Evaluation of Spine Surgery Analgesic Pathway

NCT02887404 | Completed Results

• 1 other identifier: 16-012
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 1

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

Conditions

Posterior Spine Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Opioid Utilization

  up to 48 hours

• Time-weighted Pain Score

  15-min interval after surgery until postoperative 2 days or discharge, whichever came first

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

  POD1

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

  POD2

Other Outcomes (9)

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

  POD 3 (72 hours) or discharge, whichever comes earlier

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

  At 1 months

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

  Up to 3 months

Study Arms (2)

Spine surgery analgesic pathway

EXPERIMENTAL

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.

Other: Spine surgery analgesic pathway

Usual care

ACTIVE COMPARATOR

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.

Other: Usual Care

Interventions

Spine surgery analgesic pathway OTHER

Enhanced pain management care

Spine surgery analgesic pathway

Usual Care OTHER

Standard of pain management care

Usual care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Results Point of Contact

• Title: Dr. Kamal Maheshwari
• Organization: Cleveland Clinic Foundation

maheshk@ccf.org

216-4454311

Study Officials

• Daniel I Sessler, M.D.

  Department Chair

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: September 2, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: July 16, 2019
• Last Updated: January 6, 2021
• Results First Posted: June 1, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)