Trial Outcomes & Findings for Lidocaine and Prevention of Chronic Pain (NCT NCT01619852)

NCT ID: NCT01619852

Last Updated: 2019-11-27

Results Overview

The participants development of chronic persistent pain 3 months after surgery as determined by character severity (yes/no).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 148 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2019-11-27

Participant Flow

Participant milestones

Measure	Lidocaine (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 Placebo .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.
24 Hour Assessment STARTED	75	75
24 Hour Assessment COMPLETED	74	74
24 Hour Assessment NOT COMPLETED	1	1
3 Month Follow up STARTED	74	74
3 Month Follow up COMPLETED	43	40
3 Month Follow up NOT COMPLETED	31	34

Reasons for withdrawal

Measure	Lidocaine (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 Placebo .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.
24 Hour Assessment Withdrawal by Subject	1	1
3 Month Follow up Lost to Follow-up	31	34

Baseline Characteristics

Lidocaine and Prevention of Chronic Pain

Baseline characteristics by cohort

Measure	Group L n=75 Participants 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 Placebo n=75 Participants .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 n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=5 Participants	75 Participants n=7 Participants	150 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	75 Participants n=7 Participants	150 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	58 participants n=5 Participants	60 participants n=7 Participants	118 participants n=5 Participants
Race/Ethnicity, Customized African American	12 participants n=5 Participants	10 participants n=7 Participants	22 participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants	75 participants n=7 Participants	150 participants n=5 Participants
Body Mass Index (BMI)	24 kg/mg^2 n=5 Participants	25 kg/mg^2 n=7 Participants	24.5 kg/mg^2 n=5 Participants

PRIMARY outcome

Timeframe: 3 months

The participants development of chronic persistent pain 3 months after surgery as determined by character severity (yes/no).

Outcome measures

Measure	Group L n=43 Participants 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 Placebo n=40 Participants .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.
Number of Participants With Chronic Persistent Pain 3 Months After Surgery as Determined by Character Severity (Yes/no).	2 participants	6 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Group L n=74 Participants 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 Placebo n=74 Participants .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.
Quality of Recovery	158 units on a scale Interval 147.0 to 178.0	169 units on a scale Interval 151.0 to 176.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Group L n=43 Participants 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 Placebo n=40 Participants .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.
Post-surgical Persistent Pain Using Validated Questionnaires (S-LANNS Questionnaire, McGill Questionnaire, Brief Pain Inventory) to Assess Pain Qualities in Accordance With IMMPACT Recommendations. McGill Questionaire-Motivational-affective	0 units on a scale Interval 0.0 to 1.0	0 units on a scale Interval 0.0 to 2.0
Post-surgical Persistent Pain Using Validated Questionnaires (S-LANNS Questionnaire, McGill Questionnaire, Brief Pain Inventory) to Assess Pain Qualities in Accordance With IMMPACT Recommendations. Brief Pain Inventory	1 units on a scale Interval 0.0 to 3.0	1 units on a scale Interval 0.0 to 3.0
Post-surgical Persistent Pain Using Validated Questionnaires (S-LANNS Questionnaire, McGill Questionnaire, Brief Pain Inventory) to Assess Pain Qualities in Accordance With IMMPACT Recommendations. S-LANNS	3 units on a scale Interval 0.0 to 10.0	3 units on a scale Interval 0.0 to 8.0
Post-surgical Persistent Pain Using Validated Questionnaires (S-LANNS Questionnaire, McGill Questionnaire, Brief Pain Inventory) to Assess Pain Qualities in Accordance With IMMPACT Recommendations. McGill Questionaire-Sensory Discrimation	4 units on a scale Interval 1.0 to 7.0	3 units on a scale Interval 1.0 to 7.0

SECONDARY outcome

Timeframe: 24 hours

The amount of opioid analgesics consumed was converted to an equivalent dose of intravenous morphine.

Outcome measures

Measure	Group L n=74 Participants 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 Placebo n=74 Participants .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.
Opioid Consumption	34 equivalent dose of intravenous morphine Interval 17.0 to 46.0	39 equivalent dose of intravenous morphine Interval 21.0 to 57.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Group L n=74 Participants 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 Placebo n=74 Participants .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.
Postoperative Pain	116 score on a scale Interval 88.0 to 142.0	119 score on a scale Interval 91.0 to 148.0

Adverse Events

Group L

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

.9% Normal Saline Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gildasio De Oliveira, M.D.

Northwestern University

Phone: 312-695-4858

Email: gjr@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place