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PECS-2 for Breast Surgery

Primary Purpose

Breast Neoplasm Female, Regional Anesthesia, Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Ropivacaine 5 mg/ml, 35 ml
Remifentanil 50 microg/ml
Betamethason 4 mg
Paracetamol 1,5 g
Propofol
Arcoxia, 120 mg
Ondansetron 4 mg
Morphine
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasm Female

Eligibility Criteria

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

Inclusion Criteria: Unilateral surgery on the breast because of suspected malign disease.

Exclusion Criteria:

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

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

Sites / Locations

  • Östersund Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

GA with RA

GA without RA

Arm Description

Regional Anesthesia and General Anesthesia.

Only General Anesthesia (without a supplemental Regional Anesthesia).

Outcomes

Primary Outcome Measures

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.
All cause mortality
This is to investigate the possible effect that a regional anesthesia may have on recurrence of a malignant tumor.

Secondary Outcome Measures

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
Actual pain score
To see if patients with a regional anesthesia have more or less pain than patients with intravenous Morphine as postoperative analgesia.
Recurrence of breast neoplasm
Recurrence of breast neoplasm
Chronic Pain
Pain after 6 months as assessed in a telephone interview, measured as Numeric Rate Scale (0-10).

Full Information

First Posted
March 6, 2017
Last Updated
May 31, 2021
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT03117894
Brief Title
PECS-2 for Breast Surgery
Official Title
Regional Anesthesia for Breast Cancer Surgery, Effects on Postoperative Wellbeing and Disease Recurrence.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 23, 2017 (Actual)
Primary Completion Date
October 22, 2020 (Actual)
Study Completion Date
October 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female, Regional Anesthesia, Anesthesia, Regional Anesthesia Morbidity, Anesthesia Morbidity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GA with RA
Arm Type
Active Comparator
Arm Description
Regional Anesthesia and General Anesthesia.
Arm Title
GA without RA
Arm Type
Active Comparator
Arm Description
Only General Anesthesia (without a supplemental Regional Anesthesia).
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 5 mg/ml, 35 ml
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Remifentanil 50 microg/ml
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Betamethason 4 mg
Intervention Description
Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered preoperatively.
Intervention Type
Drug
Intervention Name(s)
Paracetamol 1,5 g
Other Intervention Name(s)
Prevention of pain
Intervention Description
Administered preoperatively to prevent pain postoperatively.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Arcoxia, 120 mg
Intervention Description
Administered preoperatively to prevent pain postoperatively.
Intervention Type
Drug
Intervention Name(s)
Ondansetron 4 mg
Intervention Description
Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered peroperative.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Administered peroperative, at the end of the surgery, before awakening the study participant. The aim is to prevent pain.
Primary Outcome Measure Information:
Title
Opiate consumption
Description
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.
Time Frame
48 hours
Title
All cause mortality
Description
This is to investigate the possible effect that a regional anesthesia may have on recurrence of a malignant tumor.
Time Frame
3 years and 5 years.
Secondary Outcome Measure Information:
Title
Postoperative Nausea and Vomiting (PONV)
Description
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
Time Frame
48 hours
Title
Actual pain score
Description
To see if patients with a regional anesthesia have more or less pain than patients with intravenous Morphine as postoperative analgesia.
Time Frame
48 hours
Title
Recurrence of breast neoplasm
Description
Recurrence of breast neoplasm
Time Frame
3 and 5 years
Title
Chronic Pain
Description
Pain after 6 months as assessed in a telephone interview, measured as Numeric Rate Scale (0-10).
Time Frame
6 (5-7) months after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral surgery on the breast because of suspected malign disease. Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joakim Johansson, PhD
Organizational Affiliation
Umea University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Östersund Hospital
City
Östersund
State/Province
Jämtland
ZIP/Postal Code
83183
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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PECS-2 for Breast Surgery

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