Trial Outcomes & Findings for Perioperative Intravenous Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery (NCT NCT00840996)

Results Overview

The pain score as measured by verbal response scores (scale ranging from 0 to 10 with 0=no pain; 10=worst pain) every 30 minutes during post anesthesia care unit stay, then per nursing floor protocol (roughly every 4-6 hours).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

116 participants

Primary outcome timeframe

From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier).

Results posted on

2016-12-23

Participant Flow

With approval of the institutional review board at the Cleveland Clinic and written informed consent, between September 2009 to October 2011 we enrolled 116 patients to undergo elective multi-level spine surgery At Cleveland Clinic, Cleveland, Ohio, USA .

Participant milestones

Participant milestones
Measure	Lidocaine Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours	Placebo Perioperative equal volume of saline placebo IV infusion
Overall Study STARTED	58	58
Overall Study COMPLETED	57	58
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Lidocaine Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours	Placebo Perioperative equal volume of saline placebo IV infusion
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Perioperative Intravenous Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine n=57 Participants Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours	Placebo n=58 Participants Perioperative equal volume of saline placebo IV infusion	Total n=115 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 11 • n=5 Participants	54 years STANDARD_DEVIATION 11 • n=7 Participants	56 years STANDARD_DEVIATION 11 • n=5 Participants
Gender Female	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Gender Male	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants

PRIMARY outcome

Timeframe: From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier).

The pain score as measured by verbal response scores (scale ranging from 0 to 10 with 0=no pain; 10=worst pain) every 30 minutes during post anesthesia care unit stay, then per nursing floor protocol (roughly every 4-6 hours).

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants Perioperative equal volume of saline placebo IV infusion	Lidocaine n=57 Participants Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
Mean Pain Scores	5.3 verbal response scores Standard Deviation 0.13	4.4 verbal response scores Standard Deviation 0.13

PRIMARY outcome

Timeframe: through postoperative day 2 (or discharge, if earlier)

Opioid consumption during the initial 48 postoperative hours was converted to IV morphine sulfate equivalents

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants Perioperative equal volume of saline placebo IV infusion	Lidocaine n=57 Participants Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
Opioid Medication Requirement, mg in IV Morphine Equivalent	74 mg IV morphine equivalent Standard Deviation 11	55 mg IV morphine equivalent Standard Deviation 8

SECONDARY outcome

Timeframe: 30 days after surgery

The occurrence in an individual of one or more the following major complications, including pneumonia, respiratory failure, prolonged use or need for reinsertion of chest tube, cardiac arrest, arrhythmia, congestive heart failure, stroke, intravascular coagulopathy, thromboembolic disease (pulmonary embolism), injury to great vessels, delirium, monoplegia or paraplegia, upper gastrointestinal bleeding, gastrointestinal block, ureteral obstruction, syndrome of inappropriate antidiruretic hormone secretion, wound infection requiring debridement, sepsis, and readmission.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants Perioperative equal volume of saline placebo IV infusion	Lidocaine n=57 Participants Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
Number of Participants With Any Major 30-day Post Operative Complications	5 participants	2 participants

SECONDARY outcome

Timeframe: post op day one and two or till hospital discharge

Population: We only have 39 and 36 patients for comparison of PONV at day two after surgery, since the rest were discharged by that time

Postoperative Nausea and Vomiting (PONV)will be noted during day one and day two postoperative.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Perioperative equal volume of saline placebo IV infusion	Lidocaine n=39 Participants Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
Postoperative Nausea and Vomiting (PONV) Nausea	8 participants	4 participants
Postoperative Nausea and Vomiting (PONV) Vomiting	1 participants	2 participants

SECONDARY outcome

Timeframe: At discharge

Population: 3 patients in the placebo group did not have duration of hospital stay recorded.

Length of hospital stay will be recorded in days.

Outcome measures

Outcome measures
Measure	Placebo n=55 Participants Perioperative equal volume of saline placebo IV infusion	Lidocaine n=57 Participants Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
Duration of Hospitalization	3 days Interval 2.0 to 4.0	3 days Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: 30 days post operative

Population: Include the participants who finished the Acute SF 12 health survey at 30 days follow-up

Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Outcome measures
Measure	Placebo n=55 Participants Perioperative equal volume of saline placebo IV infusion	Lidocaine n=54 Participants Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
12-item Short Form Survey (SF-12) Physical Health Composite Score	33 units on a scale Interval 27.0 to 42.0	38 units on a scale Interval 31.0 to 47.0

SECONDARY outcome

Timeframe: 90 days post operative

Population: Include the participants who finished the Acute SF 12 health survey at 90 days follow-up

Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Perioperative equal volume of saline placebo IV infusion	Lidocaine n=51 Participants Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
12-item Short Form Survey (SF-12) Physical Health Composite Score	34 units on a scale Interval 28.0 to 44.0	39 units on a scale Interval 31.0 to 49.0

Adverse Events

Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Roberta Johnson

Cleveland Clinic

Phone: 216-444-9950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place