NCT03820193

Brief Summary

This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of arthroscopic meniscus surgery: a treatment group given a non-opioid pain control regimen, and a standard of care control group given standard opioid pain control regimen

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

January 25, 2019

Last Update Submit

November 30, 2023

Conditions

Meniscus DisorderNarcotic Use

Outcome Measures

Primary Outcomes (2)

  • Pain Levels

    Patients record pain levels every 3 hours using Visual analog scales for 10 days post-operatively. Average daily pain was calculated for each patient. Higher values portend worse control.

    10 days post-operatively

  • Patient Reported Outcome Measurement Information System

    Patient Reported Outcome Measurement Information System - Pain Interference (PROMIS PI) scores collected nightly until study completion. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference.

    10 days post-operatively

Study Arms (2)

Post-Operative Non Opioid Pain Protocol

EXPERIMENTAL

Patients will be administered a post-operative non-opioid pain protocol consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam

Drug: CelecoxibDrug: KetorolacDrug: GabapentinDrug: AcetaminophenDrug: Diazepam

Post-Operative Traditional Pain Protocol

ACTIVE COMPARATOR

Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen

Drug: Hydrocodon/Acetaminophen

Interventions

CelecoxibDRUG

Post-Operative Non Opioid Pain Protocol

Also known as: Celebrex
Post-Operative Non Opioid Pain Protocol
Hydrocodon/AcetaminophenDRUG

Traditionally used narcotic pain control

Also known as: Norco
Post-Operative Traditional Pain Protocol
KetorolacDRUG

Post-Operative Non Opioid Pain Protocol

Also known as: Toradol
Post-Operative Non Opioid Pain Protocol
GabapentinDRUG

Post-Operative Non Opioid Pain Protocol

Also known as: Neurontin
Post-Operative Non Opioid Pain Protocol
AcetaminophenDRUG

Post-Operative Non Opioid Pain Protocol

Also known as: Tylenol
Post-Operative Non Opioid Pain Protocol
DiazepamDRUG

Post-Operative Non Opioid Pain Protocol

Also known as: Valium
Post-Operative Non Opioid Pain Protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients over age 18 scheduled for arthroscopic meniscus repair or partial menisectomy

You may not qualify if:

  • Patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Interventions

CelecoxibHydrocodoneAcetaminophenoxycodone-acetaminophenKetorolacKetorolac TromethamineGabapentinDiazepam

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAcetanilidesAnilidesAniline CompoundsAminesIndomethacinIndolesHeterocyclic Compounds, 2-Ringgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicAmino AcidsAmino Acids, Peptides, and ProteinsBenzodiazepinonesBenzodiazepinesBenzazepines

Study Officials

  • Toufic R Jildeh, MD

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Surgeon

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 29, 2019

Study Start

January 22, 2019

Primary Completion

June 20, 2020

Study Completion

January 20, 2021

Last Updated

December 5, 2023

Record last verified: 2023-11

Locations

US(1)