Evaluation of Spine Surgery Analgesic Pathway

Posterior Spine Surgery Clinical Trial

Official title:

Evaluation of Spine Surgery Analgesic Pathway: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02887404
• Other study ID #: 16-012
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 16, 2019

Study information

• Verified date: December 2020
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: July 16, 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Posterior Spine Surgery

Intervention

Other:
• Spine surgery analgesic pathway
Enhanced pain management care
• Usual Care
Standard of pain management care

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Outcome Measurement Patient Satisfaction With Pain Management at Discharge From the Hospital (Numeric Rating System 1-100)	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	POD 3 (72 hours) or discharge, whichever comes earlier
Other	Exploratory Outcome Measurement Quality of Recovery (QoR) Score 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.	At 1 months
Other	Exploratory to Measure PDQ (Pain Disability) Using EQ-5D	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	Up to 3 months
Other	Exploratory to Measure Health-related Quality of Life Using EQ-5D	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.	baseline
Other	Exploratory Outcome: Chronic Postsurgical Pain at 3 Months (0-10 NRS Scale)	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."	at 3 months
Other	Exploratory Outcome: PACU Length of Stay (h)	Postoperative-anesthesia care unit (PACU) length of stay measured how many hours the patient had spent in PACU.	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.
Other	Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting 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 time until discharge
Other	Exploratory Outcome: Postoperative Length of Hospital Stay (Days)	Postoperative length of hospital stay measured how many days the patient had spent in the hospital after surgery.	postoperative time until discharge
Other	Exploratory Outcome: Need for Acute Pain Consultation, as Determined by Clinical Need	The outcome measured how many patients needed acute pain consultation after the surgery, as determined by clinical need	postoperative until discharge
Primary	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	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
Secondary	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
Secondary	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
Secondary	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