Evaluation of Spine Surgery Analgesic Pathway

Study Overview
=================
Brief Summary
-----------------
Investigators plan to study the role of spine surgery analgesic pathways - for procedures with high risk of postoperative pain - in improving the quality of recovery

Detailed Description
-----------------
This is a randomized controlled trial comparing spine surgery analgesic pathway with usual care in improving postoperative quality of recovery and pain management in spine surgery patients. At the time of surgery office visit or at the time of preoperative assessment by anesthesia care team, risk factor for suboptimal pain management will be identified and documented. Patients will be assessed at the time for surgical office visit for their risk for severe post-operative pain. Patients with 2 or more risk factors will be classified as high-risk for severe postoperative pain and the patients with less than 2 factors as low risk. After obtaining informed consent spine surgery patients will be randomized 1:1 in one of the 2 study groups on the day of the surgery: Usual care group A Care pathway group B If the participant is randomized to the spine surgery analgesic pathway group the participant will be evaluated by the Acute Pain Management Service (APMS) before the surgery for their specific pain management needs. The participant will also get some additional medication for pain in preoperative and intraoperative period. Before surgery the participant will receive Acetaminophen and Gabapentin pills. During the surgery, once the participant is asleep the participant will receive an infusion of ketamine and lidocaine through the participant venous line. After the surgery the participant will receive pain medications as per current standard protocol including acetaminophen and gabapentin. Pain management team specialist will follow for pain control after a surgery as needed. If the participant is randomized to the usual care group the participant will be given placebo preoperatively; the rest of the time pain medication will be provided in a routine manner as per the anesthesia care team and the surgical team. Pain management team specialist will follow for pain control after a surgery as needed. The primary outcome will be assessed on post-operative day 3: The participants will complete a short survey about quality of recovery.

Official Title
-----------------
Evaluation of Spine Surgery Analgesic Pathway: A Randomized Controlled Trial

Conditions
-----------------
Posterior Spine Surgery

Intervention / Treatment
-----------------
* Other: Spine surgery analgesic pathway
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 80 years old at time of surgery - Adult patients differ from pediatric patients in that adult spines are stiffer than pediatric patients. Posterior spine surgery Surgery performed at Cleveland Clinic main campus Exclusion Criteria: Allergy or hypersensitivity to lidocaine, ketamine, acetaminophen, gabapentin Current or recent drug abuse (within past 6 months) Pregnancy Immune system disease such as HIV, AIDS Undergoing immunosuppressive treatment Recent history of sepsis Contraindications to lidocaine such as heart block and hepatic insufficiency Heart failure with ejection fraction less than 30% Liver dysfunction manifested with increased liver enzymes to double the normal and INR of 2 or higher

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spine surgery analgesic pathway<br>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. | Other: Spine surgery analgesic pathway<br>* Enhanced pain management care<br>|
| Active Comparator: Usual care<br>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. | Other: Usual Care<br>* Standard of pain management care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery | 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. | Three days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Utilization | 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). | up to 48 hours | 
| Time-weighted Pain Score | 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. | 15-min interval after surgery until postoperative 2 days or discharge, whichever came first | 
| Opioid-related Side Effects Score POD1 (Postoperative Day 1) | 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. | POD1 | 
| Opioid-related Side Effects Score POD2 (Postoperative Day 2) | 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. | POD2 |