Trial Outcomes & Findings for Evaluation of Spine Surgery Analgesic Pathway (NCT NCT02887404)

Last Updated: 2021-01-06

Results Overview

Assessment of postoperative recovery should be multidimensional including physiological parameters, functional recovery parameters, and patient-reported outcomes. Quality of postoperative recovery will be assessed by asking the patient "how have you been feeling during the past 24 hours." Using the Quality of recovery form (QoR15) to document their replies. Quality of recovery (QoR15) score of (0 to 10), where: (0) none of the time (poor) and (10) equal all of the time (excellent). There are a total of 15 questions with each score ranging from 0 to 10. The range of reported total score is 0-150 where higher scores mean better quality of recovery.

Recruitment status

COMPLETED

Study phase

Target enrollment

299 participants

Primary outcome timeframe

Three days after surgery

Results posted on

2021-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	Spine Surgery Analgesic Pathway Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Overall Study STARTED	150	149
Overall Study COMPLETED	150	149
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Spine Surgery Analgesic Pathway

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spine Surgery Analgesic Pathway n=150 Participants Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=149 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care	Total n=299 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 12 • n=93 Participants	63 years STANDARD_DEVIATION 11 • n=4 Participants	63 years STANDARD_DEVIATION 13 • n=27 Participants
Sex: Female, Male Female	69 Participants n=93 Participants	78 Participants n=4 Participants	147 Participants n=27 Participants
Sex: Female, Male Male	81 Participants n=93 Participants	71 Participants n=4 Participants	152 Participants n=27 Participants
Race/Ethnicity, Customized White	144 Participants n=93 Participants	140 Participants n=4 Participants	284 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
Race/Ethnicity, Customized Other	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
BMI	31 kg/m^2 STANDARD_DEVIATION 7 • n=93 Participants	32 kg/m^2 STANDARD_DEVIATION 7 • n=4 Participants	31 kg/m^2 STANDARD_DEVIATION 7 • n=27 Participants
Smoking	71 Participants n=93 Participants	73 Participants n=4 Participants	144 Participants n=27 Participants
History of diabetes	33 Participants n=93 Participants	25 Participants n=4 Participants	58 Participants n=27 Participants
History of chronic pain	120 Participants n=93 Participants	108 Participants n=4 Participants	228 Participants n=27 Participants
Previous opioid use	80 Participants n=93 Participants	81 Participants n=4 Participants	161 Participants n=27 Participants
High anxiety before surgery	54 Participants n=93 Participants	54 Participants n=4 Participants	108 Participants n=27 Participants
Preoperative pain score	5.3 units on a scale STANDARD_DEVIATION 2.8 • n=93 Participants	5.3 units on a scale STANDARD_DEVIATION 2.7 • n=4 Participants	5.3 units on a scale STANDARD_DEVIATION 2.8 • n=27 Participants
ASA status, No (%) I	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
ASA status, No (%) II	32 Participants n=93 Participants	21 Participants n=4 Participants	53 Participants n=27 Participants
ASA status, No (%) III	117 Participants n=93 Participants	126 Participants n=4 Participants	243 Participants n=27 Participants
Charlson comorbidity index, No(%) 0	80 Participants n=93 Participants	83 Participants n=4 Participants	163 Participants n=27 Participants
Charlson comorbidity index, No(%) 1	36 Participants n=93 Participants	34 Participants n=4 Participants	70 Participants n=27 Participants
Charlson comorbidity index, No(%) 2	21 Participants n=93 Participants	20 Participants n=4 Participants	41 Participants n=27 Participants
Charlson comorbidity index, No(%) 3	4 Participants n=93 Participants	7 Participants n=4 Participants	11 Participants n=27 Participants
Charlson comorbidity index, No(%) 4 and above	9 Participants n=93 Participants	5 Participants n=4 Participants	14 Participants n=27 Participants
No. of risk factors for uncontrolled postoperative pain 1	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
No. of risk factors for uncontrolled postoperative pain 2	40 Participants n=93 Participants	40 Participants n=4 Participants	80 Participants n=27 Participants
No. of risk factors for uncontrolled postoperative pain 3	44 Participants n=93 Participants	42 Participants n=4 Participants	86 Participants n=27 Participants
No. of risk factors for uncontrolled postoperative pain 4	32 Participants n=93 Participants	47 Participants n=4 Participants	79 Participants n=27 Participants
No. of risk factors for uncontrolled postoperative pain 5	26 Participants n=93 Participants	18 Participants n=4 Participants	44 Participants n=27 Participants
No. of risk factors for uncontrolled postoperative pain 6	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants

PRIMARY outcome

Timeframe: Three days after surgery

Population: 21 patients in the treatment group were missing and 20 patients were missing in the placebo group

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=129 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=129 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Quality of Recovery	109 units on a scale Standard Deviation 25	109 units on a scale Standard Deviation 23

SECONDARY outcome

Timeframe: up to 48 hours

Opioid consumption within the initial 48 h was converted to IV morphine equivalents using the conversions specified in Supplemental Digital Content 1 (http:// links.lww.com/ALN/C178).

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=150 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=149 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Opioid Utilization	72 mg Interval 48.0 to 113.0	75 mg Interval 50.0 to 152.0

SECONDARY outcome

Timeframe: 15-min interval after surgery until postoperative 2 days or discharge, whichever came first

Postoperative pain was evaluated with numeric rating scores (0-10) at 15-min intervals for the initial two postoperative hours or until discharge, whichever came first. A time-weighted averages pain score is equal to the sum of the portion of each time interval (as a decimal, such as 0.25h) multiplied by the levels of the pain (0-10 numeric rating scores) during the time period divided by 48h.

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=150 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=149 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Time-weighted Pain Score	4.8 units on a scale Standard Error 1.8	5.2 units on a scale Standard Error 1.9

SECONDARY outcome

Timeframe: POD1

Opioid-Related Symptom Distress Scale (ORSDS) evaluates opioid-related side effects. ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 opioid-related side effects. The mean of the 12 scores are reported with a range from 0-4 where the higher scores mean more opioid-related side effects.

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=150 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=149 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Opioid-related Side Effects Score POD1 (Postoperative Day 1)	2 score on a scale Interval 1.0 to 3.0	2 score on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: POD2

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=150 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=149 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Opioid-related Side Effects Score POD2 (Postoperative Day 2)	2 score on a scale Interval 1.0 to 3.0	2 score on a scale Interval 1.0 to 2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: POD 3 (72 hours) or discharge, whichever comes earlier

The patient satisfaction with pain management at discharge using (NRS 1-100) or on POD 3 or discharge, whichever comes earlier. The higher score means a better outcome

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=145 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=142 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Exploratory Outcome Measurement Patient Satisfaction With Pain Management at Discharge From the Hospital (Numeric Rating System 1-100)	78 units on a scale Standard Deviation 22	81 units on a scale Standard Deviation 20

OTHER_PRE_SPECIFIED outcome

Timeframe: At 1 months

Quality of postoperative recovery will be assessed by asking the patient "how have you been feeling during the past 24 hours." Using the Quality of recovery form (QoR15) to document their replies. Quality of recovery (QoR15) score of (0 to 10), where: (0) none of the time (poor) and (10) equal all of the time (excellent). There are a total of 15 questions with each score ranging from 0 to 10. The range of reported total score is 0-150 where higher scores mean better quality of recovery.

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=137 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=136 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Exploratory Outcome Measurement Quality of Recovery (QoR) Score at 1 Months	125 units on a scale Standard Deviation 22	122 units on a scale Standard Deviation 20

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 months

Using EQ-5D questionnaire for pain disability measurements, at 3 months with the flexibility of +/- 5 days using the EQ-5D questionnaire (0) no pain to (10) worst pain. EQ-5D is a standardized measure of health status developed by EuroQol GROUP

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=127 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=115 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Exploratory to Measure PDQ (Pain Disability) Using EQ-5D	7.0 units on a scale Standard Deviation 2.0	7.3 units on a scale Standard Deviation 2.1

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

It is one of several instruments used to verify the quality-adjusted life years associated with a health state. It is defined as a survey instrument for measuring economic preferences for health states based on the assessment of mobility, self-care, usual activities, pain/discomfort and anxiety/depression (5 items in total). Each dimension has 3 levels: 1=no problem, 2=moderate problem, 3=severe problem. The total scores are calculated for each subject.

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=143 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=139 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Exploratory to Measure Health-related Quality of Life Using EQ-5D	8.6 units on a scale Standard Deviation 2.0	9.1 units on a scale Standard Deviation 2.4

OTHER_PRE_SPECIFIED outcome

Timeframe: at 3 months

The exploratory outcome chronic postsurgical pain at 3 months was assessed by phone call using a numeric rating scale (0 to 10) where a score of 0 is "no pain" and a score of 10 is "pain as bad as it could be."

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=122 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=111 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Exploratory Outcome: Chronic Postsurgical Pain at 3 Months (0-10 NRS Scale)	2.6 units on a scale Standard Deviation .5	2.9 units on a scale Standard Deviation 2.9

OTHER_PRE_SPECIFIED outcome

Timeframe: from the time when patients were transferred to the Post-Anesthesia Care Unit to the time when patients were transferred out from the Post-Anesthesia Care Unit.

Postoperative-anesthesia care unit (PACU) length of stay measured how many hours the patient had spent in PACU.

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=149 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=146 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Exploratory Outcome: PACU Length of Stay (h)	3.6 hours Interval 2.6 to 5.0	3.3 hours Interval 2.6 to 4.4

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative time until discharge

Postoperative nausea and vomiting was assessed using Postoperative Nursing Progress Record (NPR) - Records nausea vomiting severity as 0=none, 1= mild, 2=moderate, 3= severe.

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=146 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=147 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU None	91 Participants	95 Participants
Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU Mild	27 Participants	30 Participants
Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU Moderate	15 Participants	12 Participants
Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU Severe	13 Participants	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative time until discharge

Postoperative length of hospital stay measured how many days the patient had spent in the hospital after surgery.

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=150 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=149 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Exploratory Outcome: Postoperative Length of Hospital Stay (Days)	3 days Interval 1.0 to 5.0	4 days Interval 1.0 to 6.0

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative until discharge

The outcome measured how many patients needed acute pain consultation after the surgery, as determined by clinical need

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=119 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=121 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Exploratory Outcome: Need for Acute Pain Consultation, as Determined by Clinical Need	16 Participants	13 Participants

POST_HOC outcome

Timeframe: 48 hours after surgery

This outcome measured how many patients used acetaminophen during the 48 hours after the surgery

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=150 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=149 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Exploratory Outcome: Number of Participants With Postoperative Acetaminophen Use	141 Participants	136 Participants

POST_HOC outcome

Timeframe: 48 hours after surgery

This outcome measured how many patients used postoperative gabapentin during the 48 hours after the surgery.

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=150 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=149 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Exploratory Outcome: the Number of Patients Who Had Postoperative Gabapentin	59 Participants	59 Participants

POST_HOC outcome

Timeframe: 48 hours after surgery

This outcome measured how many patients used postoperative tramadol during the 48 hours after the surgery.

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=150 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=149 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Exploratory Outcome: the Number of Patients Who Had Postoperative Tramadol	1 Participants	7 Participants

POST_HOC outcome

Timeframe: within 48 hours after surgery

This outcome measured how many patients used postoperative ketorolac during the 48 hours after the surgery.

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=150 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=149 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Exploratory Outcome: the Number of Patients Who Had Postoperative Ketorolac Within 48 Hours	38 Participants	38 Participants

POST_HOC outcome

Timeframe: within 48 hours after surgery

This outcome measured how many patients used postoperative suboxone during the 48 hours after the surgery.

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=150 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=149 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Exploratory Outcome: the Number of Patients Who Had Postoperative Suboxone Within 48 Hours	0 Participants	0 Participants

POST_HOC outcome

Timeframe: within 48 hours after surgery

This outcome measured how many patients used postoperative patient-controlled analgesia during the 48 hours after the surgery.

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=150 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=149 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Exploratory Outcome: the Number of Patients Who Had Postoperative PCA (Patient-controlled Analgesia) Use Within 48h	90 Participants	81 Participants

POST_HOC outcome

Timeframe: within 24 hours after the surgery

This outcome measured how many postoperative opioids (mg in morphine equivalents) patients used during the 24 hours after the surgery.

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=150 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=149 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Secondary Outcome: 24-h Opioid Consumption	47 mg Interval 26.0 to 68.0	45 mg Interval 33.0 to 81.0

POST_HOC outcome

Timeframe: within 24 hours after the surgery

Pain score is a 10 point scale score where the higher means more pain.

Outcome measures

Outcome measures
Measure	Spine Surgery Analgesic Pathway n=150 Participants Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). During surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Spine surgery analgesic pathway: Enhanced pain management care	Usual Care n=149 Participants Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg). Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake). After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed. Usual Care: Standard of pain management care
Secondary Outcome: 24h Time-weighted Average Pain Score	4.8 score on a scale Standard Deviation 1.9	5.3 score on a scale Standard Deviation 2.0

Adverse Events

Spine Surgery Analgesic Pathway

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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

Dr. Kamal Maheshwari

Cleveland Clinic Foundation

Phone: 216-4454311

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place