Pain ManagementPhase 4NCT05413902
Multi-Modal Anesthesia Protocol in Pain Management of Patients Undergoing Posterior Lumbar Spinal Fusion Surgery
A Phase 4 study testing Toradol, Morphine and Orphenadrine in people with Pain Management and Posterior Spinal Fusion, run by University of Puerto Rico at 1 site in Puerto Rico.
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… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Pain Management, Posterior Spinal Fusion
- What is being tested?
- Toradol, Morphine and Orphenadrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 5 Apr 2021to 23 Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lumbar stenosis affecting L1-S1
- Requiring Posterior Spinal Fusion Surgery
- Age 30-85 years
Who cannot join
- younger than 30 years old or older than 85 years
- Chronic Renal Disease
- Hypersensitivity to any medication
- history of chronic opioid abuse.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
Puerto Rico Medical Center - University District Hospital
San Juan, PR
About this study
Official title: Efficiency of Multi-Modal Anesthesia (MMA) Protocol in Pain Control and Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion Surgery
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.
Read the 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
- Being tested
- Toradol, Morphine, Orphenadrine, Gabapentin, Acetaminophen
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToradolDrug
Also called Multimodal Analgesia Protocol
Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.
MorphineDrug
Also called Narcotics, Opioids
Provide the standard postoperative morphine dose for pain management as part of the traditional opioid-based pain management regime.
OrphenadrineDrug
Also called Multimodal Analgesia Protocol
Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.
GabapentinDrug
Also called Multimodal Analgesia Protocol
Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.
AcetaminophenDrug
Also called Multimodal Analgesia Protocol
Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.
BupivacaineDrug
Also called Multimodal Analgesia Protocol
Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.
EpinephrineDrug
Also called Multimodal Analgesia Protocol
Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.
Xylocaine Injectable SolutionDrug
Also called Multimodal Analgesia Protocol
Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.
Also called Multimodal Analgesia Protocol
Provide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 hours, at 24 hours and at 48 hours
Secondary outcomes (2)
Number of Days in Hospital
The number of days in hospital represents the duration of postoperative hospital care from the surgery to discharge.
Measured: At discharge, at day 3 on average.
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.
Measured: At discharge, at day 3 on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start5 Apr 2021
- Primary completion28 Jan 2022
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Montañez, MD, Principal investigator, Department of Orthopaedic Surgery, University of Puerto Rico, Medical Sciences Campus, San Juan, PR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413902
- Sponsor's protocol ID
- A9630120
- Status last verified
- Jun 2022
- First submitted
- 5 May 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers. However, data could be shared upon individual researchers' reasonable request.
Publications
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.
PubMed 37192425
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Multi-Modal Anesthesia (MMA) Protocol in Pain Control and Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion Surgery
- ClinicalTrials.gov ID
- NCT05413902
- Acronym / sponsor ID
- A9630120
- Conditions
- Pain Management, Posterior Spinal Fusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMA Protocol Group | Experimental | Drug: Toradol, Drug: Orphenadrine, Drug: Gabapentin, Drug: Acetaminophen, Drug: Bupivacaine, Drug: Epinephrine, Drug: Xylocaine Injectable Solution, Drug: MethylprednisolonePreoperative 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 |
| Control (opioids) Group | Active comparator | Drug: MorphinePostoperative Medication 1-Morphine 4mg Q4hrs |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- lumbar stenosis affecting L1-S1
- Requiring Posterior Spinal Fusion Surgery
- Age 30-85 years
Key exclusion criteria (4 listed)
- younger than 30 years old or older than 85 years
- Chronic Renal Disease
- Hypersensitivity to any medication
- history of chronic opioid abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ToradolAlso: Multimodal Analgesia ProtocolProvide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description. | Drug | MMA Protocol Group |
| MorphineAlso: Narcotics, OpioidsProvide the standard postoperative morphine dose for pain management as part of the traditional opioid-based pain management regime. | Drug | Control (opioids) Group |
| OrphenadrineAlso: Multimodal Analgesia ProtocolProvide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description. | Drug | MMA Protocol Group |
| GabapentinAlso: Multimodal Analgesia ProtocolProvide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description. | Drug | MMA Protocol Group |
| AcetaminophenAlso: Multimodal Analgesia ProtocolProvide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description. | Drug | MMA Protocol Group |
| BupivacaineAlso: Multimodal Analgesia ProtocolProvide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description. | Drug | MMA Protocol Group |
| EpinephrineAlso: Multimodal Analgesia ProtocolProvide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description. | Drug | MMA Protocol Group |
| Xylocaine Injectable SolutionAlso: Multimodal Analgesia ProtocolProvide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description. | Drug | MMA Protocol Group |
| MethylprednisoloneAlso: Multimodal Analgesia ProtocolProvide this drug as part of a multimodal pharmacologic regimen for pain management including multiple drugs mentioned in the group description. | Drug | MMA Protocol Group |
Primary outcome
Change in Visual Analog Scale reported pain score
Time frame: At 12 hours, at 24 hours and at 48 hours
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.
2 secondary outcomes
Number of Days in Hospital
Time frame: At discharge, at day 3 on average.
Rate of Surgical Complications
Time frame: At discharge, at day 3 on average
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Derived from this study: PubMed 37192425Ramirez-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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers. However, data could be shared upon individual researchers' reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Montañez, MD principal investigator
Department of Orthopaedic Surgery, University of Puerto Rico, Medical Sciences Campus, San Juan, PR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Toradol, Morphine and Orphenadrine in people with Pain Management and Posterior Spinal Fusion, run by University of Puerto Rico at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale reported pain score (time frame: At 12 hours, at 24 hours and at 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05413902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.