Local Anesthetic for Total Mastectomy Surgery

NCT ID: NCT02893384

Last Updated: 2016-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

Breast Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Local Anesthetic Injection above the serratus anterior

Intervention Type: DRUG

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.

Control Arm

Retrospective control group who have not had the new injection technique.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Injection to serratus anterior muscle at the end of surgery

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Chan, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto Western Hospital, University Health Network, University of Toronto

Central Contacts

Rongyu Jin, MD

Role: CONTACT

rongyu.jin@uhn.ca

416-603-5800 ext. 2016

Other Identifiers

16-5729

Identifier Type: -

Identifier Source: org_study_id