Clinical trial NCT02887404: Evaluation of Spine Surgery Analgesic Pathway
Official title: Evaluation of Spine Surgery Analgesic Pathway: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Spine Surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quality of Recovery
timeFrame: Three days after surgery
Secondary outcomes:
measure: Opioid Utilization
timeFrame: up to 48 hours
measure: Time-weighted Pain Score
timeFrame: 15-min interval after surgery until postoperative 2 days or discharge, whichever came first
measure: Opioid-related Side Effects Score POD1 (Postoperative Day 1)
timeFrame: POD1
measure: Opioid-related Side Effects Score POD2 (Postoperative Day 2)
timeFrame: POD2
Other outcomes:
measure: Exploratory Outcome Measurement Patient Satisfaction With Pain Management at Discharge From the Hospital (Numeric Rating System 1-100)
timeFrame: POD 3 (72 hours) or discharge, whichever comes earlier
measure: Exploratory Outcome Measurement Quality of Recovery (QoR) Score at 1 Months
timeFrame: At 1 months
measure: Exploratory to Measure PDQ (Pain Disability) Using EQ-5D
timeFrame: Up to 3 months
measure: Exploratory to Measure Health-related Quality of Life Using EQ-5D
timeFrame: baseline
measure: Exploratory Outcome: Chronic Postsurgical Pain at 3 Months (0-10 NRS Scale)
timeFrame: at 3 months
measure: Exploratory Outcome: PACU Length of Stay (h)
timeFrame: 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.
measure: Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU
timeFrame: postoperative time until discharge
measure: Exploratory Outcome: Postoperative Length of Hospital Stay (Days)
timeFrame: postoperative time until discharge
measure: Exploratory Outcome: Need for Acute Pain Consultation, as Determined by Clinical Need
timeFrame: postoperative until discharge
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Department Chair
name: Daniel I Sessler, M.D.
role: STUDY_CHAIR
References: