Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery

Patients will be recruited up to 21 days prior to the day of surgery. The consent form
will be reviewed with the patient, and the patient will be allowed to take a copy home. If
the patient does not have an EKG within the past 6 weeks in her medical record, an EKG will
be obtained at the time of recruitment. At the time of recruitment, the patient will be
randomized using a computer-generated code. Group A will receive lidocaine during surgery,
and Group B will receive saline (placebo) during surgery.The study drug will be prepared by
the investigator(s). The anesthesiologist and research nurse will be blinded. If necessary
in the event of an emergency, these individuals may be unblinded.

Group A (Lidocaine):

Induction: 1.5 mg/kg IV (IBW) bolus, administered prior to Propofol. The maximum loading
dose administered will not exceed 150 mg IV Infusion: 33.3 mcg/kg/min IV (IBW), initiated
before surgical incision.Discontinue infusion 1 hour after skin closure complete.No other
local anesthetics administered intra-operatively

Group B (Saline):

Induction: IV bolus, administered prior to Propofol Infusion: Initiate before surgical
incision (rate calculated as if for lidocaine infusion). Discontinue infusion 1 hour after
skin closure complete No local anesthetics administered intra-operatively. Baseline thermal
quantitative sensory testing (QST) scores will be obtained pre-operatively using TSA-II
Neuro Sensory Analyzer (Medoc Advanced Medical Systems, Durham, NC).

Baseline Modified Quality of Recovery (MQoR-40) Survey will be obtained on the morning of
surgery.

Preoperative anxiety, depression, and pain characterization will be measured within 24 hours
of the time of surgery using a validated questionnaire (Hospital Anxiety and Depression
Scale). If the questionnaire responses indicate the patient is experiencing depressive
symptoms, the patient will be notified of the results and instructed to follow up with her
primary care physician.

Intraoperatively, patients will receive a standardized anesthetic (management protocol
attached).

Two blood samples for lidocaine levels will be obtained on subjects. The first lidocaine
blood sample will be collected after the lidocaine/placebo bolus in the operating room. The
second lidocaine blood sample will be obtained when the lidocaine/placebo infusion has been
discontinued (one hour after skin closure). A total of 5 mLs of blood will be obtained.

Patients will be examined daily by a research nurse while admitted to the hospital. Daily
pain scores will be noted, as will complications related to the perioperative period. If the
subject is discharged within 24 hours the research nurse will call by phone to ask the
subject about pain 0-10 and type and amount of pain relievers used since discharge.MQoR-40
will be administered on the day of discharge. It will be repeated at 6 weeks, 6 months, and
12 months after surgery. Patients will complete the Mastectomy Patient Follow-Up, Modified
LANNS Pain Scale, and McGill Pain questionnaires at 6 months and 12 months after surgery for
detection of Post-Mastectomy Pain Syndrome (PMPS).

The definition of PMPS will be: The presence of a dull, burning,and aching sensation in the
anterior chest, arm, and axilla exacerbated by movement of the shoulder girdle.

Appendix 1—Anesthetic Management Protocol Appendix 2—HADS Appendix 3—MQoR-40 Appendix
4—Modified LANNS and McGill Appendix 5—Follow-Up Questionnaire