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

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

Interventions

DRUG

Toradol

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

DRUG

Morphine

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

DRUG

Orphenadrine

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

DRUG

Gabapentin

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

DRUG

Acetaminophen

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

DRUG

Bupivacaine

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

DRUG

Epinephrine

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

DRUG

Xylocaine Injectable Solution

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

DRUG

Methylprednisolone

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

Sponsors & Collaborators

• University of Puerto Rico

  lead OTHER

Principal Investigators

• José Montañez, MD · Department of Orthopaedic Surgery, University of Puerto Rico, Medical Sciences Campus, San Juan, PR

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-05

Primary Completion

2022-01-28

Completion

2022-03-23

FDA Drug

Yes

Countries

• Puerto Rico

Study Locations