Lidocaine and Prevention of Chronic Pain
Condition: Surgery
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The study seeks to investigate a safe and inexpensive strategy to reduce persistent
      post-surgical pain that can affect up to 60% of patients undergoing surgical procedures.

      Hypotheses: Perioperative systemic lidocaine reduces the persistence of chronic pain in
      patients undergoing surgical procedures.
    

Detailed description: 
      After approval from Northwestern University's IRB, female subjects undergoing urologic,
      gynecologic or breast surgery will be included in the study. Informed consent will be
      obtained from all participants. Subject will be randomized using a computer generated table
      of random numbers into two groups: Group L will receive a 1.5 mg/kg bolus of intravenous
      lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical
      induction and will be discontinued one hour after the end of the surgical procedure. Group P
      will receive the same amount of saline in the same fashion. This dose regimen of systemic
      lidocaine chosen in the current study has been consistently associated with a reduction of
      acute postoperative pain.4 There will be no visual characteristic differences between any of
      the infusions studied and they will all be labeled as a study drug. Patients will receive a
      standard anesthetic regimen consisting of propofol, fentanyl, succinylcholine, and
      sevoflurane. Patients will receive ondansetron 4mg and dexamethasone 4 mg to prevent
      postoperative nausea and vomiting. They will also receive 10 mcg/kg of hydromorphone at the
      end of surgery to prevent postoperative pain. In the PACU, patients will receive additional
      doses of hydromorphone to keep pain <4/10 (on a scale where 0 means no pain and 10 is the
      worst pain possible). On PACU discharge, patients will receive a patient-controlled IV
      hydromorphone analgesia pump set at 0.2mg IV bolus, no basal infusion and a lockout time of
      15 minutes. The intraoperative and postoperative data (pain scores, opioid consumption, side
      effects) will be collected by a research assistant blinded to the group allocation). Other
      data collection variables include : Preoperative (Age, BMI, ethnicity, comorbidities,
      preoperative medication(s), psychiatric disease, pain in the operative area, pain at other
      locations), Intraoperative (description of surgical procedure, surgical duration, surgical
      procedure on nerve areas, preservation of the nerves in the operative area nerve, indication
      for the surgical procedure, intraoperative opioids dose, and Postoperative pain instruments
      (evaluation of early pain, twenty four hour opioid consumption, drugs and other treatments
      used in the postoperative period.

      QOR 40 questionnaire will be completed by the participant at 24 hours after surgery if they
      have not been discharged from the hospital. If they have been discharged, the research
      assistant will contact the participant by telephone to complete the questionnaire.

      Patients will be evaluated for the presence and severity of chronic pain as well as the
      quality of life impact of pain at baseline, three and six months after surgery using a
      validated instrument in accordance with the IMMPACT recommendations to assess chronic pain
      and its impact on the patient's quality of life (Brief pain Inventory).8 To characterize the
      chronic pain, both the short form McGill pain questionnaire and the Modified LANNS scale will
      be also administered at three and six months.9,10 If there is no response to the 3 month
      questionnaire, the subject will be contacted by telephone to complete the questionnaire.

      Subjects who are experiencing suicidal ideation will be referred to Northwestern Memorial
      Hospital Emergency Department. The primary care surgeon will also be notified by the
      principal investigator. Mood will be assessed using the Beck Depression Inventory.14
    

Intervention name(s): .9 normal saline placebo; Group L (lidocaine)
Intervention type(s): Drug; Drug
Intervention description(s): Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure.; Group L will receive a 1.5 mg/kg bolus of intravenous lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical induction and will be discontinued one hour after the end of the surgical procedure.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Surgery; Breast; Pain; Chronic Pain; Lidocaine; Anesthesia; Gynecologic; Urologic