Evaluation of Spine Surgery Analgesic Pathway

Ketamine

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

Intervention / Treatment

  • Spine surgery analgesic pathway (OTHER)
    Enhanced pain management care
  • Usual Care (OTHER)
    Standard of pain management care

Condition or Disease

  • Posterior Spine Surgery

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 80 Years
    Enrollment: 299 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    SINGLE:
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jul 01, 2016
    Primary Completion: Jan 01, 2019 ACTUAL
    Completion Date: Jul 16, 2019 ACTUAL
    Study First Posted: Sep 02, 2016 ESTIMATED
    Results First Posted: Jun 01, 2020 ACTUAL
    Last Updated: Dec 15, 2020

    Sponsors / Collaborators

    Lead Sponsor: The Cleveland Clinic
    Responsible Party: N/A

    Location

    Cleveland, Ohio, USA

    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.

    Participant Groups

    • 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.

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 80
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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 Outcomes

    • 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).

    • 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.

    • 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 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.

    Other Outcomes

    • 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

    • 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.

    • 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

    • 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.

    • 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."

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

    • 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.

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

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

    More Details

    NCT Number: NCT02887404
    Other IDs: 16-012
    Study URL: https://clinicaltrials.gov/study/NCT02887404
    Last updated: Sep 29, 2023