Local Anesthetic for Total Mastectomy Surgery

NCT02893384 | Unknown Phase 4

• 1 other identifier: 16-5729
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Pain

Outcome Measures

Primary Outcomes (1)

• Change in subjective Visual Analogue Scale (VAS)

  The visual analogue scale is administered at different time points

  7 days after surgery

Secondary Outcomes (1)

• Patient Adverse Event Outcomes

  72 hours post operatively

Study Arms (2)

Local Anesthetic Injection

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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

Interventions

Local Anesthetic Injection above the serratus anterior 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.

Also known as: Injection to serratus anterior muscle at the end of surgery

Local Anesthetic Injection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing elective or urgent, primary, unilateral mastectomy with or without axillary lymph node dissection
• ASA-PS I-III
• years of age, inclusive
• kg, inclusive
• BMI 18 - 40

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

MeSH Terms

Conditions

Mastodynia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vincent Chan, MD

  Toronto Western Hospital, University Health Network, University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rongyu Jin, MD

CONTACT

416-603-5800; rongyu.jin@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: September 8, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 8, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share