Evaluation of Spine Surgery Analgesic Pathway

NCT ID: NCT02887404

Last Updated: 2021-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 299 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-07-16

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.

Conditions

Posterior Spine Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Spine surgery analgesic pathway

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.

Group Type: EXPERIMENTAL

Spine surgery analgesic pathway

Intervention Type: OTHER

Enhanced pain management care

Usual care

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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Standard of pain management care

Interventions

Spine surgery analgesic pathway

Enhanced pain management care

Intervention Type: OTHER

Usual Care

Standard of pain management care

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Kamal Maheshwari, MD MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel I Sessler, M.D.

Role: STUDY_CHAIR

Department Chair

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-012

Identifier Type: -

Identifier Source: org_study_id