PECS-2 for Breast Surgery

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia Morbidity; Breast Neoplasm Female; Anesthesia; Regional Anesthesia Morbidity; Regional Anesthesia
• Intervention / Treatment: 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; Drug: Morphine

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Jämtland
    • Östersund, Jämtland, Sweden, 83183
      • Östersund Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GA with RA; Regional Anesthesia and General Anesthesia.	Drug: Ropivacaine 5 mg/ml, 35 ml; 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.; Drug: Remifentanil 50 microg/ml; 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.; Drug: Betamethason 4 mg; Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered preoperatively.; Drug: Paracetamol 1,5 g; Administered preoperatively to prevent pain postoperatively.; Other Names: Prevention of pain; Drug: Propofol; 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.; Drug: Arcoxia, 120 mg; Administered preoperatively to prevent pain postoperatively.; Drug: Ondansetron 4 mg; Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered peroperative.
Active Comparator: GA without RA; Only General Anesthesia (without a supplemental Regional Anesthesia).	Drug: Remifentanil 50 microg/ml; 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.; Drug: Betamethason 4 mg; Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered preoperatively.; Drug: Paracetamol 1,5 g; Administered preoperatively to prevent pain postoperatively.; Other Names: Prevention of pain; Drug: Propofol; 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.; Drug: Arcoxia, 120 mg; Administered preoperatively to prevent pain postoperatively.; Drug: Ondansetron 4 mg; Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered peroperative.; Drug: Morphine; Administered peroperative, at the end of the surgery, before awakening the study participant. The aim is to prevent pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours
All cause mortality	This is to investigate the possible effect that a regional anesthesia may have on recurrence of a malignant tumor.	3 years and 5 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	48 hours
Recurrence of breast neoplasm	Recurrence of breast neoplasm	3 and 5 years
Chronic Pain	Pain after 6 months as assessed in a telephone interview, measured as Numeric Rate Scale (0-10).	6 (5-7) months after surgery

Collaborators and Investigators

• Sponsor: Umeå University
• Investigators: Principal Investigator: Joakim Johansson, PhD, Umea University

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2017
• Primary Completion (Actual): October 22, 2020
• Study Completion (Actual): October 22, 2020

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Analgesics, Opioid; Narcotics; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Hypnotics and Sedatives; Anti-Anxiety Agents; Anesthetics, Local; Cyclooxygenase 2 Inhibitors; Antipruritics; Remifentanil; Propofol; Acetaminophen; Ropivacaine; Morphine; Ondansetron; Etoricoxib
• Other Study ID Numbers: UmeaU-PECS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No