Breast Neoplasm FemaleNCT03117894
PECS-2 for Breast Surgery
A study testing Ropivacaine 5 mg/ml, 35 ml, Remifentanil 50 microg/ml and Betamethason 4 mg in people with Breast Neoplasm Female and Regional Anesthesia, run by Umeå University at 1 site in Sweden.
Trial summary
There is no consensus regarding which alternative is the best anesthesia for breast surgery, general anesthesia and morphine for postoperative analgesia or a combination of regional anesthesia and general anesthesia that possibly attenuates or abolishes the need for morphine. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female, Regional Anesthesia, Anesthesia
- What is being tested?
- Ropivacaine 5 mg/ml, 35 ml, Remifentanil 50 microg/ml and Betamethason 4 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 23 May 2017to 22 Oct 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Bilateral surgery
- Metastases other than in the axilla
- Body Mass Index (BMI) > 35
- Not able to communicate in Swedish
- Dementia
- American Society of Anesthesiology (ASA) 4 or 5
Show all 12Show fewer
- Chronic pain treatment (use of opiates or medicine for neuropathic pain > 7 days the last month)
- Known allergy to Morphine or Ropivacaine
- Congestive Heart Failure, New York Heart Association (NYHA) IIIB or worse
- Chronic renal failure (S-creatinine increased)
- Immunosuppression (more than 10 mg daily of Prednisolone or stronger medication)
- No axillary exploration planned
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regional Anesthesia for Breast Cancer Surgery, Effects on Postoperative Wellbeing and Disease Recurrence.
There is no consensus regarding which alternative is the best anesthesia for breast surgery, general anesthesia and morphine for postoperative analgesia or a combination of regional anesthesia and general anesthesia that possibly attenuates or abolishes the need for morphine.
The current study aims to determine which of the two strategies that is best in relation to postoperative pain, nausea and risk of recurrence of the disease.
Read the detailed description
Surgery for suspected or confirmed breast cancer is a common procedure world wide. The Swedish National board of health- and welfare reports that > 7000 women is diagnosed with breast cancer each year in Sweden.
Surgery always comes at the cost of a painful stimuli. It is of great importance that the anesthetist has anticipated this pain and has a plan to handle it.
The most common way to do this is to anesthetise the patient (put him or her to sleep, also called a General Anesthesia (GA)) for the surgical procedure and administer a strong analgesic (usually morphine) before the patient is awaken. Morphine has side-effects.
Another possible plan is to rely on a Regional Anesthesia (RA) (block pain from a certain part of the body) to take care of the pain, both during and after the surgery. Thereby this patient may be awake during the surgery. The two strategies may also be combined. That is, a regional anesthesia is applied before surgery but the patient is also put to sleep. The regional anesthesia is then fully effective when the patient is awaken and no strong analgesics are administered. The approach with a regional anesthesia is common in orthopedic surgery, either in combination with or without a general anesthesia.
For surgery on the breast, there has been few alternatives available for regional anesthesia. They have been considered to invasive for regular use and not been incorporated in clinical praxis as a routine.
The praxis of regional anesthesia has expanded tremendously in recent years. This is attributed to the increased use of ultrasound as a guide for the injection of anesthetic compounds in proximity to the nerves. The pectoral nerve block (PECS) was first described in 2011. It has since then been developed further and is much more feasible than the older alternatives for regional anesthesia covering the breast.
Therefore it has gained some popularity and a few studies on its performance have been published in recent years. It is still not clear though, if it really confers the patient a better postoperative situation regarding pain and nausea.
Further, observational studies have suggested that malignant disease is spread and hence recurs less often if the surgery is performed in conjunction with a regional anesthesia. These results have not yet been confirmed in randomized trials. Therefore, the investigators will use the data from the current study and also look if there is a difference between the study groups regarding recurrence of the disease and mortality three and five years after inclusion in the study.
A subgroup analysis will be made on the patients that has a mastectomy.
- Conditions
- Breast Neoplasm Female, Regional Anesthesia, Anesthesia, Regional Anesthesia Morbidity, Anesthesia Morbidity
- Being tested
- Ropivacaine 5 mg/ml, 35 ml, Remifentanil 50 microg/ml, Betamethason 4 mg, Paracetamol 1,5 g, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 5 mg/ml, 35 mlDrug
Regional Anesthesia. The deposition of local anesthetics in proximity of nerves with the aim of blocking nerve transmission. This is used to block pain as an alternative to systemic treatment of pain.
Remifentanil 50 microg/mlDrug
The intravenous administration of anesthetics aiming to induce analgesia (part of the general anesthesia). No fixed dose, administered in relation to the study participants need at the moment.
Betamethason 4 mgDrug
Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered preoperatively.
Paracetamol 1,5 gDrug
Also called Prevention of pain
Administered preoperatively to prevent pain postoperatively.
PropofolDrug
The intravenous administration of anesthetics aiming to induce sleep (part of the general anesthesia). No fixed dose, administered in relation to the study participants need at the moment.
Arcoxia, 120 mgDrug
Administered preoperatively to prevent pain postoperatively.
Ondansetron 4 mgDrug
Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered peroperative.
MorphineDrug
Administered peroperative, at the end of the surgery, before awakening the study participant. The aim is to prevent pain.
| Study group | Role | What they receive |
|---|---|---|
| GA with RA | Active comparator | Regional Anesthesia and General Anesthesia. Receives: Drug: Ropivacaine 5 mg/ml, 35 ml; Drug: Remifentanil 50 microg/ml; Drug: Betamethason 4 mg; Drug: Paracetamol 1,5 g; Drug: Propofol; Drug: Arcoxia, 120 mg; Drug: Ondansetron 4 mg |
| GA without RA | Active comparator | Only General Anesthesia (without a supplemental Regional Anesthesia). Receives: Drug: Remifentanil 50 microg/ml; Drug: Betamethason 4 mg; Drug: Paracetamol 1,5 g; Drug: Propofol; Drug: Arcoxia, 120 mg; Drug: Ondansetron 4 mg; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiate consumption
The cumulative consumption of opiates (Morphine). This is the most often used way to asses the efficacy of the regional anesthesia that the intervention consists of.
Measured: 48 hours
All cause mortality
This is to investigate the possible effect that a regional anesthesia may have on recurrence of a malignant tumor.
Measured: 3 years and 5 years.
Secondary outcomes (4)
Postoperative Nausea and Vomiting (PONV)
PONV is common after general anesthesia and more so if opiates are used for analgesia. Measured on an ordinal scale 0=no PONV, 1=nausea, 2=vomiting, 3=repeated vomiting
Measured: 48 hours
Actual pain score
To see if patients with a regional anesthesia have more or less pain than patients with intravenous Morphine as postoperative analgesia.
Measured: 48 hours
Recurrence of breast neoplasm
Recurrence of breast neoplasm
Measured: 3 and 5 years
Chronic Pain
Pain after 6 months as assessed in a telephone interview, measured as Numeric Rate Scale (0-10).
Measured: 6 (5-7) months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start23 May 2017
- Primary completion22 Oct 2020
- Study completion22 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joakim Johansson, PhD, Principal investigator, Umea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117894
- Sponsor's protocol ID
- UmeaU-PECS
- Status last verified
- May 2021
- First submitted
- 6 Mar 2017
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahlberg H, Wallgren D, Hultin M, Myrberg T, Johansson J. Less use of rescue morphine when a combined PSP/IPP-block is used for postoperative analgesia in breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2023 Sep 1;40(9):636-642. doi: 10.1097/EJA.0000000000001795. Epub 2023 Jan 12.
PubMed 36633115
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Anesthesia for Breast Cancer Surgery, Effects on Postoperative Wellbeing and Disease Recurrence.
- ClinicalTrials.gov ID
- NCT03117894
- Acronym / sponsor ID
- UmeaU-PECS
- Conditions
- Breast Neoplasm Female, Regional Anesthesia, Anesthesia, Regional Anesthesia Morbidity, Anesthesia Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 22 Oct 2020 (actual)
- Study completion
- 22 Oct 2020 (actual)
- First posted
- 18 Apr 2017 (actual)
- 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.
There is no consensus regarding which alternative is the best anesthesia for breast surgery, general anesthesia and morphine for postoperative analgesia or a combination of regional anesthesia and general anesthesia that possibly attenuates or abolishes the need for morphine.
The current study aims to determine which of the two strategies that is best in relation to postoperative pain, nausea and risk of recurrence of the disease.
Detailed description
Surgery for suspected or confirmed breast cancer is a common procedure world wide. The Swedish National board of health- and welfare reports that > 7000 women is diagnosed with breast cancer each year in Sweden.
Surgery always comes at the cost of a painful stimuli. It is of great importance that the anesthetist has anticipated this pain and has a plan to handle it.
The most common way to do this is to anesthetise the patient (put him or her to sleep, also called a General Anesthesia (GA)) for the surgical procedure and administer a strong analgesic (usually morphine) before the patient is awaken. Morphine has side-effects.
Another possible plan is to rely on a Regional Anesthesia (RA) (block pain from a certain part of the body) to take care of the pain, both during and after the surgery. Thereby this patient may be awake during the surgery. The two strategies may also be combined. That is, a regional anesthesia is applied before surgery but the patient is also put to sleep. The regional anesthesia is then fully effective when the patient is awaken and no strong analgesics are administered. The approach with a regional anesthesia is common in orthopedic surgery, either in combination with or without a general anesthesia.
For surgery on the breast, there has been few alternatives available for regional anesthesia. They have been considered to invasive for regular use and not been incorporated in clinical praxis as a routine.
The praxis of regional anesthesia has expanded tremendously in recent years. This is attributed to the increased use of ultrasound as a guide for the injection of anesthetic compounds in proximity to the nerves. The pectoral nerve block (PECS) was first described in 2011. It has since then been developed further and is much more feasible than the older alternatives for regional anesthesia covering the breast.
Therefore it has gained some popularity and a few studies on its performance have been published in recent years. It is still not clear though, if it really confers the patient a better postoperative situation regarding pain and nausea.
Further, observational studies have suggested that malignant disease is spread and hence recurs less often if the surgery is performed in conjunction with a regional anesthesia. These results have not yet been confirmed in randomized trials. Therefore, the investigators will use the data from the current study and also look if there is a difference between the study groups regarding recurrence of the disease and mortality three and five years after inclusion in the study.
A subgroup analysis will be made on the patients that has a mastectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GA with RA | Active comparator | Drug: Ropivacaine 5 mg/ml, 35 ml, Drug: Remifentanil 50 microg/ml, Drug: Betamethason 4 mg, Drug: Paracetamol 1,5 g, Drug: Propofol, Drug: Arcoxia, 120 mg, Drug: Ondansetron 4 mgRegional Anesthesia and General Anesthesia. |
| GA without RA | Active comparator | Drug: Remifentanil 50 microg/ml, Drug: Betamethason 4 mg, Drug: Paracetamol 1,5 g, Drug: Propofol, Drug: Arcoxia, 120 mg, Drug: Ondansetron 4 mg, Drug: MorphineOnly General Anesthesia (without a supplemental Regional Anesthesia). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Bilateral surgery
- Metastases other than in the axilla
- Body Mass Index (BMI) > 35
- Not able to communicate in Swedish
- Dementia
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 |
|---|---|---|
| Ropivacaine 5 mg/ml, 35 mlRegional Anesthesia. The deposition of local anesthetics in proximity of nerves with the aim of blocking nerve transmission. This is used to block pain as an alternative to systemic treatment of pain. | Drug | GA with RA |
| Remifentanil 50 microg/mlThe intravenous administration of anesthetics aiming to induce analgesia (part of the general anesthesia). No fixed dose, administered in relation to the study participants need at the moment. | Drug | GA with RA, GA without RA |
| Betamethason 4 mgAre meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered preoperatively. | Drug | GA with RA, GA without RA |
| Paracetamol 1,5 gAlso: Prevention of painAdministered preoperatively to prevent pain postoperatively. | Drug | GA with RA, GA without RA |
| PropofolThe intravenous administration of anesthetics aiming to induce sleep (part of the general anesthesia). No fixed dose, administered in relation to the study participants need at the moment. | Drug | GA with RA, GA without RA |
| Arcoxia, 120 mgAdministered preoperatively to prevent pain postoperatively. | Drug | GA with RA, GA without RA |
| Ondansetron 4 mgAre meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered peroperative. | Drug | GA with RA, GA without RA |
| MorphineAdministered peroperative, at the end of the surgery, before awakening the study participant. The aim is to prevent pain. | Drug | GA without RA |
Primary outcome
Opiate consumption
Time frame: 48 hours
The cumulative consumption of opiates (Morphine). This is the most often used way to asses the efficacy of the regional anesthesia that the intervention consists of.
All cause mortality
Time frame: 3 years and 5 years.
This is to investigate the possible effect that a regional anesthesia may have on recurrence of a malignant tumor.
4 secondary outcomes
Postoperative Nausea and Vomiting (PONV)
Time frame: 48 hours
Actual pain score
Time frame: 48 hours
Recurrence of breast neoplasm
Time frame: 3 and 5 years
Chronic Pain
Time frame: 6 (5-7) months after surgery
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 4 Jun 2021.
- Derived from this study: PubMed 36633115Ahlberg H, Wallgren D, Hultin M, Myrberg T, Johansson J. Less use of rescue morphine when a combined PSP/IPP-block is used for postoperative analgesia in breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2023 Sep 1;40(9):636-642. doi: 10.1097/EJA.0000000000001795. Epub 2023 Jan 12.
- Individual participant dataSharing planned: No
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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.
Joakim Johansson, PhD principal investigator
Umea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine 5 mg/ml, 35 ml, Remifentanil 50 microg/ml and Betamethason 4 mg in people with Breast Neoplasm Female and Regional Anesthesia, run by Umeå University at 1 site in Sweden.
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 0 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 4 Jun 2021. 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 Sweden. 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?
Opiate consumption (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03117894, which also lists 1 linked publication.
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 4 Jun 2021.