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

NCT ID: NCT05413902

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-05
• Study Completion Date: 2022-03-23

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.

Detailed Description

After seeking Institutional Review Board (IRB) approval, a randomized clinical trial study will be conducted with a diagnosis of Lumbar stenosis between levels of L1-S1 who underwent operative posterior spinal fusion and instrumentation (PSF) and were admitted to Hospital Universitario de Adultos, San Juan, PR. A sample size of n=50 is considered for each study arm. Three surgeons with Spine orthopedic surgery fellowship will perform all the surgical procedures. Inclusion criteria for eligible patients are lumbar stenosis with levels between L1-S1, no prior surgical treatment of spinal deformity, 30 - 85-years of age, and atraumatic pathology. The patients were considered participants after providing written informed consent. Patients were excluded if they were younger than 30 years old or older than 85 years and had a prior history of chronic opioid abuse, corrective surgery, or traumatic pathology. Patients were divided into two randomly selected groups. A random numerator generator has chosen patients' analgesic protocol, creating two groups in an aleatory manner. Group 1 received a Multimodal Analgesia (MMA) Protocol. Group 2 experienced a traditional analgesia protocol (Narcotics/Opioids). As part of the preoperative care for all patients undergoing PSF, lab work includes complete blood count, complete metabolic panel, and coagulation panel. In addition, all patients were assessed by internal medicine for clearance before surgery. Group 1 received multimodal analgesia, including Toradol 60mg IV, Acetaminophen 1,000mg PO, Orphenadrine 100mg PO, and Gabapentin 800 mg PO prior to surgery. Group 2 will not be given oral analgesia preoperatively. As part of the intraoperative care, group 1 was given: Bupivacaine 30cc, Epinephrine 1c,c, and MPF Intramuscular Inj 0.5% (30cc of Saline Solution) in paraspinal and adjacent areas before surgical incision at the time of timeout. Both study arms received routine postoperative care and were followed daily while admitted to the hospital. Patients in group 1 were treated with a postoperative pain management protocol including Gabapentin 300mg PO Q6hrs, Toradol 30mg IV Q6hrs, Methylprednisolone 125mg Q8hrs, and orphenadrine 100mg PO twice daily. Group 2 received a traditional opioid-based pain management approach with Morphine 4mg Q4hrs. Patients were asked for daily pain levels using 1-10, and IV morphine use as needed will be measured daily. Data Collection will occur intra-hospital during the perioperative period. The study variables retrieved included sociodemographic Information, surgery Duration, surgical approach, levels of instrumentation, type of instrumentation, Surgery blood loss, Complications, Discharge Time, Length of Stay, Comorbidities, and Visual Analog Scale (VAS) for pain score preoperative and postoperative at 12, 24, and 48 hours.

Conditions

Pain Management; Posterior Spinal Fusion

Study Design

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

Study Groups

MMA Protocol Group

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

Group Type: EXPERIMENTAL

Toradol

Intervention Type: DRUG

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

Orphenadrine

Intervention Type: DRUG

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

Gabapentin

Intervention Type: DRUG

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

Acetaminophen

Intervention Type: DRUG

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

Bupivacaine

Intervention Type: DRUG

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

Epinephrine

Intervention Type: DRUG

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

Xylocaine Injectable Solution

Intervention Type: DRUG

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

Methylprednisolone

Intervention Type: DRUG

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

Control (opioids) Group

Postoperative Medication

1-Morphine 4mg Q4hrs

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

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

Interventions

Toradol

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

Intervention Type: DRUG

Morphine

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

Intervention Type: DRUG

Orphenadrine

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

Intervention Type: DRUG

Gabapentin

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

Intervention Type: DRUG

Acetaminophen

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

Intervention Type: DRUG

Bupivacaine

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

Intervention Type: DRUG

Epinephrine

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

Intervention Type: 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.

Intervention Type: DRUG

Methylprednisolone

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

Intervention Type: DRUG

Other Intervention Names

Multimodal Analgesia Protocol; Narcotics; Opioids; Multimodal Analgesia Protocol; Multimodal Analgesia Protocol; Multimodal Analgesia Protocol; Multimodal Analgesia Protocol; Multimodal Analgesia Protocol; Multimodal Analgesia Protocol; Multimodal Analgesia Protocol

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Puerto Rico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José Montañez, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Puerto Rico Medical Center - University District Hospital

San Juan, PR, Puerto Rico

Countries

Puerto Rico

References

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.

Reference Type: DERIVED

PMID: 37192425 (View on PubMed)

Other Identifiers

A9630120

Identifier Type: -

Identifier Source: org_study_id