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Postoperative Analgesia Impact of Narcotic Free Anesthesia (PAINFree)

Primary Purpose

Pain, Postoperative, Breast Cancer, Postoperative Nausea and Vomiting

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

fentanyl

beta-blocker (esmolol, metropolol)

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring Narcotic, Opioid, betablocking drug, postoperative pain, postoperative nausea and vomiting, breast cancer, hyperalgesia, cancer recurrence, anesthesia, mastectomy, chronic postsurgical pain syndrome, acute postoperative pain, postmastectomy pain syndrome, pain, ambulatory surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier Universitaire de Sherbrooke

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

fentanyl

beta-blocker

Arm Description

Instead of narcotics (fentanyl), esmolol and lopressor are being used for hemodynamic control

Outcomes

Primary Outcome Measures

Postoperative consumption of narcotic in recovery room

Secondary Outcome Measures

Pain level in recovery room

Occurence of nausea and vomiting in the recovery room

Time spent in recovery room

Chronic post-surgical pain

Reccurence of breast cancer

Full Information

NCT ID

NCT01544959

First Posted

September 9, 2010

Last Updated

October 23, 2018

Sponsor

Université de Sherbrooke

1. Study Identification

Unique Protocol Identification Number

NCT01544959

Brief Title

Postoperative Analgesia Impact of Narcotic Free Anesthesia

Acronym

PAINFree

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Université de Sherbrooke

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Breast Cancer, Postoperative Nausea and Vomiting

Keywords

Narcotic, Opioid, betablocking drug, postoperative pain, postoperative nausea and vomiting, breast cancer, hyperalgesia, cancer recurrence, anesthesia, mastectomy, chronic postsurgical pain syndrome, acute postoperative pain, postmastectomy pain syndrome, pain, ambulatory surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

fentanyl

Arm Type

Active Comparator

Arm Title

beta-blocker

Arm Type

Experimental

Arm Description

Instead of narcotics (fentanyl), esmolol and lopressor are being used for hemodynamic control

Intervention Type

Drug

Intervention Name(s)

fentanyl

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

beta-blocker (esmolol, metropolol)

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative consumption of narcotic in recovery room

Time Frame

Immediately after surgery

Secondary Outcome Measure Information:

Title

Pain level in recovery room

Time Frame

immediately after surgery

Title

Occurence of nausea and vomiting in the recovery room

Time Frame

immediately after surgery

Title

Time spent in recovery room

Time Frame

immediately after surgery

Title

Chronic post-surgical pain

Time Frame

3 and 6 months

Title

Reccurence of breast cancer

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Etienne de Medicis, MD MSc

Organizational Affiliation

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Universitaire de Sherbrooke

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

12. IPD Sharing Statement

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Postoperative Analgesia Impact of Narcotic Free Anesthesia

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