Duloxetine Tibial Plateau

Pain, Postoperative Clinical Trial

Official title:

Effects of Duloxetine on Postoperative Pain Control and Knee Rehabilitation After Open Reduction Internal Fixation of Tibial Plateau Fractures

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04639011
• Other study ID #: H-40569
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 2022
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if Duloxetine provides effective pain management for adult patients (18 or older) undergoing tibial plateau surgery. Participants from two institutions will be randomized to one of two treatment groups: control (Group A) and treatment (Group B). Group A control group will receive placebo of sugar pill and BMC standard of care - namely postoperative, IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump (BMC standard of care). Group B, the intervention group, will receive three doses of 60 mg of oral duloxetine (right before operation, postop day 1, postop day 2).

This study is important as tibial plateau surgery's postoperative pain management primarily involved providing opioids, and if duloxetine can result in reduced narcotic intake and lower pain scores, it can potentially improve patient care, rehabilitation, early movement, and shorter length of hospital stay.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Tibial plateau fracture that requires operative fixation

• Ambulatory patient prior to fracture

Exclusion Criteria:

• Previous tibial plateau fracture on ipsilateral knee

• History of Complex Regional Pain Syndrome in ipsilateral extremity

• History of any demyelinating disorder or neurologic deficit that may contribute to altered pain tolerance/sensation

• Acute or chronic knee infection in ipsilateral extremity

• Previous total knee arthroplasty or knee hemiarthroplasty in ipsilateral knee

• Allergy to morphine (used in the SOC PCA pump)

• Pregnant or breastfeeding as determined by standard of care pre-operative urine pregnancy test

• Polytrauma

• Open fracture

• IV drug user

• Rheumatoid arthritis

• Revision cases

• Non-ambulatory

• Anatomical deformities of the knee

• Hepatic dysfunction or cirrhosis

• Taking Selective Serotonin Reuptake Inhibitor (SSRI), serotonin-norepinephrine reuptake Inhibitor (SNRI), monoamine oxidase inhibitors (MAOIs), tri- or tetra- cyclic anti-depressant

• Renal impairment (mention in patient chart and/or creatinine clearance <30)

• Moderate to severe depression

• Taking CYP1A2 inhibitors and CYP1A6 inhibitors

Related Conditions & MeSH terms

• Pain, Postoperative
• Tibial Plateau Fracture

Intervention

Drug:
• Duloxetine
Three doses of 60 mg of oral duloxetine will be given to participants (right before operation, postop day 1, postop day 2)

Other:
• Placebo
Three doses of placebo will be given to participants (right before operation, postop day 1, postop day 2).
• Standard of care (SOC) for tibial plateau surgery
Postoperative IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Westchester Medical Center	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain levels in the first 16 hours after surgery	A visual analog pain scale (VAS) will be used to assess postoperative pain levels. Participants will make a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." HIgher scores reflect greater pain levels.	every 4 hours up to 16 hours
Primary	Pain level 24 hours after surgery	A visual analog pain scale (VAS) will be used to assess the postoperative pain level. Participants will make a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." HIgher scores reflect greater pain levels.	24 hours
Primary	Pain level 36 hours after surgery	A visual analog pain scale (VAS) will be used to assess the postoperative pain level. Participants will make a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." HIgher scores reflect greater pain levels.	36 hours
Secondary	Total morphine consumption	The total morphine consumption will be calculated using the Centers for Disease Control (CDC) morphine equivalents [ME].Determine the total daily amount of morphine taken; convert to MEs by multiplying the daily dosage for each opioid by its conversion factor [which is =1 for morphine]; then add all morphine MEs together.	up to 10 days post op
Secondary	Change in knee range of motion	The knee range of motion will be abstracted from the electronic medical record. Knee range of motion ranges from 0 to 140 degrees.	6 weeks, 12 weeks
Secondary	Self reported functional status at 6 weeks	Functional status will be assessed using the Short Musculoskeletal Function Assessment (SMFA). SMFA is a 46 item questionnaire. It consists of the dysfunction index, which has 34 items for the assessment of patient function, and the bother index, which has 12 items for the assessment of how much patients are bothered by functional problems.	6 weeks
Secondary	Self reported functional status at 12 weeks	Functional status will be assessed using the Short Musculoskeletal Function Assessment (SMFA). SMFA is a 46 item questionnaire. It consists of the dysfunction index, which has 34 items for the assessment of patient function, and the bother index, which has 12 items for the assessment of how much patients are bothered by functional problems.	12 weeks
Secondary	Hospital length of stay	The hospital length of stay will be measured in days, calculated by subtracting the date of admission from the date of discharge as recorded in the electronic medical record.	12 weeks
Secondary	Time to mobilization (starting to walk)	The time to mobilization will be calculated by subtracting the date the participant started to walk post operatively from the date of surgery as recorded in the electronic medical record.	12 weeks
Secondary	Ambulation (walking) distance on post-op days 1 or 2	The walking distance will be abstracted from the electronic medical record.	Up to 2 days post op