Clinical trial NCT01619852: Lidocaine and Prevention of Chronic Pain
Official title: The Effect of Lidocaine to Prevent the Development of Chronic Post-Surgical Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: Surgery
Breast
Pain
Chronic Pain
Lidocaine
Anesthesia
Gynecologic
Urologic
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-06-14
Enrollment: 148
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Eligibility criteria: Inclusion Criteria:

* Age 18-64,
* Females undergoing gynecological, urological or breast surgery

Exclusion Criteria:

* pregnant,
* history of chronic use of opioids,
* allergy to local anesthetics,
* history of cardiac arrhythmias Drop out: patient or surgeon request

Primary outcomes:
measure: Number of Participants With Chronic Persistent Pain 3 Months After Surgery as Determined by Character Severity (Yes/no).
timeFrame: 3 months
Secondary outcomes:
measure: Quality of Recovery
timeFrame: 24 hours post operative
measure: Post-surgical Persistent Pain Using Validated Questionnaires (S-LANNS Questionnaire, McGill Questionnaire, Brief Pain Inventory) to Assess Pain Qualities in Accordance With IMMPACT Recommendations.
timeFrame: 3 months
measure: Opioid Consumption
timeFrame: 24 hours
measure: Postoperative Pain
timeFrame: 24 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Prentice Womens' Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Gildasio De Oliveira, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1) Eric J. Visser. Chronic post-surgical pain: Epidemiology and clinical implications for acute pain management. Acute Pain.2006:8; 73-81
citation: Phillips CJ, Harper C. The economics associated with persistent pain. Curr Opin Support Palliat Care. 2011 Jun;5(2):127-30. doi: 10.1097/SPC.0b013e3283458fa9.
citation: Amr YM, Yousef AA. Evaluation of efficacy of the perioperative administration of Venlafaxine or gabapentin on acute and chronic postmastectomy pain. Clin J Pain. 2010 Jun;26(5):381-5. doi: 10.1097/AJP.0b013e3181cb406e.
citation: Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.
citation: Attal N, Gaude V, Brasseur L, Dupuy M, Guirimand F, Parker F, Bouhassira D. Intravenous lidocaine in central pain: a double-blind, placebo-controlled, psychophysical study. Neurology. 2000 Feb 8;54(3):564-74. doi: 10.1212/wnl.54.3.564.