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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02544282
Recruitment Status : Completed
First Posted : September 9, 2015
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
GZA Ziekenhuizen Campus Sint-Augustinus

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Postoperative Nausea and Vomiting Drug: Levobupivacaine Drug: NaCl 0.9% Drug: Sevoflurane Drug: Propofol Drug: Sufentanil Drug: Atracurium Drug: Paracetamol Drug: Tramadol Drug: Piritramide Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery: Effect on Postoperative Pain and Opioid Consumption
Study Start Date : April 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pecs II
General anesthesia followed by a Pecs II block and opioids if required
Drug: Levobupivacaine
Pecs II Block
Other Name: Chirocaine

Drug: Sevoflurane
General Anesthesia

Drug: Propofol
General Anesthesia

Drug: Sufentanil
General Anesthesia

Drug: Atracurium
General Anesthesia

Drug: Paracetamol
Pain Relief
Other Name: 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: NaCl 0.9%
Placebo Pecs II block
Other Name: Normal Saline

Drug: Sevoflurane
General Anesthesia

Drug: Propofol
General Anesthesia

Drug: Sufentanil
General Anesthesia

Drug: Atracurium
General Anesthesia

Drug: Paracetamol
Pain Relief
Other Name: Acetaminophen

Drug: Tramadol
Pain Relief

Drug: Piritramide
Pain Relief




Primary Outcome Measures :
  1. Postoperative Pain [ Time Frame: up to 72 hours after completion of surgery ]
    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


Secondary Outcome Measures :
  1. Peroperative Opioid Consumption [ Time Frame: Peroperative period (max. 5 hours) ]
    Anesthetist in charge reports Opioid Consumption. Master data set is administrated by secretarial office of Anesthesia department

  2. Postoperative Opioid Consumption [ Time Frame: up to 72 hours after completion of surgery ]
    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

  3. Postoperative Nausea and Vomiting [ Time Frame: up to 72 hours after completion of surgery ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02544282


Locations
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Belgium
GZA Sint Augustinus
Wilrijk, Antwerpen, Belgium, 2610
Sponsors and Collaborators
GZA Ziekenhuizen Campus Sint-Augustinus
Investigators
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Principal Investigator: Barbara JB Versyck, MD GZA Ziekenhuizen Campus Sint-Augustinus

Publications of Results:
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Responsible Party: GZA Ziekenhuizen Campus Sint-Augustinus
ClinicalTrials.gov Identifier: NCT02544282    
Other Study ID Numbers: GZA-ANE-PECS-01
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: October 2015
Keywords provided by GZA Ziekenhuizen Campus Sint-Augustinus:
Analgesics
Opioid
Mastectomy
Segmental Mastectomy
Pecs II
Additional relevant MeSH terms:
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Vomiting
Pain, Postoperative
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Sufentanil
Analgesics, Opioid
Tramadol
Pirinitramide
Anesthetics
Propofol
Sevoflurane
Levobupivacaine
Atracurium
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation