NCT02513979

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Aug 2015

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 8, 2015

Status Verified

July 1, 2015

Enrollment Period

2.2 years

First QC Date

July 28, 2015

Last Update Submit

October 7, 2015

Conditions

Hypertension

Keywords

Angiotensin type II receptor (AT2R) antagonistsAcute postoperative painChronic postoperative painAbdominal surgery

Outcome Measures

Primary Outcomes (1)

  • Acute pain after cough

    Intensity of pain after cough measured with the Visual Analogue Scale (VAS 0-100 mm)

    24 hours postoperatively

Secondary Outcomes (5)

  • 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

Other Outcomes (1)

  • Patient satisfaction

    24 hours postoperatively

Study Arms (2)

angiotensin type II receptor antagonists

ACTIVE COMPARATOR

Hypertensive patients treated with angiotensin type II receptor antagonists

Drug: Angiotensin type II receptor antagonists

No treatment

NO INTERVENTION

Normotensive patients

Interventions

Angiotensin type II receptor antagonistsDRUG

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

Also known as: AT2R antagonists
angiotensin type II receptor antagonists

Eligibility Criteria

Age35 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged between 35 and 79 years
  • ASA II or III
  • BMI ≤ 35

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Argyro Fassoulaki

Athens, 11528, Greece

RECRUITING

MeSH Terms

Conditions

HypertensionPain, Postoperative

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Argyro Fassoulaki, MD

    Aretaieio University Hospital

    PRINCIPAL INVESTIGATOR

  • Marianna Zotou, MD

    St Savas Hospital

    STUDY DIRECTOR

Central Study Contacts

Argyro Fassoulaki, MD, PhD

CONTACT

+30210 9024530afassou1@otenet.gr

Maria Valta, MD

CONTACT

+30210 8062133mariavalta@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emeritus

Study Record Dates

First Submitted

July 28, 2015

First Posted

August 3, 2015

Study Start

August 1, 2015

Primary Completion

October 1, 2017

Study Completion

January 1, 2018

Last Updated

October 8, 2015

Record last verified: 2015-07

Locations

GR(1)