CBD for Pain Reduction and Opioid Use After Ankle and Tibia Fracture ORIF

NCT04768478 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 21-00069
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of administering CBD to control post-operative pain in patients undergoing ankle fracture open reduction and internal fixation, tibial plafond (pilon) open reduction and internal fixation, tibial shaft repair (open reduction internal fixation or intramedullary nail fixation), or tibial plateau open reduction and internal fixation. Secondly, the purpose is to evaluate the effectiveness of CBD in comparison with opioid therapy for post-operative pain.

Conditions

Ankle Fractures; Tibia Fracture

Keywords

Cannabidiol

Outcome Measures

Primary Outcomes (6)

• Score on Pain Visual Analog Scale (VAS)

  Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; total range = 0-10; 0 = no pain, 10 = worst pain imaginable)

  Day 2 Post-Surgery

• Score on Pain Visual Analog Scale (VAS)

  Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; total range = 0-10; 0 = no pain, 10 = worst pain imaginable)

  Day 7 Post-Surgery

• Score on Pain Visual Analog Scale (VAS)

  Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; total range = 0-10; 0 = no pain, 10 = worst pain imaginable)

  Day 14 Post-Surgery

• Level of Nausea Using VAS

  Any nausea experienced by the patients will be recorded by use of a VAS (total range = 0-10; 0 = no nausea, 10 = worst nausea imaginable)

  Day 2 Post-Surgery

• Level of Nausea Using VAS

  Any nausea experienced by the patients will be recorded by use of a VAS (total range = 0-10; 0 = no nausea, 10 = worst nausea imaginable)

  Day 7 Post-Surgery

• Level of Nausea Using VAS

  Any nausea experienced by the patients will be recorded by use of a VAS (total range = 0-10; 0 = no nausea, 10 = worst nausea imaginable)

  Day 14 Post-Surgery

Secondary Outcomes (7)

• CBD Consumption

  Day 2 Post-Surgery

• CBD Consumption

  Day 7 Post-Surgery

• CBD Consumption

  Day 14 Post-Surgery

• Opioid Consumption

  Day 2 Post-Surgery

• Opioid Consumption

  Day 7 Post-Surgery

Study Arms (2)

Cannabidiol (CBD)

ACTIVE COMPARATOR

Drug: CBD

Control

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CBD DRUG

25mg CBD ODTs (orally disintegrating tablet), with instructions to take CBD tablets t.i.d. (total of 50mg per dose t.i.d.) to be administered with routine post-operative pain management

Cannabidiol (CBD)

Placebo DRUG

Visually indistinguishable placebo ODTs, with instructions to take two tablets t.i.d., to be administered with routine post-operative pain management

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing an ankle fracture open reduction and internal fixation (medial malleolus, lateral malleolus, posterior malleolus, and/or syndesmosis repair), tibial plafond (pilon) open reduction and internal fixation, tibial shaft repair (open reduction internal fixation and intramedullary nail fixation), or tibial plateau open reduction and internal fixation
• Patients ages 18-75, inclusive
• Female patients must be currently practicing effective forms of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (less than 1% per year) when used consistently and correctly
• Male patients must be using an effective form of contraception

You may not qualify if:

• Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
• Younger than 18 years of age
• Older than 75 years of age
• Any patient considered a vulnerable subject: pregnant women or fetuses, children, cognitively impaired adults, prisoners
• History of cannabis abuse or dependence
• History of coagulation abnormalities and thromboembolic disease or current abnormal coagulation test values
• History of stroke or acute coronary syndromes within 3 months before surgery
• Abnormal coagulation profile
• Renal failure (serum creatinine \> 250 μmol/L \[2.83 mg/dL\]) or liver cirrhosis
• Patients that have been on pre-operative opioid management for any reason
• Patients meeting the DSM-V for major psychiatric illness, such as bipolar disorder
• Patients diagnosed with major depression, psychosis, or substance abuse disorder
• Patients with current or a history of suicidal ideation
• Breastfeeding females
• Patients with clinically significant illness, including cardiovascular disorders

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Orthopedic Hospital

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Ankle Fractures; Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Officials

• Philipp Leucht, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 24, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: December 31, 2023
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Philipp.Leucht@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)