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

Pain Management Clinical Trial

Official title:

Efficiency of Multi-Modal Anesthesia (MMA) Protocol in Pain Control and Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05413902
• Other study ID #: A9630120
• Status: Completed
• Phase: Phase 4
• Start date: April 5, 2021
• Est. completion date: March 23, 2022

Study information

• Verified date: June 2022
• Source: University of Puerto Rico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 23, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain Management
• Posterior Spinal Fusion

Intervention

Drug:
• Toradol
Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.
• Morphine
Provide the standard postoperative morphine dose for pain management as part of the traditional opioid-based pain management regime.
• Orphenadrine
Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.
• Gabapentin
Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.
• Acetaminophen
Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.
• Bupivacaine
Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.
• Epinephrine
Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.
• Xylocaine Injectable Solution
Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.
• Methylprednisolone
Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.

Locations

Country	Name	City	State
Puerto Rico	Puerto Rico Medical Center - University District Hospital	San Juan

Sponsors (1)

Lead Sponsor	Collaborator
University of Puerto Rico

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Days in Hospital	The number of days in hospital represents the duration of postoperative hospital care from the surgery to discharge.	At discharge, at day 3 on average.
Secondary	Rate of Surgical Complications	The rate of surgical complications will represent any situation that deviates from the adequate/optimal postoperative history or care until discharge.	At discharge, at day 3 on average