Dinalbuphine Sebacate in Postoperative Pain Control After TKA

NCT ID: NCT07140510

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-09-30

Brief Summary

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

Detailed Description

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A single dose of intramuscular Dinalbuphine Sebacate can mitigate pain for up to 1 week after TKA

Conditions

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Osteo Arthritis of the Knee Total Knee Anthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dinalbuphine Sebacate

Naldebain 150mg/2mL IM

Group Type EXPERIMENTAL

Dinalbuphine Sebacate

Intervention Type DRUG

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

Placebo

Normal saline 2 mL IM

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

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

Interventions

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Dinalbuphine Sebacate

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

Intervention Type DRUG

Normal Saline

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thammasat University

OTHER

Sponsor Role lead

Responsible Party

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Supakit Kanitnate

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Thammasat University

Khlong Luang, Changwat Pathum Thani, Thailand

Site Status

Countries

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Thailand

Central Contacts

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Supakit Kanitnate, M.D.

Role: CONTACT

+66 899853635

Facility Contacts

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Supakit Kanitnate, M.D.

Role: primary

+66 899853635

References

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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.

Reference Type BACKGROUND
PMID: 27518486 (View on PubMed)

Other Identifiers

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OrthoTU14

Identifier Type: -

Identifier Source: org_study_id

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