Pain, PostoperativePAINFreeNCT01544959
Postoperative Analgesia Impact of Narcotic Free Anesthesia
A study testing fentanyl and beta-blocker (esmolol, metropolol) in people with Pain, Postoperative and Breast Cancer, run by Université de Sherbrooke at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pain, Postoperative, Breast Cancer, Postoperative Nausea and Vomiting
- What is being tested?
- fentanyl and beta-blocker (esmolol, metropolol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman
- 18 to 65 years old
- ASA 1 or 2
- First breast surgery
- Unilateral breast cancer
- Partial mastectomy or radical modified mastectomy ± axillary dissection
Who cannot join
- 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
Show all 12Show fewer
- Diabetes
- Chronic renal or hepatic faiure
- Heart failure
- Anticipated difficult airway
- High grade heart block or bifascicular block
- Mental retardation
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: The Impact on Postoperative Pain of Substituting Opioids by Beta Blockers for Peroperative Hemodynamic Control in Patients Undergoing Mastectomy
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.
- Being tested
- fentanyl, beta-blocker (esmolol, metropolol)
- 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
- Medical subject headings
- Pain, Postoperative, Breast Neoplasms, Postoperative Nausea and Vomiting, Hyperalgesia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanylDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| fentanyl | Active comparator | Not described Receives: Drug: fentanyl |
| beta-blocker | Experimental | Instead of narcotics (fentanyl), esmolol and lopressor are being used for hemodynamic control Receives: Drug: beta-blocker (esmolol, metropolol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative consumption of narcotic in recovery room
Measured: Immediately after surgery
Secondary outcomes (5)
Pain level in recovery room
Measured: immediately after surgery
Occurence of nausea and vomiting in the recovery room
Measured: immediately after surgery
Time spent in recovery room
Measured: immediately after surgery
Chronic post-surgical pain
Measured: 3 and 6 months
Reccurence of breast cancer
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Etienne de Medicis, Université de Sherbrooke
- Investigators
- Etienne de Medicis, MD MSc, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544959
- Sponsor's protocol ID
- CRC-09-174
- Other IDs
- CAS-008-2010
- Acronym
- PAINFree
- Status last verified
- Oct 2018
- First submitted
- 9 Sep 2010
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact on Postoperative Pain of Substituting Opioids by Beta Blockers for Peroperative Hemodynamic Control in Patients Undergoing Mastectomy
- ClinicalTrials.gov ID
- NCT01544959
- Acronym / sponsor ID
- PAINFree / CRC-09-174
- Keywords
- Narcotic, Opioid, betablocking drug, postoperative pain, postoperative nausea and vomiting, breast cancer, hyperalgesia, cancer recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 6 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fentanyl | Active comparator | Drug: fentanyl |
| beta-blocker | Experimental | Drug: beta-blocker (esmolol, metropolol)Instead of narcotics (fentanyl), esmolol and lopressor are being used for hemodynamic control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Woman
- 18 to 65 years old
- ASA 1 or 2
- First breast surgery
- Unilateral breast cancer
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fentanylUse 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. | Drug | fentanyl |
| beta-blocker (esmolol, metropolol)esmolol is used at induction and lopressor during surgery instead of fentanyl in response to surgical stimulation. | Drug | beta-blocker |
Primary outcome
Postoperative consumption of narcotic in recovery room
Time frame: Immediately after surgery
5 secondary outcomes
Pain level in recovery room
Time frame: immediately after surgery
Occurence of nausea and vomiting in the recovery room
Time frame: immediately after surgery
Time spent in recovery room
Time frame: immediately after surgery
Chronic post-surgical pain
Time frame: 3 and 6 months
Reccurence of breast cancer
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne de Medicis, MD MSc principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fentanyl and beta-blocker (esmolol, metropolol) in people with Pain, Postoperative and Breast Cancer, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative consumption of narcotic in recovery room (time frame: Immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.