Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery

NCT02544282 | Completed Phase 4

• 1 other identifier: GZA-ANE-PECS-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with axillary node dissection will be randomly assigned to general anesthesia with opioids combined with a Pecs II block or to general anesthesia with opioids combined with a placebo Pecs II block. Participants will be followed postoperatively during their entire hospital stay to determine the effectiveness of Pecs II block and opioids versus placebo Pecs II block and opioids as postoperative pain treatment.

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Keywords

Analgesics; Opioid; Mastectomy; Segmental Mastectomy; Pecs II

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  Within first hour: Each ten minutes by Recovery Nurse. Hour 2 till discharge ( max 72 hours post surgery): hourly by patient through questionnaire.Master data set is administrated by secretarial office of Anesthesia departement

  up to 72 hours after completion of surgery

Secondary Outcomes (3)

• Peroperative Opioid Consumption

  Peroperative period (max. 5 hours)

• Postoperative Opioid Consumption

  up to 72 hours after completion of surgery

• Postoperative Nausea and Vomiting

  up to 72 hours after completion of surgery

Study Arms (2)

Pecs II

ACTIVE COMPARATOR

General anesthesia followed by a Pecs II block and opioids if required

Drug: Levobupivacaine; Drug: Sevoflurane; Drug: Propofol; Drug: Sufentanil; Drug: Atracurium; Drug: Paracetamol; Drug: Tramadol; Drug: Piritramide

Placebo

PLACEBO COMPARATOR

General anesthesia followed by a placebo Pecs II block and opioids if required

Drug: NaCl 0.9%; Drug: Sevoflurane; Drug: Propofol; Drug: Sufentanil; Drug: Atracurium; Drug: Paracetamol; Drug: Tramadol; Drug: Piritramide

Interventions

Levobupivacaine DRUG

Pecs II Block

Also known as: Chirocaine

Pecs II

NaCl 0.9% DRUG

Placebo Pecs II block

Also known as: Normal Saline

Placebo

Sevoflurane DRUG

General Anesthesia

Pecs II; Placebo

Propofol DRUG

General Anesthesia

Pecs II; Placebo

Sufentanil DRUG

General Anesthesia

Pecs II; Placebo

Atracurium DRUG

General Anesthesia

Pecs II; Placebo

Paracetamol DRUG

Pain Relief

Also known as: Acetaminophen

Pecs II; Placebo

Tramadol DRUG

Pain Relief

Pecs II; Placebo

Piritramide DRUG

Pain Relief

Pecs II; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary breast cancer without known extension beyond the breast and axillary nodes (i.e. believed to be Tumor Stage 1-3, Nodes 0-2)
• Scheduled for unilateral or bilateral mastectomy with or without implant (isolated "lumpectomy" will not qualify)
• Isolated "lumpectomy" with axillary node dissection (anticipated removal of at least five nodes)
• Written informed consent, including willingness to be randomized to opioids or regional analgesia
• Dutch speaking

You may not qualify if:

• Previous surgery for breast cancer (except diagnostic biopsies)
• Inflammatory breast cancer
• Scheduled free flap reconstruction
• ASA Physical Status ≥ 4
• Any contraindication to locoregional analgesia (including coagulopathy, abnormal anatomy)
• Any contraindication to midazolam, propofol, sevoflurane, sufentanyl, tramadol or piritramide
• Other cancer not believed by the attending surgeon to be in long-term remission
• Systemic disease believed by the attending surgeon to present ≥ 25% two-year mortality
• Obesity defined as BMI ≥ 30 kg/m2
• Chronic use of pain medication (started \> 3 months ago)
• Allergic to Chirocaine
• Chronic drug or alcohol abuse
• INR \> 1.4
• Thrombocytopenia \< 70,000 platelets
• Dementia

Sponsors & Collaborators

• GZA Ziekenhuizen Campus Sint-Augustinus: lead

Study Sites (1)

GZA Sint Augustinus

Wilrijk, Antwerpen, 2610, Belgium

Location

Related Publications (1)

• Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

  PMID: 22939099 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Levobupivacaine; Sodium Chloride; Saline Solution; Sevoflurane; Propofol; Sufentanil; Atracurium; Acetaminophen; Tramadol; Pirinitramide

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzylisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Acetanilides; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids; Isonipecotic Acids; Acids, Heterocyclic

Study Officials

• Barbara JB Versyck, MD

  GZA Ziekenhuizen Campus Sint-Augustinus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 9, 2015
• Study Start: April 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 13, 2016

Record last verified: 2015-10

Locations

BE (1)