Skip to main content
OpenTrials
Completed

NCT Number: NCT01544959

Postoperative Analgesia Impact of Narcotic Free Anesthesia

The first hypothesis of the study is that substituting fentanyl by esmolol and metoprolol during general anesthesia for patients undergoing mastectomy will result in less pain and less narcotic consumption in the recovery room. The investigators will also verify the impact of that substitution on nausea and vomiting, on the time spent in the recovery room and on chronic postsurgical pain (3 and 6 months).

Finally, the investigators will see the impact on breast cancer recurrence 5 years after the surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Postoperative Breast Cancer Breast Diseases Breast Neoplasms Hyperalgesia Nausea Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Sensation Disorders Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin and Connective Tissue Diseases Somatosensory Disorders Vomiting

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Woman
  • 18 to 65 years old
  • ASA 1 or 2
  • First breast surgery
  • Unilateral breast cancer
  • Partial mastectomy or radical modified mastectomy ± axillary dissection

Exclusion criteria

  • Allergy or contrindication to any medication figuring in the protocol or to Aspirin
  • Patient taking betablocking drug drug or lanoxin or calcic channels blocking drug
  • Narcotic consumption in the past month of 10 mg/day of morphine equivalent
  • Chronic pain
  • Moderate to severe asthma
  • BMI of more than 40
  • Diabetes
  • Chronic renal or hepatic faiure
  • Heart failure
  • Anticipated difficult airway
  • High grade heart block or bifascicular block
  • Mental retardation

Treatment and study plan

Fentanyl

Drug

Use of esmolol and metoprolol compared to use of fentanyl for hemodynamic control during general anesthesia. At induction, fentanyl (2 mcg/kg) is replaced by esmolol (1 mg/kg). During the case, with a standardised anesthesia, response to surgical stimulation will be medicated either by fentanyl (50 mcg aliquot) or metropolol (2.5 mg), for a maximum of 6 doses. After this, fentanyl will be given unblindly.

beta-blocker (esmolol, metropolol)

Drug

esmolol is used at induction and lopressor during surgery instead of fentanyl in response to surgical stimulation.

Primary outcomes

  1. Postoperative consumption of narcotic in recovery room

    Time frame: Immediately after surgery

Secondary outcomes

  1. Pain level in recovery room

    Time frame: immediately after surgery

  2. Occurence of nausea and vomiting in the recovery room

    Time frame: immediately after surgery

  3. Time spent in recovery room

    Time frame: immediately after surgery

  4. Chronic post-surgical pain

    Time frame: 3 and 6 months

  5. Reccurence of breast cancer

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

The Impact on Postoperative Pain of Substituting Opioids by Beta Blockers for Peroperative Hemodynamic Control in Patients Undergoing Mastectomy

Acronym: PAINFree

Important dates

Study start
2010
Primary completion
2013
Study completion
2018
First posted
Mar 6, 2012
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.