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Completed

NCT Number: NCT02887404

Evaluation of Spine Surgery Analgesic Pathway

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

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Key information

Conditions

Posterior Spine Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spine surgery analgesic pathway

Other

Enhanced pain management care

Usual Care

Other

Standard of pain management care

Primary outcomes

  1. Quality of Recovery

    Time frame: 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 outcomes

  1. Opioid Utilization

    Time frame: 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).

  2. Time-weighted Pain Score

    Time frame: 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.

  3. Opioid-related Side Effects Score POD1 (Postoperative Day 1)

    Time frame: 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.

  4. Opioid-related Side Effects Score POD2 (Postoperative Day 2)

    Time frame: 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.

Other outcomes

  1. Exploratory Outcome Measurement Patient Satisfaction With Pain Management at Discharge From the Hospital (Numeric Rating System 1-100)

    Time frame: 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

  2. Exploratory Outcome Measurement Quality of Recovery (QoR) Score at 1 Months

    Time frame: 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.

  3. Exploratory to Measure PDQ (Pain Disability) Using EQ-5D

    Time frame: 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

  4. Exploratory to Measure Health-related Quality of Life Using EQ-5D

    Time frame: 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.

  5. Exploratory Outcome: Chronic Postsurgical Pain at 3 Months (0-10 NRS Scale)

    Time frame: 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."

  6. Exploratory Outcome: PACU Length of Stay (h)

    Time frame: 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.

  7. Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU

    Time frame: 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.

  8. Exploratory Outcome: Postoperative Length of Hospital Stay (Days)

    Time frame: postoperative time until discharge

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

  9. Exploratory Outcome: Need for Acute Pain Consultation, as Determined by Clinical Need

    Time frame: postoperative until discharge

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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Evaluation of Spine Surgery Analgesic Pathway: A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 2, 2016
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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