Pain Control After Lumbar Spine Fusion | NCT06484192

Studies
Pain Control After Lumbar Spine Fusion

NCT06484192

Sponsor

Rothman Institute Orthopaedics

Status

Unknown status

Last Update Posted

Jul 3, 2024Actual

Enrollment

428Estimated

Phase

Phase 4

Conditions

Spine Fusion
NSAID (Non-Steroidal Anti-Inflammatory Drug)
Postoperative Pain

Interventions

Naproxen 500 Mg
Ketorolac
OxyCODONE 5 mg Oral Tablet
Metaxalone 800 MG

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 28, 2024Estimated

Primary Completion Date

Jun 30, 2025Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Jun 26, 2024

First Submission Date that Met QC Criteria

Jun 26, 2024

First Posted Date

Jul 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2024

Last Update Posted Date

Jul 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this randomized controlled trial is to determine if patients who receive non-steroidal anti-inflammatory medications (NSAIDs) following elective lumbar spinal fusion have increased rates of symptomatic nonunion requiring revision spinal surgery at two-years follow-up, compared to those who do not receive NSAIDs.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

428Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: NSAID Group	Active Comparator	Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery	Drug: Naproxen 500 Mg Drug: Ketorolac Drug: OxyCODONE 5 mg Oral Tablet Drug: Metaxalone 800 MG
Group 2: Control Group	Active Comparator	Participants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion surgery	Drug: OxyCODONE 5 mg Oral Tablet Drug: Metaxalone 800 MG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Naproxen 500 Mg	Drug	participants will receive Naproxen (500 mg) to take for 7 days after surgery as needed	Group 1: NSAID Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fusion failure	Failure of fusion surgery will be measured by the rate of revisions as demonstrated by participant x-rays	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥18 years of age, ≥1-level planned lumbar spinal fusion
Capacity to enroll
English speaking

Exclusion Criteria:

Chronic kidney disease (preoperative creatinine ≥1.4)
History of gastrointestinal bleed or peptic ulcer disease
History of spinal fusion nonunion
Non-steroidal anti-inflammatory drug allergy
Previously diagnosed coagulopathy
Preoperative thrombocytopenia (platelets <100,000)
Connective tissue disease
Operative indication due to infection, neoplasm, or trauma
Currently pregnant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rothman Orthopaedic Institute		Philadelphia	Pennsylvania	19107	United States

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009288	Naproxen
D020910	Ketorolac
D010098	Oxycodone
D013607	Tablets
C011301	metaxalone

Ancestor Terms

ID	Term
D009280	Naphthaleneacetic Acids
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided