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Local Anesthetic for Total Mastectomy 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: 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
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Breast Pain Drug: Local Anesthetic Injection above the serratus anterior Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Change in subjective Visual Analogue Scale (VAS) [ Time Frame: 7 days after surgery ]
    The visual analogue scale is administered at different time points


Secondary Outcome Measures :
  1. Patient Adverse Event Outcomes [ Time Frame: 72 hours post operatively ]
    The visual analogue scale is administered at different time points



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT02893384


Contacts
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Contact: Rongyu Jin, MD 416-603-5800 ext 2016 rongyu.jin@uhn.ca

Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Vincent Chan, MD Toronto Western Hospital, University Health Network, University of Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02893384    
Other Study ID Numbers: 16-5729
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publication
Additional relevant MeSH terms:
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Mastodynia
Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents