PECS-2 for Breast Surgery

NCT03117894 | Completed

• 1 other identifier: UmeaU-PECS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm Female; Regional Anesthesia; Anesthesia; Regional Anesthesia Morbidity; Anesthesia Morbidity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Postoperative Nausea and Vomiting (PONV)

  48 hours

• Actual pain score

  48 hours

• Recurrence of breast neoplasm

  3 and 5 years

• Chronic Pain

  6 (5-7) months after surgery

Study Arms (2)

GA with RA

ACTIVE COMPARATOR

Regional Anesthesia and General Anesthesia.

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).

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

Interventions

Ropivacaine 5 mg/ml, 35 ml DRUG

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.

GA with RA

Remifentanil 50 microg/ml DRUG

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.

GA with RA; GA without RA

Betamethason 4 mg DRUG

Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered preoperatively.

GA with RA; GA without RA

Paracetamol 1,5 g DRUG

Administered preoperatively to prevent pain postoperatively.

Also known as: Prevention of pain

GA with RA; GA without RA

Propofol DRUG

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.

GA with RA; GA without RA

Arcoxia, 120 mg DRUG

Administered preoperatively to prevent pain postoperatively.

GA with RA; GA without RA

Ondansetron 4 mg DRUG

Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered peroperative.

GA with RA; GA without RA

Morphine DRUG

Administered peroperative, at the end of the surgery, before awakening the study participant. The aim is to prevent pain.

GA without RA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Östersund Hospital

Östersund, Jämtland County, 83183, Sweden

Location

Related Publications (1)

• 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.

  PMID: 36633115 DERIVED

MeSH Terms

Interventions

Ropivacaine; Propofol; Etoricoxib; Ondansetron; Morphine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Joakim Johansson, PhD

  Umea University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: April 18, 2017
• Study Start: May 23, 2017
• Primary Completion: October 22, 2020
• Study Completion: October 22, 2020
• Last Updated: June 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)