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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition Surgery
Interventions Drug: .9 normal saline placebo
Drug: Group L (lidocaine)
Enrollment 148
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lidocaine (Group L) .9% Normal Saline Placebo
Hide Arm/Group Description 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.

.9% normal saline administered as a bolus then as a maintenance infusion for the length of the surgical case.

.9 normal saline placebo: Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure.

Period Title: 24 Hour Assessment
Started 75 75
Completed 74 74
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Period Title: 3 Month Follow up
Started 74 74
Completed 43 40
Not Completed 31 34
Reason Not Completed
Lost to Follow-up             31             34
Arm/Group Title Group L .9% Normal Saline Placebo Total
Hide Arm/Group Description

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 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.

.9% normal saline administered as a bolus then as a maintenance infusion for the length of the surgical case.

.9 normal saline placebo: Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure.

Total of all reporting groups
Overall Number of Baseline Participants 75 75 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
75
 100.0%
75
 100.0%
150
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Female
75
 100.0%
75
 100.0%
150
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
White 58 60 118
African American 12 10 22
Asian 2 3 5
Hispanic 2 2 4
Other 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 75 participants 75 participants 150 participants
75 75 150
Body Mass Index (BMI)   [1] 
Mean (Full Range)
Unit of measure:  Kg/mg^2
Number Analyzed 75 participants 75 participants 150 participants
24
(21 to 29)
25
(22 to 30)
24.5
(21 to 30)
[1]
Measure Description: BMI =(weight in kilograms) / height in meters²
1.Primary Outcome
Title Number of Participants With Chronic Persistent Pain 3 Months After Surgery as Determined by Character Severity (Yes/no).
Hide Description The participants development of chronic persistent pain 3 months after surgery as determined by character severity (yes/no).
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group L .9% Normal Saline Placebo
Hide Arm/Group Description:

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 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.

.9% normal saline administered as a bolus then as a maintenance infusion for the length of the surgical case.

.9 normal saline placebo: Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure.

Overall Number of Participants Analyzed 43 40
Measure Type: Number
Unit of Measure: participants
2 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group L, .9% Normal Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .19
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Quality of Recovery
Hide Description 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.
Time Frame 24 hours post operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine (Group L) .9% Normal Saline Placebo
Hide Arm/Group Description:

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.

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.

.9% normal saline administered as a bolus then as a maintenance infusion for the length of the surgical case.

.9 normal saline placebo: Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure.

Overall Number of Participants Analyzed 74 74
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
158
(147 to 178)
169
(151 to 176)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lidocaine (Group L), .9% Normal Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Post-surgical Persistent Pain Using Validated Questionnaires (S-LANNS Questionnaire, McGill Questionnaire, Brief Pain Inventory) to Assess Pain Qualities in Accordance With IMMPACT Recommendations.
Hide Description 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).
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group L .9% Normal Saline Placebo
Hide Arm/Group Description:

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 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.

.9% normal saline administered as a bolus then as a maintenance infusion for the length of the surgical case.

.9 normal saline placebo: Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure.

Overall Number of Participants Analyzed 43 40
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
S-LANNS
3
(0 to 10)
3
(0 to 8)
McGill Questionaire-Sensory Discrimation
4
(1 to 7)
3
(1 to 7)
McGill Questionaire-Motivational-affective
0
(0 to 1)
0
(0 to 2)
Brief Pain Inventory
1
(0 to 3)
1
(0 to 3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group L, .9% Normal Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group L, .9% Normal Saline Placebo
Comments McGill Questionnaire-Sensory-discriminative dimension
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group L, .9% Normal Saline Placebo
Comments McGill Questionnaire-affective dimension
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group L, .9% Normal Saline Placebo
Comments Brief Pain Inventory
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Opioid Consumption
Hide Description The amount of opioid analgesics consumed was converted to an equivalent dose of intravenous morphine.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group L .9% Normal Saline Placebo
Hide Arm/Group Description:

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 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.

.9% normal saline administered as a bolus then as a maintenance infusion for the length of the surgical case.

.9 normal saline placebo: Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure.

Overall Number of Participants Analyzed 74 74
Median (Inter-Quartile Range)
Unit of Measure: equivalent dose of intravenous morphine
34
(17 to 46)
39
(21 to 57)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group L, .9% Normal Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .19
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Postoperative Pain
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group L .9% Normal Saline Placebo
Hide Arm/Group Description:

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 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.

.9% normal saline administered as a bolus then as a maintenance infusion for the length of the surgical case.

.9 normal saline placebo: Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure.

Overall Number of Participants Analyzed 74 74
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
116
(88 to 142)
119
(91 to 148)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group L, .9% Normal Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .29
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 24 hours after surgery completion.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group L .9% Normal Saline Placebo
Hide Arm/Group Description

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 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.

.9% normal saline administered as a bolus then as a maintenance infusion for the length of the surgical case.

.9 normal saline placebo: Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure.

All-Cause Mortality
Group L .9% Normal Saline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Group L .9% Normal Saline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/74 (0.00%)   0/74 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group L .9% Normal Saline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/74 (0.00%)   0/74 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gildasio De Oliveira, M.D.
Organization: Northwestern University
Phone: 312-695-4858
EMail: gjr@northwestern.edu
Layout table for additonal information
Responsible Party: Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier: NCT01619852    
Other Study ID Numbers: STU00061676
First Submitted: June 12, 2012
First Posted: June 14, 2012
Results First Submitted: January 25, 2016
Results First Posted: November 27, 2019
Last Update Posted: November 27, 2019