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PECS-2 for Breast Surgery

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ClinicalTrials.gov Identifier: NCT03117894
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Umeå University

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.


Condition or disease Intervention/treatment Phase
Breast Neoplasm Female Regional Anesthesia Anesthesia Regional Anesthesia Morbidity Anesthesia Morbidity Drug: Ropivacain 5 mg/ml, 35 ml Drug: Remifentanil 50 mikrog/ml Drug: Betametason 4 mg Drug: Paracetamol 1,5 g Drug: Propofol Drug: Arcoxia, 120 mg Drug: Ondansetron 4 mg Drug: Morphine Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Regional Anesthesia for Breast Cancer Surgery, Effects on Postoperative Wellbeing and Disease Recurrence.
Actual Study Start Date : May 23, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: GA with RA
Regional Anesthesia and General Anesthesia.
Drug: Ropivacain 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 mikrog/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: Betametason 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 Name: 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 mikrog/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: Betametason 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 Name: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Postoperative Nausea and Vomiting (PONV) [ Time Frame: 48 hours ]
    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

  2. Actual pain score [ Time Frame: 48 hours ]
    To see if patients with a regional anesthesia have more or less pain than patients with intravenous Morphine as postoperative analgesia.

  3. Recurrence of breast neoplasm [ Time Frame: 3 and 5 years ]
    Recurrence of breast neoplasm



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 NYHA (New York Heart Association) IIIB or worse

Chronic renal failure (S-creatinine increased)

Immunosuppression (more than 10 mg daily of Prednisolone or stronger medication)

No axillary exploration planned


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117894


Contacts
Contact: Joakim Johansson, PhD +46 153000 joakim.johansson@regionjh.se
Contact: Hans Ahlberg, MD +46 153000 hans.ahlberg@regionjh.se

Locations
Sweden
Östersund Hospital Recruiting
Östersund, Jämtland, Sweden, 83183
Contact: Hans Ahlberg, MD    +4663153000    hans.ahlberg@regionjh.se   
Contact: Joakim Johansson, PhD    +46703976410    joakim.johansson@regionjh.se   
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Joakim Johansson, PhD Umea University

Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT03117894     History of Changes
Other Study ID Numbers: UmeaU-PECS
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anesthetics
Propofol
Remifentanil
Morphine
Ondansetron
Acetaminophen
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents