Multimodal Pharmacological Management for Slipped Disc

UMASS Memorial Medical Center, Worcester, MA
Slipped Disc+2 More ConditionsMultimodal Pharmacological Management - Drug
Eligibility
40 - 80
All Sexes

Study Summary

This trial will compare two local anesthetic blocks in different locations for postoperative pain control after lumbar spinal fusion, to see if it reduces opioid use.

Eligible Conditions
  • Slipped Disc
  • Pain
  • Opioid Use Disorder

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

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Vitamin D
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Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 48ours

2 weeks
Discharge Opioid Use
48 hours
Opioid Consumption
48ours
Pain Scale
Up to 1 week
Side Effects

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Vitamin D
3
Paravertebral Block
3
Infused analgesic

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

3 Treatment Groups

Group 1 Standard of Care
1 of 3
Group 2 Standard of Care + Quadratus Lumborum Block II
1 of 3
Group 2 Standard of Care + Quadratus Lumborum Block III
1 of 3

Active Control

Experimental Treatment

30 Total Participants · 3 Treatment Groups

Primary Treatment: Multimodal Pharmacological Management · No Placebo Group · Phase 3

Group 2 Standard of Care + Quadratus Lumborum Block IIExperimental Group · 2 Interventions: Multimodal Pharmacological Management, Ropivacaine injection Location 1 · Intervention Types: Drug, Drug
Group 2 Standard of Care + Quadratus Lumborum Block IIIExperimental Group · 2 Interventions: Multimodal Pharmacological Management, Ropivacaine injection Location 2 · Intervention Types: Drug, Drug
Group 1 Standard of Care
Drug
ActiveComparator Group · 1 Intervention: Multimodal Pharmacological Management · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 48ours

Who is running the clinical trial?

Eman NadaLead Sponsor
Eman Nada, MDPrincipal Investigator - University of Massachusetts, Worcester
UMass Memorial Medical Center-University Campus

Eligibility Criteria

Age 40 - 80 · All Participants · 2 Total Inclusion Criteria

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References

Frequently Asked Questions

Is this clinical trial only available to patients who are under 30 years old?

"In order to be included in this particular trial, patients must be between 40 and 80 years old. Out of the 838 total clinical trials, this is one of the 133 that focuses on a younger demographic and one of the 705 that focuses on an older demographic." - Anonymous Online Contributor

Unverified Answer

Are we still welcoming people who want to participate in this research?

"That is correct, the listing on clinicaltrials.gov does show that the research team is actively looking for participants. The trial was first advertised on December first 2020 and was most recently updated on March 18th 2021. They are currently trying to enrol 30 individuals at a single site." - Anonymous Online Contributor

Unverified Answer

What does Multimodal Pharmacological Management usually address?

"Multimodal Pharmacological Management is a standard course of treatment for cervical syndrome. It is also effective in treating conditions such as minor burns, labour, and transplantation." - Anonymous Online Contributor

Unverified Answer

Are there other examples where doctors have used multiple drugs to manage a condition?

"202 ongoing studies for Multimodal Pharmacological Management exist as of now, with 49 in Phase 3. Most clinical trials for this topic are situated in Duarte, CA, but there are 1196 locations running similar trials." - Anonymous Online Contributor

Unverified Answer

Has the FDA acknowledged the benefits of Multimodal Pharmacological Management?

"The safety of Multimodal Pharmacological Management has been well-documented in Phase 3 trials, leading our team to rate it a 3 on our safety scale." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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