Clinical trial NCT03117894: PECS-2 for Breast Surgery
Official title: Regional Anesthesia for Breast Cancer Surgery, Effects on Postoperative Wellbeing and Disease Recurrence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Female
Regional Anesthesia
Anesthesia
Regional Anesthesia Morbidity
Anesthesia Morbidity
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Opiate consumption
timeFrame: 48 hours
measure: All cause mortality
timeFrame: 3 years and 5 years.
Secondary outcomes:
measure: Postoperative Nausea and Vomiting (PONV)
timeFrame: 48 hours
measure: Actual pain score
timeFrame: 48 hours
measure: Recurrence of breast neoplasm
timeFrame: 3 and 5 years
measure: Chronic Pain
timeFrame: 6 (5-7) months after surgery
Other outcomes:
Locations:
city: Östersund
country: Sweden
facility: Östersund Hospital
state: Jämtland
Study officials:
affiliation: Umea University
name: Joakim Johansson, PhD
role: PRINCIPAL_INVESTIGATOR
References: