Multi-Modal Anesthesia Protocol in Pain Management of Patients Undergoing Posterior Lumbar Spinal Fusion Surgery

NCT05413902 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: A9630120
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study consisted of a randomized controlled trial designed to evaluate a Multimodal Analgesia (MMA) Protocol on patients undergoing Posterior Spinal Fusion. The purpose is to describe the narcotic requirements and usage during the perioperative period of posterior spinal fusion and instrumentation surgery with the implementation of multimodal anesthesia protocol. The study will consist of two parallel arms, with Group 1 receiving our MMA protocol and Group 2 receiving a traditional opioid-based regime. The primary outcome of this study will be the reported Visual Analog Scale (VAS) for pain at 12, 24, and 48 hours after surgery. We considered that our findings could contribute to the fight against the opioid crisis proving alternatives to opioids as feasible alternatives for pain management even in significant surgery, as is posterior spinal fusion with instrumentation.

Conditions

Pain Management; Posterior Spinal Fusion

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analog Scale reported pain score

  The numeric rating scale is an 11-point scale scored from 0-10 to describe the intensity of pain. Patients verbally select the numeric value that is more consistent with the pain experienced. The value 0 consist of no pain and 10 consist the worst pain experienced in life. Therefore, the higher the value the worst the pain is considered.

  At 12 hours, at 24 hours and at 48 hours

Secondary Outcomes (2)

• Number of Days in Hospital

  At discharge, at day 3 on average.

• Rate of Surgical Complications

  At discharge, at day 3 on average

Study Arms (2)

MMA Protocol Group

EXPERIMENTAL

Preoperative Medications 1. Orphenadrine 100mg PO once preop 2. Gabapentin 800mg PO once preop 3. Toradol 60mg IV once preop 4. Acetaminophen 1,000mg PO once preop Intraoperative Paraspinal Infusion 1. Bupivacaine 30cc 2. Epinephrine 1cc 3. Xylocaine-MPF Intramuscular Inj 0.5% (30cc of Saline Solution) Postoperative Medications 1. Orphenadrine 100mg PO BID 2. Gabapentin 300mg PO Q6 3. Toradol 30mg IV Q6hrs\* 4. Methylprednisolone 125mg Q8hrs

Drug: Toradol; Drug: Orphenadrine; Drug: Gabapentin; Drug: Acetaminophen; Drug: Bupivacaine; Drug: Epinephrine; Drug: Xylocaine Injectable Solution; Drug: Methylprednisolone

Control (opioids) Group

ACTIVE COMPARATOR

Postoperative Medication 1-Morphine 4mg Q4hrs

Drug: Morphine

Interventions

Toradol DRUG

Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.

Also known as: Multimodal Analgesia Protocol

MMA Protocol Group

Morphine DRUG

Provide the standard postoperative morphine dose for pain management as part of the traditional opioid-based pain management regime.

Also known as: Narcotics, Opioids

Control (opioids) Group

Orphenadrine DRUG

Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.

Also known as: Multimodal Analgesia Protocol

MMA Protocol Group

Gabapentin DRUG

Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.

Also known as: Multimodal Analgesia Protocol

MMA Protocol Group

Acetaminophen DRUG

Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.

Also known as: Multimodal Analgesia Protocol

MMA Protocol Group

Bupivacaine DRUG

Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.

Also known as: Multimodal Analgesia Protocol

MMA Protocol Group

Epinephrine DRUG

Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.

Also known as: Multimodal Analgesia Protocol

MMA Protocol Group

Xylocaine Injectable Solution DRUG

Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.

Also known as: Multimodal Analgesia Protocol

MMA Protocol Group

Methylprednisolone DRUG

Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.

Also known as: Multimodal Analgesia Protocol

MMA Protocol Group

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• lumbar stenosis affecting L1-S1
• Requiring Posterior Spinal Fusion Surgery
• Age 30-85 years

You may not qualify if:

• younger than 30 years old or older than 85 years
• Chronic Renal Disease
• Hypersensitivity to any medication
• history of chronic opioid abuse.

Sponsors & Collaborators

• University of Puerto Rico: lead

Study Sites (1)

Puerto Rico Medical Center - University District Hospital

San Juan, PR, Puerto Rico

Location

Related Publications (1)

• Ramirez-Gonzalez M, Torres-Lugo NJ, Deliz-Jimenez D, Echegaray-Casalduc G, Ramirez N, Colon-Rodriguez E, Carro-Rivera J, De La Cruz A, Claudio-Roman Y, Massanet-Volrath J, Escobar-Medina E, Montanez-Huertas J. Efficacy of an Opioid-Sparing Perioperative Multimodal Analgesia Protocol on Posterior Lumbar Fusion in a Hispanic Population: A Randomized Controlled Trial. J Am Acad Orthop Surg. 2023 Sep 1;31(17):931-937. doi: 10.5435/JAAOS-D-22-00878. Epub 2023 May 15.

  PMID: 37192425 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Ketorolac Tromethamine; Morphine; Narcotics; Analgesics, Opioid; Orphenadrine; Gabapentin; Acetaminophen; Bupivacaine; Epinephrine; Methylprednisolone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Acetanilides; Anilides; Amides; Aniline Compounds; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• José Montañez, MD

  Department of Orthopaedic Surgery, University of Puerto Rico, Medical Sciences Campus, San Juan, PR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: June 10, 2022
• Study Start: April 5, 2021
• Primary Completion: January 28, 2022
• Study Completion: March 23, 2022
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1)