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Lidocaine and Prevention of Chronic Pain

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ClinicalTrials.gov Identifier: NCT01619852
Recruitment Status : Completed
First Posted : June 14, 2012
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University

Tracking Information
First Submitted Date  ICMJE June 12, 2012
First Posted Date  ICMJE June 14, 2012
Results First Submitted Date  ICMJE January 25, 2016
Results First Posted Date  ICMJE November 27, 2019
Last Update Posted Date November 27, 2019
Study Start Date  ICMJE June 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
Number of Participants With Chronic Persistent Pain 3 Months After Surgery as Determined by Character Severity (Yes/no). [ Time Frame: 3 months ]
The participants development of chronic persistent pain 3 months after surgery as determined by character severity (yes/no).
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2012)
The development of chronic pain after surgery [ Time Frame: 6 months ]
The participants development of chronic pain 6 months after surgery.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
  • Quality of Recovery [ Time Frame: 24 hours post operative ]
    Quality of recovery (QoR-40 instrument) is a 40-item questionnaire that provides a global score and sub-scores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Score range: 40 to 200. A score of 40 demonstrates poor recovery and a maximum score of 200 represents good recovery. The higher the score the better recovery after surgery.
  • Post-surgical Persistent Pain Using Validated Questionnaires (S-LANNS Questionnaire, McGill Questionnaire, Brief Pain Inventory) to Assess Pain Qualities in Accordance With IMMPACT Recommendations. [ Time Frame: 3 months ]
    The development of chronic pain 3 months after surgery determined by the Leads Assessment of Neuropathic Symptoms and Signs (LANSS) scale, a valid 7-item tool for identifying patients whose pain is dominated by neuropathic mechanisms. Each item is a binary response (yes or no) to the presence of symptoms (5 items) or clinical signs (2 items), range 0-24 points. A score ≥ 12, neuropathic mechanisms are likely to be contributing to the patient's pain. A score < 12 is unlikely to be contributing. McGill questionnaire (Sensory domain) - 11 descriptors rated on an intensity scale as 0=none, 1=mild, 2=moderate, 3=severe. The higher the score, greater the pain (range 0-33). McGill questionnaire (Motivational-affective) 4 affect descriptors rated on an intensity scale as 0=none, 1=mild, 2=moderate, 3=severe.The higher the score the greater the pain (range 0-12) Brief pain inventory - pain severity (0, no pain, 10 excruciating pain); Greater the score; greater the pain (range 0-10).
  • Opioid Consumption [ Time Frame: 24 hours ]
    The amount of opioid analgesics consumed was converted to an equivalent dose of intravenous morphine.
  • Postoperative Pain [ Time Frame: 24 hours ]
    Postoperative pain within the first 24 hours. Area under the numeric rating scale for pain versus time curve during the first 24 hours after surgery (score * hr). Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve during the first 24 hours ( score * hr). The pain scores were collected upon arrival to recovery area, 30 minutes, 1 hour and every 6 hours up to 24 hours following the procedure. Minimum score is 60, Maximum score is 170. A higher value indicates more pain.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2012)
Brain morphologic and functional changes associated with the development of chronic pain [ Time Frame: 6 months ]
Brain morphologic and functional changes associated with the development of chronic pain at 6 months post surgery.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lidocaine and Prevention of Chronic Pain
Official Title  ICMJE The Effect of Lidocaine to Prevent the Development of Chronic Post-Surgical Pain
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Surgery
Intervention  ICMJE
  • Drug: .9 normal saline placebo
    Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure.
  • Drug: Group L (lidocaine)
    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.
Study Arms  ICMJE
  • Active Comparator: Group L
    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: Drug: Group L (lidocaine)
  • Placebo Comparator: .9% normal saline placebo
    .9% normal saline administered as a bolus then as a maintenance infusion for the length of the surgical case.
    Intervention: Drug: .9 normal saline placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2019)
148
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2012)
300
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01619852
Other Study ID Numbers  ICMJE STU00061676
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gildasio De Oliveira, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gildasio De Oliveira, M.D. Northwestern University
PRS Account Northwestern University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP