Overview

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

Status:
Terminated
Trial end date:
2011-10-01
Target enrollment:
0
Participant gender:
Female
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Northwestern University
Treatments:
Analgesics
Lidocaine
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