- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02544282
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
Study Overview
Status
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Antwerpen
-
Wilrijk, Antwerpen, Belgium, 2610
- Gza Sint Augustinus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pecs II
General anesthesia followed by a Pecs II block and opioids if required
|
General Anesthesia
Pecs II Block
Other Names:
General Anesthesia
General Anesthesia
General Anesthesia
Pain Relief
Other Names:
Pain Relief
Pain Relief
|
Placebo Comparator: Placebo
General anesthesia followed by a placebo Pecs II block and opioids if required
|
General Anesthesia
General Anesthesia
General Anesthesia
General Anesthesia
Pain Relief
Other Names:
Pain Relief
Pain Relief
Placebo Pecs II block
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 72 hours after completion of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Peroperative period (max. 5 hours)
|
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
|
up to 72 hours after completion of surgery
|
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
|
up to 72 hours after completion of surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Barbara JB Versyck, MD, GZA Ziekenhuizen campus Sint-Augustinus
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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