NCT07140510

Brief Summary

To evaluate the effectiveness of Dinalbuphine Sebacate for controlling subacute pain after total knee arthroplasty

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
4mo left

Started Oct 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Oct 2025Sep 2026

First Submitted

Initial submission to the registry

August 3, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

August 3, 2025

Last Update Submit

August 18, 2025

Conditions

Osteo Arthritis of the KneeTotal Knee Anthroplasty

Keywords

Dinalbuphine SebacateNaldebainSubacute painpostoperative paintotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale for pain (VAS 0-100)

    Visual analog scale for pain at rest and on motion (knee flexion 90 degrees) using 0-100 mm, where a score of 0 represented no pain and 100 indicated the most severe pain

    Record every 12 hours after surgery until 2 weeks postoperatively, then once weekly until 12 weeks postopertively

Secondary Outcomes (7)

  • The amount of analgesic drug used

    During hospitalization and at home until 12 weeks after surgery

  • Adverse effects

    The first week after surgery

  • Length of stay

    During hospitalization (from admission to discharge)

  • Modified WOMAC score

    At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively

  • Forgotten Joint Score

    At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively

  • +2 more secondary outcomes

Other Outcomes (1)

  • Rate of closed manipulation

    At 3 months postoperatively

Study Arms (2)

Dinalbuphine Sebacate

EXPERIMENTAL

Naldebain 150mg/2mL IM

Drug: Dinalbuphine Sebacate

Placebo

PLACEBO COMPARATOR

Normal saline 2 mL IM

Drug: Normal Saline

Interventions

Dinalbuphine SebacateDRUG

Dinalbuphine Sebacate 150 mg intramuscular injection after spinal anesthesia and adductor canal block in the same side of TKA

Dinalbuphine Sebacate
Normal SalineDRUG

Normal saline 2 mL intramuscular injection after spinal anesthesia and adddutor canal block

Placebo

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoarthritic knee patients underwent unilateral primary TKA
  • Age 50-90 years
  • ASA class I-III
  • Participants understand and consent to the protocol of the trial

You may not qualify if:

  • Morbid obesity (BMI\>40)
  • Knee osteoarthritis from inflammatory knee arthritis, trauma, infection
  • Previous knee surgery
  • Cognitive disorder
  • Liver disease
  • Allergy to NSAIDs, opioids, sesame oil, and benzyl benzoate
  • CYP3A4 inhibitor and inducer drugs used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thammasat University

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location

Related Publications (1)

  • Yeh CY, Jao SW, Chen JS, Fan CW, Chen HH, Hsieh PS, Wu CC, Lee CC, Kuo YH, Hsieh MC, Huang WS, Chung YC, Liou TY, Chiu HH, Tseng WK, Lee KC, Wang JY. Sebacoyl Dinalbuphine Ester Extended-release Injection for Long-acting Analgesia: A Multicenter, Randomized, Double-Blind, And Placebo-controlled Study in Hemorrhoidectomy Patients. Clin J Pain. 2017 May;33(5):429-434. doi: 10.1097/AJP.0000000000000417.

    PMID: 27518486BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Supakit Kanitnate, M.D.

CONTACT

+66 899853635naypeng@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 3, 2025

First Posted

August 24, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

August 24, 2025

Record last verified: 2025-08

Locations

TH(1)