Local Anesthetic for Total Mastectomy Surgery
Primary Purpose
Breast Pain
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Local Anesthetic Injection above the serratus anterior
Sponsored by
About this trial
This is an interventional treatment trial for Breast Pain
Eligibility Criteria
Inclusion Criteria:
- Undergoing elective or urgent, primary, unilateral mastectomy with or without axillary lymph node dissection
- ASA-PS I-III
- 18-85 years of age, inclusive
- 50-100 kg, inclusive
- BMI 18 - 40
Exclusion Criteria:
- Bilateral mastectomy surgery
- Revision mastectomy surgery
- Inability or refusal to provide informed consent
- Chronic pain state
- Neuropathic pain
- Opioid dependence
- Allergy to local anesthesia
- Allergy to opioids
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Local Anesthetic Injection
Control Arm
Arm Description
The intervention involves injection of local anesthetic (0.25% bupivacaine with 1:200,000 epinephrine) under direct vision in the serratus anterior muscle plane at the end of surgery. Local Anesthetic Injection above the serratus anterior
Retrospective control group who have not had the new injection technique.
Outcomes
Primary Outcome Measures
Change in subjective Visual Analogue Scale (VAS)
The visual analogue scale is administered at different time points
Secondary Outcome Measures
Patient Adverse Event Outcomes
The visual analogue scale is administered at different time points
Full Information
NCT ID
NCT02893384
First Posted
August 5, 2016
Last Updated
September 1, 2016
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02893384
Brief Title
Local Anesthetic for Total Mastectomy Surgery
Official Title
Analgesic Effects of Local Anesthetic Serratus Plane Infiltration for Total Mastectomy Surgery: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pain following mastectomy surgery for breast cancer can be significant. Poorly managed pain in the immediate time-period following surgery can potentially lead to long-term (chronic) pain conditions. There is still a need to find the safest, least invasive, and most effective method to manage this pain. The investigators believe that a new technique of injecting local anesthesia (freezing) in to specific areas at the end of mastectomy surgery may be a very important step to managing pain after breast surgery. The investigators would like to begin by performing a pilot study, meaning the investigators will perform the technique in patients and compare what their pain outcomes are to patients who have not had the technique.
Detailed Description
Mastectomy is associated with significant acute postoperative pain. It has been shown that inadequately managed post-mastectomy pain in breast cancer patients can have detrimental physiological, psycho-behavioural, recovery and healthcare utilization consequences. Most significantly, acute postoperative pain appears to be a substantial risk factor for progression to chronic post-surgical pain (CPSP), occurring in up to 68% of patients,, with higher severity of acute pain being linked with a greater progression to CPSP. A multimodal analgesic approach is the optimal method of reducing the risk of progression to CPSP, and there are a number of analgesic techniques that can be used to reduce the incidence of acute postoperative pain. Of the analgesic techniques used, the most common are multimodal systemic analgesia, thoracic paravertebral blockade, thoracic epidural analgesia, local anesthetic wound infiltration, and more recently pecs blocks and serratus plane blocks. The former three techniques are all associated with drawbacks including technical challenges, high risk of adverse effects, and limited evidence to minimize the progression to CPSP states, whilst local anesthetic wound infiltration has highly variable pain outcomes. Therefore, an alternative, safer, and more effective technique would be ideal.
Local infiltration analgesia (LIA) techniques have been demonstrated to be efficacious in joint surgery, whilst injection of local anesthesia in the serratus plane to target some of the intercostal and pectoral nerves may have some benefit in mastectomy surgery. However, nobody has yet performed LIA around these nerves in breast surgery, and the investigators feel that this has enormous potential.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Local Anesthetic Injection
Arm Type
Experimental
Arm Description
The intervention involves injection of local anesthetic (0.25% bupivacaine with 1:200,000 epinephrine) under direct vision in the serratus anterior muscle plane at the end of surgery.
Local Anesthetic Injection above the serratus anterior
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Retrospective control group who have not had the new injection technique.
Intervention Type
Drug
Intervention Name(s)
Local Anesthetic Injection above the serratus anterior
Other Intervention Name(s)
Injection to serratus anterior muscle at the end of surgery
Intervention Description
This is a quantitative pilot study assessing whether a new technique of local anesthesia injection during mastectomy surgery gives better pain outcomes than the standard methods. Patients who meet inclusion criteria will be invited to partake and all patients will have the injection technique. These patients will then be monitored for pain outcomes up to 7 days following the surgery and the results compared with historical results from patients who have already had the surgery.
Primary Outcome Measure Information:
Title
Change in subjective Visual Analogue Scale (VAS)
Description
The visual analogue scale is administered at different time points
Time Frame
7 days after surgery
Secondary Outcome Measure Information:
Title
Patient Adverse Event Outcomes
Description
The visual analogue scale is administered at different time points
Time Frame
72 hours post operatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergoing elective or urgent, primary, unilateral mastectomy with or without axillary lymph node dissection
ASA-PS I-III
18-85 years of age, inclusive
50-100 kg, inclusive
BMI 18 - 40
Exclusion Criteria:
Bilateral mastectomy surgery
Revision mastectomy surgery
Inability or refusal to provide informed consent
Chronic pain state
Neuropathic pain
Opioid dependence
Allergy to local anesthesia
Allergy to opioids
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongyu Jin, MD
Phone
416-603-5800
Ext
2016
Email
rongyu.jin@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Chan, MD
Organizational Affiliation
Toronto Western Hospital, University Health Network, University of Toronto
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
publication
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Local Anesthetic for Total Mastectomy Surgery
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