Post-thoracotomy PainPhase 4NCT03618225
Duloxetine Role in Reducing Opioid Consumption After Thoracotomy
A Phase 4 study testing Oral Duloxetine 60mg in people with Post-thoracotomy Pain, run by Assiut University at 1 site in Egypt.
Trial summary
A total of 60 patients scheduled for thoracotomy with the aim of excision of pleural or lung cancer, will be randomized by the use of a computer-generated table of random numbers to receive duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure or a placebo pill… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-thoracotomy Pain
- What is being tested?
- Oral Duloxetine 60mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2018to 31 Jan 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I, II, and III patients scheduled for thoracotomy for pleural or lung cancer resection.
- Age above 18 years \& less than 65 years.
- Adequate coagulation function within 30 days of surgery, defined as platelet count 100,000/mL or more, INR≤ 1.5, and partial thromboplastin time ≤40 seconds.
Who cannot join
- Allergy to duloxetine or to local anesthetics.
- Patients with educational, psychiatric (untreated or poorly controlled schizophrenia, major depression, or bipolar disorder), or communication (language) barriers that would prevent understanding of the informed consent \& preclude accurate assessment of postoperative pain and/or ability to answer questions about pain.
- Patients with severe renal and/or liver disease.
- History of chronic pain, long term narcotic use and/or antidepressants.
- Reasons for exclusion after randomization will be protocol violations or patient request.
- Fever, evidence of infection, or other coexisting medical conditions that would preclude epidural placement.
Trial locations and contacts
1 site in 1 country.
About this study
A total of 60 patients scheduled for thoracotomy with the aim of excision of pleural or lung cancer, will be randomized by the use of a computer-generated table of random numbers to receive duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure or a placebo pill following the same time schedule.
- Conditions
- Post-thoracotomy Pain
- Being tested
- Oral Duloxetine 60mg, placebo pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Duloxetine 60mgDrug
duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure
placebo pillDrug
placebo pill orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| duloxetine group | Active comparator | duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure. Receives: Drug: Oral Duloxetine 60mg |
| placebo pill group | Placebo comparator | placebo pill orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure. Receives: Drug: placebo pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of morphine needed to treat postoperative pain
Total dose of morphine needed to treat postoperative pain over 48 hours of study period
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start15 Aug 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-thoracotomy PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed H Othman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618225
- Sponsor's protocol ID
- IORG0006563
- Status last verified
- Oct 2021
- First submitted
- 14 Jul 2018
- Last updated
- 14 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duloxetine Role in Reducing Opioid Consumption After Thoracotomy
- ClinicalTrials.gov ID
- NCT03618225
- Acronym / sponsor ID
- IORG0006563
- Conditions
- Post-thoracotomy Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of 60 patients scheduled for thoracotomy with the aim of excision of pleural or lung cancer, will be randomized by the use of a computer-generated table of random numbers to receive duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure or a placebo pill following the same time schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| duloxetine group | Active comparator | Drug: Oral Duloxetine 60mgduloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure. |
| placebo pill group | Placebo comparator | Drug: placebo pillplacebo pill orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I, II, and III patients scheduled for thoracotomy for pleural or lung cancer resection.
- Age above 18 years \& less than 65 years.
- Adequate coagulation function within 30 days of surgery, defined as platelet count 100,000/mL or more, INR≤ 1.5, and partial thromboplastin time ≤40 seconds.
Key exclusion criteria (6 listed)
- Allergy to duloxetine or to local anesthetics.
- Patients with educational, psychiatric (untreated or poorly controlled schizophrenia, major depression, or bipolar disorder), or communication (language) barriers that would prevent understanding of the informed consent \& preclude accurate assessment of postoperative pain and/or ability to answer questions about pain.
- Patients with severe renal and/or liver disease.
- History of chronic pain, long term narcotic use and/or antidepressants.
- Reasons for exclusion after randomization will be protocol violations or patient request.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Duloxetine 60mgduloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure | Drug | duloxetine group |
| placebo pillplacebo pill orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure | Drug | placebo pill group |
Primary outcome
Total dose of morphine needed to treat postoperative pain
Time frame: 48 hours
Total dose of morphine needed to treat postoperative pain over 48 hours of study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Duloxetine 60mg in people with Post-thoracotomy Pain, run by Assiut University at 1 site in Egypt.
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 6 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 14 Oct 2021. 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 Egypt. 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?
Total dose of morphine needed to treat postoperative pain (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2021.