Postoperative PainPhase 4NCT04782310
Duloxetine vs Pregabalin for Thoracotomy Pain
A Phase 4 study testing Pregabalin and Duloxetine in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
This study investigates the effects of preoperative use of oral combination of duloxetine and Pregabalin in comparison with preoperative oral Pregabalin only in treatment of acute postoperative and prevention of chronic pain following thoracotomy surgeries. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Pregabalin and Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2021to 15 Sep 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ● Physical status ASA II, III.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
- Cancer patients undergoing posterolateral thoracotomy incision for cancer lung, mesothelioma or metastatectomy from the lung.
- Patient is able to provide a written informed consent.
Who cannot join
- ● Patients with Known sensitivity or contraindication to drug used in the study
- History of psychological disorders and/or chronic pain.
- Previous administration of antidepressants, anticonvulsants, or opioids before surgery.
- Patient refusal.
- Severe respiratory or cardiac disorders.
- Advanced liver or kidney disease.
Trial locations and contacts
1 site in 1 country.
Mary Sabry contact
Egypt1 site, 1 recruiting
- Recruiting
Bassant abdelhamid
Cairo, 1772
Bassant abdelhamid, 01224254012, bassantmohamed197@yahoo.com
About this study
Official title: Effectiveness of Adding Duloxetine to Pregabalin in Treatment of Acute Postoperative and Prevention of Chronic Pain Following Thoracotomy Surgeries; Randomized Controlled Study
This study investigates the effects of preoperative use of oral combination of duloxetine and Pregabalin in comparison with preoperative oral Pregabalin only in treatment of acute postoperative and prevention of chronic pain following thoracotomy surgeries.
Read the detailed description
75 Patients, undergoing thoracotomy surgery will be randomly allocated into three equal groups, each (n=25 ), using computerized generated random tables: Group P: will receive oral Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.
Group D:will receive oral duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast .
Group C: will receive single dose of Pregabalin 75mg + duloxetine 30mg two hour preoperatively, 75mg pregabalin 12 hour postoperative and then will continue pregabalin twice per day +duloxetine once after breakfast for one week.
The total amount of morphine consumption in the first 24 hours postoperatively, total amount of intraoperative fentanyl will be recorded, change in hemodynamics ((heart rate and mean arterial blood pressure), respiratory rate and oxygen saturation will be monitored and recorded at 0,2, 4, 8, 12 ,16 \&24 hours and Visual analogue scale at 0, 2,4, 8, 12, 16 \&24 hours postoperatively then at 3rd, 5th days, 4th week and12th week will be measured.
- Conditions
- Postoperative Pain
- Being tested
- Pregabalin, Duloxetine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.
DuloxetineDrug
Duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast .
| Study group | Role | What they receive |
|---|---|---|
| Group Pregabalin | Experimental | Patients will receive oral Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day. Receives: Drug: Pregabalin |
| Group Duloxetine | Experimental | Patients will receive oral duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast . Receives: Drug: Duloxetine |
| Group Pregabalin& Duloxetine | Experimental | Patients will receive single dose of Pregabalin 75mg + duloxetine 30mg two hour preoperatively, 75mg pregabalin 12 hour postoperative and then will continue pregabalin twice per day +duloxetine once after breakfast for one week. Receives: Drug: Pregabalin; Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: 24 hours postoperative
Secondary outcomes (4)
Visual analogue scale
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: 12 weeks
Total dose of intraoperative fentanyl.
The total dose of intraoperative fentanyle administration rather than the dose used in induction
Measured: 2 hours intraoperative
Heart rate
Heart rate will be measured preoperative as baseline value, intraoperative and postoperative
Measured: 24 hours
Mean arterial pressure
Mean arterial blood pressure will be measured preoperative as baseline value, intraoperative and postoperative.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start10 Mar 2021
- Primary completion10 Aug 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassant M. Abdelhamid, Cairo University
- Investigators
- Bassant abdelhamid, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782310
- Sponsor's protocol ID
- MS-386-2020
- Status last verified
- May 2021
- First submitted
- 1 Mar 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altiparmak B, Guzel C, Gumus Demirbilek S. Comparison of Preoperative Administration of Pregabalin and Duloxetine on Cognitive Functions and Pain Management After Spinal Surgery: A Randomized, Double-blind, Placebo-controlled Study. Clin J Pain. 2018 Dec;34(12):1114-1120. doi: 10.1097/AJP.0000000000000640.
PubMed 30020088Gilron I, Chaparro LE, Tu D, Holden RR, Milev R, Towheed T, DuMerton-Shore D, Walker S. Combination of pregabalin with duloxetine for fibromyalgia: a randomized controlled trial. Pain. 2016 Jul;157(7):1532-40. doi: 10.1097/j.pain.0000000000000558.
PubMed 26982602
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Adding Duloxetine to Pregabalin in Treatment of Acute Postoperative and Prevention of Chronic Pain Following Thoracotomy Surgeries; Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04782310
- Acronym / sponsor ID
- MS-386-2020
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 10 Aug 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 4 Mar 2021 (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.
This study investigates the effects of preoperative use of oral combination of duloxetine and Pregabalin in comparison with preoperative oral Pregabalin only in treatment of acute postoperative and prevention of chronic pain following thoracotomy surgeries.
Detailed description
75 Patients, undergoing thoracotomy surgery will be randomly allocated into three equal groups, each (n=25 ), using computerized generated random tables: Group P: will receive oral Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.
Group D:will receive oral duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast .
Group C: will receive single dose of Pregabalin 75mg + duloxetine 30mg two hour preoperatively, 75mg pregabalin 12 hour postoperative and then will continue pregabalin twice per day +duloxetine once after breakfast for one week.
The total amount of morphine consumption in the first 24 hours postoperatively, total amount of intraoperative fentanyl will be recorded, change in hemodynamics ((heart rate and mean arterial blood pressure), respiratory rate and oxygen saturation will be monitored and recorded at 0,2, 4, 8, 12 ,16 \&24 hours and Visual analogue scale at 0, 2,4, 8, 12, 16 \&24 hours postoperatively then at 3rd, 5th days, 4th week and12th week will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Pregabalin | Experimental | Drug: PregabalinPatients will receive oral Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day. |
| Group Duloxetine | Experimental | Drug: DuloxetinePatients will receive oral duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast . |
| Group Pregabalin& Duloxetine | Experimental | Drug: Pregabalin, Drug: DuloxetinePatients will receive single dose of Pregabalin 75mg + duloxetine 30mg two hour preoperatively, 75mg pregabalin 12 hour postoperative and then will continue pregabalin twice per day +duloxetine once after breakfast for one week. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ● Physical status ASA II, III.
Key exclusion criteria (6 listed)
- ● Patients with Known sensitivity or contraindication to drug used in the study
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 |
|---|---|---|
| PregabalinPregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day. | Drug | Group Pregabalin, Group Pregabalin& Duloxetine |
| DuloxetineDuloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast . | Drug | Group Duloxetine, Group Pregabalin& Duloxetine |
Primary outcome
Visual analogue scale
Time frame: 24 hours postoperative
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
4 secondary outcomes
Visual analogue scale
Time frame: 12 weeks
Total dose of intraoperative fentanyl.
Time frame: 2 hours intraoperative
Heart rate
Time frame: 24 hours
Mean arterial pressure
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Background: PubMed 30020088Altiparmak B, Guzel C, Gumus Demirbilek S. Comparison of Preoperative Administration of Pregabalin and Duloxetine on Cognitive Functions and Pain Management After Spinal Surgery: A Randomized, Double-blind, Placebo-controlled Study. Clin J Pain. 2018 Dec;34(12):1114-1120. doi: 10.1097/AJP.0000000000000640.
- Background: PubMed 26982602Gilron I, Chaparro LE, Tu D, Holden RR, Milev R, Towheed T, DuMerton-Shore D, Walker S. Combination of pregabalin with duloxetine for fibromyalgia: a randomized controlled trial. Pain. 2016 Jul;157(7):1532-40. doi: 10.1097/j.pain.0000000000000558.
- Individual participant dataSharing planned: No
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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.
Mary Sabry contact
Bassant abdelhamid principal investigator
Cairo University
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 Pregabalin and Duloxetine in people with Postoperative Pain, run by Cairo 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 5 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: status not confirmed, as of the sponsor's last update on 2 Jun 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bassant Abdelhamid (01224254012, bassantmohamed197@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: 24 hours postoperative). 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 NCT04782310, which also lists 2 linked publications.
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 2 Jun 2021.