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AnesthesiologyPhase 4NCT05115955

PO Pain Management With Extended-release Dinalbuphine Sebacate in Patients Undergoing Arthroscopic Shoulder Surgery

A Phase 4 study testing DS group in people with Anesthesiology and Orthopedic, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Postoperative pain is common, and the pain intensity can be moderate to severe depending on the site of surgery during the first few days after surgery, and an estimated 15% to 45% experience chronic postsurgical pain. When poorly controlled, the pain can have a significant effect on patient recovery. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Anesthesiology, Orthopedic
What is being tested?
DS group
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
1 siteTaiwan
Study dates
11 Nov 2021to 30 Jun 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Scheduled to undergo arthroscopic shoulder surgery.
  • American Society of Anesthesiology Physical Class 1-3.
  • Ability and willingness to provide informed consent.

Who cannot join

  • Not willing to adhere to the study visit schedule.
  • With a history of hypersensitivity or allergy to opioids, NSAIDs or sesame oil.
  • With a medical history that may predispose them to abnormal intracranial pressure.
  • Any history of narcotic dependency, addiction, or withdrawal.
  • Any clinically significant condition that may interfere with study assessments.
  • Pregnant or breastfeeding.
  • Nonregular sinus cardiac rhythm or implanted pacemakers.
  • Prescribed antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists, or antiarrhythmic agents.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Tri-Service General Hospital

    Taipei, Taiwan, 114

Other trials in Taiwan

About this study

Official title: Postoperative Pain Management With Extended-release Dinalbuphine Sebacate in Patients Undergoing Arthroscopic Shoulder Surgery: a Randomized,Double-blind Study

Postoperative pain is common, and the pain intensity can be moderate to severe depending on the site of surgery during the first few days after surgery, and an estimated 15% to 45% experience chronic postsurgical pain. When poorly controlled, the pain can have a significant effect on patient recovery. Proper management of postoperative pain is needed to relieve suffering and lead to earlier mobilization, shortened hospital stay, reduced hospital costs, and increased patient satisfaction. The currently proposed clinical use of Dinalbuphine Sebacate is to administer a single dose of NALDEBAIN® intramuscularly approximately 12 to 24 hours prior to the planned surgery for pain relief. Several clinical studies of NALDEBAIN® have been published, such as the use in laparotomy and laparoscopic cholecystectomy. However, toward the arthroscopic shoulder surgery, no article or report has been available publicly yet. The primary objective of this study is to determine the safety and efficacy of single doses of intramuscular NALDEBAIN® on patients scheduled to undergo arthroscopic shoulder surgery.

Read the detailed description

This is a randomized, double-blind, placebo controlled study. Patients scheduled to undergo arthroscopic shoulder surgery will be invited to participate in this study. After obtaining the written informed consent, each subject should be sequentially assigned an individual screening number instead of his/her name, chart number or identification. Subjects will be randomized to two groups, DS group and Control group. Both groups should be treated with both routine analgesic regimen and a dose of investigational product. Random numbers and assignment treatment were generated by computer program before this study initiated. Statistical analyses should be performed on the data to compare the two groups. Numerical variables will be present with mean and standard deviation and categorical variables will be present with number and percentage.

Being tested
DS group, Control group
Keywords
Analgesia, Acute postoperative pain, Arthroscopic shoulder surgery, Randomized controlled study (RCT), Dinalbuphine sebacate, NALDEBAIN
Medical subject headings
Agnosia, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DS groupDrug

    Also called NALDEBAIN®

    In DS group, subjects will receive intramuscular single dose of NALDEBAIN® at least 12 hours before surgery.

  • Control groupDrug

    Also called Sesame oil

    In Control group, subjects will receive intramuscular 2 ml sesame oil at least 12 hours before surgery.

Study groups in NCT05115955
Study groupRoleWhat they receive
DS groupExperimentalCombination of routine analgesic regimen and preoperative administration of 2 ml NALDEBAIN® ER Injection (150 mg Dinalbuphine Sebacate, 75 mg/ml, 2 ml/vial).
Receives: Drug: DS group
Control groupPlacebo comparatorCombination of routine analgesic regimen and preoperative administration of 2 ml sesame oil (2 ml/vial).
Receives: Drug: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute postoperative pain intensity

    Mean pain intensity scored by numeric rating scale (NRS). Numerical Rating Scale (NRS) was a 11-point scale on which 0 represented "no pain" and 10 represented the" worst pain ever".

    Measured: Within 1 day after surgery

  2. Brief Pain Inventory

    Mean scores of each item in Brief Pain Inventory (BPI). Patients fill out 11 different NRS that ask about pain intensity and the effect of the pain on their ability to function during various activities of daily living. The severity scores range from 0 (no pain) to 10 (the most severe pain).

    Measured: Within 1 day after surgery

Secondary outcomes (6)

  1. Postoperative pain intensity

    Mean pain intensity scored by numeric rating scale (NRS). Numerical Rating Scale (NRS) was a 11-point scale on which 0 represented "no pain" and 10 represented the" worst pain ever".

    Measured: In postanesthesia care unit (PACU), and 6 hours, 7 days, 90 days, and 180 days after surgery

  2. Consumption of analgesics

    The consumption of total amount (mg) of supplemental analgesics administered after surgery.

    Measured: Within 7 days after surgery

  3. Time to the first dose of rescue medication

    Time from the end of surgery to the first rescue medication use.

    Measured: Up to 7 days after surgery

  4. Brief Pain Inventory

    Mean scores of each item in Brief Pain Inventory (BPI). Patients fill out 11 different NRS that ask about pain intensity and the effect of the pain on their ability to function during various activities of daily living. The severity scores range from 0 (no pain) to 10 (the most severe pain).

    Measured: At baseline, 1 day, 7 days, 90 days, 180 days after surgery

  5. Satisfaction assessed by a 5-point scale

    Each subject should be asked the following question: "How satisfied were you with your post-surgical analgesia"? Subjects should be asked to classify themselves as either: 1=highly satisfied, 2=satisfied, 3=uncertain, 4=dissatisfied or 5=very dissatisfied.

    Measured: 7 days after surgery

  6. Incidence of adverse events

    The incidence of postoperative adverse events occurring during 7 days after surgery, especially the ones related to analgesics.

    Measured: Within 7 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2021
  2. Study start11 Nov 2021
  3. Primary completion31 May 2024
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05115955
Sponsor's protocol ID
B202105153
Status last verified
Nov 2024
First submitted
27 Oct 2021
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing DS group in people with Anesthesiology and Orthopedic, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute postoperative pain intensity (time frame: Within 1 day after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05115955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.

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