A RCT Comparing Dronabinol to a Placebo for Post-operative Pain in Total Joint Arthroplasty

Osteoarthritis, Knee Clinical Trial

— dronabinol  

Official title:

A Prospective, Randomized, Double Blind Trial Comparing Dronabinol to a Placebo in the Management of Post-operative Pain in Total Joint Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04298528
• Other study ID #: 1554107
• Status: Recruiting
• Phase: Phase 3
• Start date: February 5, 2020
• Est. completion date: February 5, 2025

Study information

• Verified date: January 2023
• Source: Colorado Joint Replacement
• Contact: Rose Johnson
• Phone: 3032602940
• Email: roseannjohnson[@]centura.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study was to determine if cannabinoid use decreases narcotic consumption in patients undergoing total knee arthroplasty (TKA).

Description:

Subjects enrolled will be randomized into one of two groups either receiving the study drug or a placebo and will be followed for the first 6 weeks with regards to outcomes data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: February 5, 2025
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Provision of signed and dated informed consent from

• Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study.

• Male or Female

• Age 21-75

• Unilateral total knee arthroplasty at Colorado Joint Replacement

• All individuals will be screened for drug use (including cannabis) at their preoperative appointment

• Ability to take oral medication and be willing to adhere to the dronabinol regimen

• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.

• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

Exclusion Criteria:

• Narcotic use in the past 6 weeks

• Regular cannabis use in the past 3 months

• Major depression or anxiety disorders

• Documented psychiatric illness (e.g. bipolar, schizophrenia)

• Seizure disorder

• Current or previous history of drug and alcohol abuse

• Known allergic reactions to components of dronabinol

• Tobacco use in the past 90 days

• Treatment with another investigational drug

• Patients that cannot receive spinal anesthesia

• Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)

• Patients that are not able to go home after leaving the hospital and require a short term rehabilitation facility

Related Conditions & MeSH terms

• Osteoarthritis, Knee
• Pain, Postoperative

Intervention

Drug:
• Dronabinol
2.5mg 2 times a day for 30 days after total knee replacement

Other:
• Placebo
2 times a day for 30 days after total knee replacement

Locations

Country	Name	City	State
United States	Colorado Joint Replacement	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado Joint Replacement

Country where clinical trial is conducted

United States, 

References & Publications (12)

Cancienne JM, Patel KJ, Browne JA, Werner BC. Narcotic Use and Total Knee Arthroplasty. J Arthroplasty. 2018 Jan;33(1):113-118. doi: 10.1016/j.arth.2017.08.006. Epub 2017 Aug 17. — View Citation

Chan MH, Knoepke CE, Cole ML, McKinnon J, Matlock DD. Colorado Medical Students' Attitudes and Beliefs About Marijuana. J Gen Intern Med. 2017 Apr;32(4):458-463. doi: 10.1007/s11606-016-3957-y. Epub 2017 Jan 17. — View Citation

Di Marzo V, Bifulco M, De Petrocellis L. The endocannabinoid system and its therapeutic exploitation. Nat Rev Drug Discov. 2004 Sep;3(9):771-84. doi: 10.1038/nrd1495. — View Citation

Fitzcharles MA, Hauser W. Cannabinoids in the Management of Musculoskeletal or Rheumatic Diseases. Curr Rheumatol Rep. 2016 Dec;18(12):76. doi: 10.1007/s11926-016-0625-5. — View Citation

Hannon CP, Calkins TE, Li J, Culvern C, Darrith B, Nam D, Gerlinger TL, Buvanendran A, Della Valle CJ. The James A. Rand Young Investigator's Award: Large Opioid Prescriptions Are Unnecessary After Total Joint Arthroplasty: A Randomized Controlled Trial. J Arthroplasty. 2019 Jul;34(7S):S4-S10. doi: 10.1016/j.arth.2019.01.065. Epub 2019 Feb 4. — View Citation

Hayes MJ, Brown MS. Legalization of medical marijuana and incidence of opioid mortality. JAMA Intern Med. 2014 Oct;174(10):1673-4. doi: 10.1001/jamainternmed.2014.2716. No abstract available. — View Citation

Heng M, McTague MF, Lucas RC, Harris MB, Vrahas MS, Weaver MJ. Patient Perceptions of the Use of Medical Marijuana in the Treatment of Pain After Musculoskeletal Trauma: A Survey of Patients at 2 Trauma Centers in Massachusetts. J Orthop Trauma. 2018 Jan;32(1):e25-e30. doi: 10.1097/BOT.0000000000001002. — View Citation

Hickernell TR, Lakra A, Berg A, Cooper HJ, Geller JA, Shah RP. Should Cannabinoids Be Added to Multimodal Pain Regimens After Total Hip and Knee Arthroplasty? J Arthroplasty. 2018 Dec;33(12):3637-3641. doi: 10.1016/j.arth.2018.07.027. Epub 2018 Aug 3. — View Citation

Jennings JM, Williams MA, Levy DL, Johnson RM, Eschen CL, Dennis DA. Has Self-reported Marijuana Use Changed in Patients Undergoing Total Joint Arthroplasty After the Legalization of Marijuana? Clin Orthop Relat Res. 2019 Jan;477(1):95-100. doi: 10.1097/CORR.0000000000000339. — View Citation

Khelemsky Y, Goldberg AT, Hurd YL, Winkel G, Ninh A, Qian L, Oprescu A, Ciccone J, Katz DJ. Perioperative Patient Beliefs Regarding Potential Effectiveness of Marijuana (Cannabinoids) for Treatment of Pain: A Prospective Population Survey. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):652-659. doi: 10.1097/AAP.0000000000000654. — View Citation

Menendez ME, Ring D, Bateman BT. Preoperative Opioid Misuse is Associated With Increased Morbidity and Mortality After Elective Orthopaedic Surgery. Clin Orthop Relat Res. 2015 Jul;473(7):2402-12. doi: 10.1007/s11999-015-4173-5. Epub 2015 Feb 19. — View Citation

Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine Equivalence	Morphine Equivalence of pain medication used after a total knee replacement	30 day's post operative
Secondary	Nausea	Patients post operative nausea will be collected as none/mild/moderate/severe	30 day's post operative
Secondary	Defense and Veterans Pain Scale	Patients will keep a pain log after their joint replacement on a scale of 0 - 10	30 day's post operative
Secondary	The Pittsburgh Sleep Quality Index	To monitor sleeping habits	4 weeks and 6 weeks post operative
Secondary	Knee Society Score	Patient reported outcome	4 weeks post operative
Secondary	KOOS-12 Knee Survey	Patient reported outcome	6 weeks post operative
Secondary	The Veterans Rand 12-Item Health Survey	Patient reported outcome	6 weeks post operative