Local Anesthetic for Total Mastectomy Surgery
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|ClinicalTrials.gov Identifier: NCT02893384|
Recruitment Status : Unknown
Verified September 2016 by University Health Network, Toronto.
Recruitment status was: Not yet recruiting
First Posted : September 8, 2016
Last Update Posted : September 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Pain||Drug: Local Anesthetic Injection above the serratus anterior||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Analgesic Effects of Local Anesthetic Serratus Plane Infiltration for Total Mastectomy Surgery: A Pilot Study|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: Local Anesthetic Injection
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
Drug: Local Anesthetic Injection above the serratus anterior
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.
Other Name: Injection to serratus anterior muscle at the end of surgery
No Intervention: Control Arm
Retrospective control group who have not had the new injection technique.
- Change in subjective Visual Analogue Scale (VAS) [ Time Frame: 7 days after surgery ]The visual analogue scale is administered at different time points
- Patient Adverse Event Outcomes [ Time Frame: 72 hours post operatively ]The visual analogue scale is administered at different time points
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): NCT02893384
|Contact: Rongyu Jin, MD||416-603-5800 ext firstname.lastname@example.org|
|Principal Investigator:||Vincent Chan, MD||Toronto Western Hospital, University Health Network, University of Toronto|