Clinical trial NCT00913003: Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery
Official title: Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Keywords: Lidocaine
Mastectomy
Pain
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine if perioperative systemic lidocaine administration will decrease the amount of opioid analgesics required in women undergoing mastectomy surgery. In addition, patients receiving systemic lidocaine will have a lower incidence of post-mastectomy pain syndrome.

This study will have 2 groups. Participants will be randomized into one of each group. The first group will be administered the drug lidocaine prior to surgery and the second group Group B will be administered saline (salt water). This is a blinded study which means the participant will not know which group they have been assigned. The subjects participation will last 12 months (surveys post operatively).

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Age: 18-65 years
* Gender: Female
* ASA Physical Status I-III
* Non-pregnant
* Surgery: Unilateral total or segmental mastectomy
* Language: English speaking
* Consent: Obtained

Exclusion Criteria:

* Age: Under 18 or over 65 years
* ASA Physical Status \>III
* Pregnancy
* Language: Non-English speaking
* Allergy to Lidocaine or amide local anesthetics
* Contraindication to succinylcholine
* History and/or EKG evidence of conduction defect
* Renal failure (Creatinine \>1.7 mg/dL)
* Patient expected to remain intubated after procedure
* Chronic home opioid or steroid use
* Opioid use within one week prior to procedure
* Drug or alcohol abuse
* Inability to use PCA

Primary outcomes:
measure: 24 Hour Hydromorphone
timeFrame: 24 hour
Secondary outcomes:
measure: Number of Participants Experiencing Post Operative Nausea
timeFrame: Immediate post operative to 48 hours
measure: Number of Participants Experiencing Post Operative Ileus
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Christian Altman, M.D.
role: PRINCIPAL_INVESTIGATOR
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