NCT04719585

Brief Summary

Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) has recently been reported to be effective in controlling pain in persistent chronic pain caused by joint surgery and arthritis. However, opioids are important drugs that still play a pivotal role in pain control after surgery. In this study, we want to investigate the difference of the result among patients who undego total knee arthroplasty (TKA), of the result of pain control after TKA from SNRI administration of duloxetine and opioid in two groups. We designed a randomized controlled study (RCT) for the effect of post-TKA pain control to determine whether SNRI is effective in controlling post-TKA pain compared to Opioid, and whether there is a difference in side effects.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.9 years

First QC Date

January 6, 2021

Last Update Submit

January 19, 2021

Conditions

Total Knee ArthroplastyOsteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

  • Pain Visual Analogue Scale

    score ranges 0 to 10, higher score means more painful

    changes of the VAS score from the day before TKA operation and at postoperative 1, 2, 6, 12, 24th weeks and 1 year

  • Brief pain inventory (BPI)

    includes 7 categories. each category score ranges 0 to 10, higher score means more painful

    changes of the BPI score from the day before TKA operation and at postoperative 1, 2, 6, 12, 24th weeks and 1 year

Secondary Outcomes (4)

  • WOMAC(Western Ontario and McMaster University Arthritis Index ) pain scale

    changes of the WOMAC score from the day before TKA operation and at postoperative 1, 2, 6, 12, 24tn weeks and 1 year

  • Intermittent and Constant Osteoarthritis pain (ICOAP) score

    changes of the ICOAP score from the day before TKA operation and at postoperative 1, 2, 6, 12, 24tn weeks and 1 year

  • SF-36(Short Form Health Survey - 36) score

    changes of the SF-36 score from the day before TKA operation and at postoperative 1, 2, 6, 12, 24tn weeks and 1 year

  • Range of Motion

    The day before TKA operation, postoperative 1, 2, 6, 12, 24 weeks and 1 year

Study Arms (2)

Experimental: Duloxetine group

EXPERIMENTAL

Prior to discharge, the drug is prescribed for a total of 6 weeks by dividing the duloxetine-administered group and the opioid-administering group, respectively. The administration period of duloxetine is 6 weeks. The follow-up periods for out-patient clinic are 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after the TKA surgery. During the follow-up period, NSAIDs will be prescribed the same in both groups. As an additional rescue medication, 650 mg of acetaminophen will be allowed to use up to 2g per day.

Drug: Duloxetine vs. Opioid

Active comparator: Opioid group

ACTIVE COMPARATOR

Prior to discharge, the drug is prescribed for a total of 6 weeks by dividing the duloxetine-administered group and the opioid-administering group, respectively. The administration period of opioid is 6 weeks. The follow-up periods for out-patient clinic are 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after the TKA surgery. During the follow-up period, NSAIDs will be prescribed the same in both groups. As an additional rescue medication, 650 mg of acetaminophen will be allowed to use up to 2g per day.

Drug: Duloxetine vs. Opioid

Interventions

Duloxetine vs. OpioidDRUG

Prior to discharge, the drug is prescribed for a total of 6 weeks by dividing the duloxetine-administered group and the opioid-administering group, respectively. The administration period of duloxetine or opioid is 6 weeks. The follow-up periods for out-patient clinic are 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after the TKA surgery. During the follow-up period, NSAIDs will be prescribed the same in both groups. As an additional rescue medication, 650 mg of acetaminophen will be allowed to use up to 2g per day.

Active comparator: Opioid groupExperimental: Duloxetine group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults over age 19
  • Patients undergoing total knee arthroplasty for osteoarthritis of the knee joint
  • Patients with a pain VAS scale of 4 or more out of 10 after TKA with a pain in the knee joint during daily activities on flat ground
  • Patients who are willing or able to follow doctor's instructions, including joint exercises
  • Patients not participating in other clinical trials
  • Patients who have received sufficient explanation for this clinical trial and agreed to participate

You may not qualify if:

  • Patients with secondary knee osteoarthritis
  • Patients with hypersensitivity reactions and serious side effects to duloxetine or opioid
  • Patients with inflammatory arthritis or crystalline arthritis
  • Local infection to the lower extremities of the pain area, sepsis, or previous neurological abnormalities.
  • Patients who underwent meniscus surgery on the knee joint in the painful area
  • If there is construction or deformation of the knee joint in the pain area
  • Patients with serious heart-related diseases such as cardiac arrest, a history of cerebral infarction, or ischemic heart disease
  • Patients with high blood pressure with poor blood pressure control (Systolic Blood Pressure of\> 150 mmHg or Diastolic Blood Pressure\> 95 mmHg)
  • Patients with abnormal liver function (ALT)\> 2.0 times the upper limit of normal (ULN) or blood urea nitrogen (BUN) or serum creatinine\> 2.0 times ULN)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Yong In, MD, PhD

CONTACT

82-10-9044-5228iy1000@catholic.ac.kr

Mansoo Kim, MD, PhD

CONTACT

82-10-7233-3875kms3779@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 22, 2021

Study Start

January 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share