Multi-Modal Anesthesia Protocol in Pain Management of Patients Undergoing Posterior Lumbar Spinal Fusion Surgery
Condition: Pain Management; Posterior Spinal Fusion
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Toradol; Morphine; Orphenadrine; Gabapentin; Acetaminophen; Bupivacaine; Epinephrine; Xylocaine Injectable Solution; Methylprednisolone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.; Provide the standard postoperative morphine dose for pain management as part of the traditional opioid-based pain management regime.; Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.; Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.; Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.; Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.; Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.; Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.; Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.
Other intervention name(s): 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
Intervention MeSH terms: Acetaminophen; Methylprednisolone; Ketorolac Tromethamine; Lidocaine; Epinephrine; Morphine; Narcotics; Gabapentin; Orphenadrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care