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

Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery: Effect on Postoperative Pain and Opioid Consumption

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Postoperative Nausea and Vomiting
• Intervention / Treatment: Drug: Propofol; Drug: Levobupivacaine; Drug: Sevoflurane; Drug: Sufentanil; Drug: Atracurium; Drug: Paracetamol; Drug: Tramadol; Drug: Piritramide; Drug: NaCl 0.9%

Detailed Description

Each year, 9400 new cases of breast cancer are diagnosed in Belgium. It makes breast cancer the most common cancer in women, good for more than one third of all cancer cases in women.

Surgical excision of the tumour is a necessary and effective step to cure from the disease. Recent studies have demonstrated the positive effects of regional anesthesia on peroperative and postoperative pain. Paravertebral blocks have become popular as an alternative to the analgesia provided by the 'gold standard' of thoracic epidural analgesia. However, both regional techniques have complications and slow learning curves that make them unsuitable for the large proportion of breast surgery patients who are treated on a day-stay basis. Recently, Rafael Blanco introduced the Pecs and Pecs II blocks, a practical alternative to both paravertebral and epidural blockade in the management of pain after breast surgery.

The investigators introduced the Pecs II block in their clinical practice. This study compares general anesthesia with a Pecs II block to general anesthesia with a placebo Pecs II block for breast surgery. The objective is to evaluate analgesic effectiveness and changes in opioid consumption when applying a Pecs II block versus a placebo Pecs II block.

Stage 1-3 patients having mastectomies or tumourectomies with axillary clearance will be randomly assigned to general anesthesia with a Pecs II block or to general anesthesia with a placebo Pecs II block. Enrolling 140 patients over an anticipated time frame of 2 years will provide an 90% power and a p-value of 0.05 for perioperative and postoperative opioid consumption as well as pain scores (NRS). Confirming the hypothesis will indicate that a minor modification to the anesthetic procedure will reduce the opioid consumption (including it's unwanted side effects) during and after surgery while maintaining or reducing patients' indicated pain scores (NRS).

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen
    • Wilrijk, Antwerpen, Belgium, 2610
      • Gza Sint Augustinus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Pregnancy
• Kidney or liver failure

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pecs II; General anesthesia followed by a Pecs II block and opioids if required	Drug: Propofol; General Anesthesia; Drug: Levobupivacaine; Pecs II Block; Other Names: Chirocaine; Drug: Sevoflurane; General Anesthesia; Drug: Sufentanil; General Anesthesia; Drug: Atracurium; General Anesthesia; Drug: Paracetamol; Pain Relief; Other Names: Acetaminophen; Drug: Tramadol; Pain Relief; Drug: Piritramide; Pain Relief
Placebo Comparator: Placebo; General anesthesia followed by a placebo Pecs II block and opioids if required	Drug: Propofol; General Anesthesia; Drug: Sevoflurane; General Anesthesia; Drug: Sufentanil; General Anesthesia; Drug: Atracurium; General Anesthesia; Drug: Paracetamol; Pain Relief; Other Names: Acetaminophen; Drug: Tramadol; Pain Relief; Drug: Piritramide; Pain Relief; Drug: NaCl 0.9%; Placebo Pecs II block; Other Names: Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peroperative Opioid Consumption	Anesthetist in charge reports Opioid Consumption. Master data set is administrated by secretarial office of Anesthesia department	Peroperative period (max. 5 hours)
Postoperative Opioid Consumption	Nurse of postoperative recovery room and nurse of ward in charge reports opioid consumption on patient questionnaire. Master data set is administrated by secretarial office of Anesthesia department	up to 72 hours after completion of surgery
Postoperative Nausea and Vomiting	Nurse of postoperative recovery room and nurse of ward in charge reports patients nausea and vomiting as well as the administered medication against postoperative nausea and vomiting on patient questionnaire. Master data set is administrated by secretarial office of Anesthesia department	up to 72 hours after completion of surgery

Collaborators and Investigators

• Sponsor: GZA Ziekenhuizen Campus Sint-Augustinus
• Investigators: Principal Investigator: Barbara JB Versyck, MD, GZA Ziekenhuizen campus Sint-Augustinus

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 2, 2015
• First Submitted That Met QC Criteria: September 8, 2015
• First Posted (Estimate): September 9, 2015

Study Record Updates

• Last Update Posted (Estimate): July 13, 2016
• Last Update Submitted That Met QC Criteria: July 12, 2016
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Opioid; Mastectomy; Analgesics; Segmental Mastectomy; Pecs II
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Nausea; Pain, Postoperative; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Platelet Aggregation Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Local; Anesthetics, Inhalation; Neuromuscular Agents; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Propofol; Acetaminophen; Sevoflurane; Tramadol; Levobupivacaine; Sufentanil; Pirinitramide; Atracurium
• Other Study ID Numbers: GZA-ANE-PECS-01