Scale (VAS 0-100 mm)	24 hours postoperatively	Yes
Secondary	Acute pain at rest	Intensity of pain at rest measured with the Visual Analogue Scale (VAS 0-100 mm)	2, 4, 8 and 24 hours postoperatively	Yes
Secondary	Acute pain after cough	Intensity of pain after cough measured with the Visual Analogue Scale (VAS 0-100 mm)	2, 4 and 8 hours postoperatively	Yes
Secondary	Analgesic consumption	All analgesics converted to morphine equivalent (mg)	2, 4, 8 and 24 hours postoperatively	Yes
Secondary	Chronic pain	Present or absent, if present characteristics (pricking, burning, throbbing)	Three months postoperatively	Yes
Secondary	Analgesic consumption for chronic pain	Yes or not, number of pills	Three months postoperatively	Yes