Evaluation of Spine Surgery Analgesic Pathway

Not Applicable

Completed

Conditions: Posterior Spine Surgery

Interventions: Other: Usual Care
Other: Spine surgery analgesic pathway

Registration Number: NCT02887404

Lead Sponsor: The Cleveland Clinic

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:

1. "Usual care" group A

2. "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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 299

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual 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.
Spine surgery analgesic pathway	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 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.

Primary Outcome Measures

Name	Time	Method
Quality of Recovery	Three days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Opioid-related Side Effects Score POD1 (Postoperative Day 1)	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.
Opioid-related Side Effects Score POD2 (Postoperative Day 2)	POD2	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.
Opioid Utilization	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).
Time-weighted Pain Score	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.