Local Anesthetic for Total Mastectomy Surgery

Analgesic Effects of Local Anesthetic Serratus Plane Infiltration for Total Mastectomy Surgery: A Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Breast Pain
• Intervention / Treatment: Drug: Local Anesthetic Injection above the serratus anterior

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subjective Visual Analogue Scale (VAS)	The visual analogue scale is administered at different time points	7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Adverse Event Outcomes	The visual analogue scale is administered at different time points	72 hours post operatively

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2016
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (ESTIMATE): September 8, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 8, 2016
• Last Update Submitted That Met QC Criteria: September 1, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mastodynia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 16-5729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: publication