Postoperative Analgesia Impact of Narcotic Free Anesthesia

Breast Cancer Clinical Trial

— PAINFree  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544959
• Other study ID #: CRC-09-174
• Secondary ID: CAS-008-2010
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: May 2018

Study information

• Verified date: October 2018
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 2018
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Nausea
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative consumption of narcotic in recovery room		Immediately after surgery
Secondary	Pain level in recovery room		immediately after surgery
Secondary	Occurence of nausea and vomiting in the recovery room		immediately after surgery
Secondary	Time spent in recovery room		immediately after surgery
Secondary	Chronic post-surgical pain		3 and 6 months
Secondary	Reccurence of breast cancer		5 years