Duloxetine Tibial Plateau

NCT04639011 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: H-40569
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Tibial Plateau Fracture; Pain, Postoperative

Keywords

Duloxetine; VAS pain scores; Patient Controlled Analgesia (PCA)

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (7)

• Total morphine consumption

  up to 10 days post op

• Change in knee range of motion

  6 weeks, 12 weeks

• Self reported functional status at 6 weeks

  6 weeks

• Self reported functional status at 12 weeks

  12 weeks

• Hospital length of stay

  12 weeks

Study Arms (2)

Group A Placebo

ACTIVE COMPARATOR

Participants randomized to Group A will receive placebo (sugar pill) and Boston Medical Center (BMC) standard of care.

Other: Placebo; Other: Standard of care (SOC) for tibial plateau surgery

Groups B Intervention

EXPERIMENTAL

Participants randomized to Group B will receive duloxetine and Boston Medical Center (BMC) standard of care.

Drug: Duloxetine; Other: Standard of care (SOC) for tibial plateau surgery

Interventions

Duloxetine DRUG

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

Also known as: Serotonin-norepinephrine reuptake inhibitor (SNRI)

Groups B Intervention

Placebo OTHER

Three doses of placebo will be given to participants (right before operation, postop day 1, postop day 2).

Also known as: Sugar pill

Group A Placebo

Standard of care (SOC) for tibial plateau surgery OTHER

Postoperative IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump.

Group A Placebo; Groups B Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tibial plateau fracture that requires operative fixation
• Ambulatory patient prior to fracture

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

MeSH Terms

Conditions

Tibial Plateau Fractures; Pain, Postoperative

Interventions

Duloxetine Hydrochloride; Sugars; Standard of Care

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Wounds and Injuries; Tibial Fractures; Knee Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Seroos Salavati, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: October 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)