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Dronabinol for Post-operative Pain After Lumbar Fusion

NCT04346407 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-02-12

No results posted yet for this study

Summary

Impact of 2.5mg of oral Dronabinol daily versus placebo on post-operative opioid consumption on patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion

Conditions

  • Post-operative Pain

Interventions

DRUG

Dronabinol 2.5mg Cap

2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery

DRUG

Placebo

Placebo capsule daily starting with pre-op cocktail and continued twice daily for three days after surgery

Sponsors & Collaborators

  • Jeffrey L Gum MD

    lead OTHER

Principal Investigators

  • Jeffrey L Gum, MD · Norton Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-09-01
Completion
2023-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04346407 on ClinicalTrials.gov